Viewing Study NCT04823650


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Ignite Modification Date: 2025-12-28 @ 4:37 AM
Study NCT ID: NCT04823650
Status: COMPLETED
Last Update Posted: 2025-12-11
First Post: 2021-03-18
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Monitoring Activity And Gait In Children
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquires@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 to Day 15 (+3 days)', 'description': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Medical device site bruise', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nasopharyngitis', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Contusion', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oropharyngeal pain', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Erythema', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pruritus', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Skin indentation', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain upper', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Medical device site irritation', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Medical device site rash', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Upper respiratory tract infection', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Joint injury', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory disorder', 'notes': 'MedDRA 25.1 for Cohort A and MedDRA 27.1 for Cohort B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '0.174', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.234', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '1.21', 'spread': '0.177', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.213', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '0.171', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.231', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '0.129', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '0.115', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.252', 'groupId': 'OG001'}, {'value': '1.56', 'spread': '0.161', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.218', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.247', 'groupId': 'OG001'}, {'value': '1.43', 'spread': '0.139', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.150', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.173', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.173', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.151', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.204', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.159', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.153', 'groupId': 'OG001'}, {'value': '0.66', 'spread': '0.196', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.606', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.637', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.741', 'ciLowerLimit': '0.33', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.892', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.715', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.767', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.428', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.84', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.335', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.77', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.273', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.74', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.854', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.537', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.85', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.536', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.89', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.527', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.574', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.88', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.454', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.85', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.834', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.317', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.72', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.789', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.737', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.69', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.936', 'ciLowerLimit': '0.81', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.521', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.79', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.871', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.022', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.053', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '0.049', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.033', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.048', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '0.020', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.057', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.042', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.039', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.034', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.155', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.192', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '0.139', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.150', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.144', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.126', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.548', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.84', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.731', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.623', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.491', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.82', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.136', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.52', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.157', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.59', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.649', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.88', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.259', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.71', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.242', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.70', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.66', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.481', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.83', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.72', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.096', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.46', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.44', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.058', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.35', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.206', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.59', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.247', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.70', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.127', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.53', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.031', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.34', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.004', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.27', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.085', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.21', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.077', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.44', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.063', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.50', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.248', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.29', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.331', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.69', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.217', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.59', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.169', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.52', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set (FAS) included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.050', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.028', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.037', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.027', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '0.46', 'spread': '0.022', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.026', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.039', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.029', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.024', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.123', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.074', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '0.045', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.055', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.876', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.783', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.849', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.658', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.398', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.82', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.776', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.681', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.83', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.044', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.56', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.938', 'ciLowerLimit': '0.82', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.861', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.392', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.83', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.568', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.284', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.74', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.199', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.56', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.657', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.409', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.83', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.733', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.594', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.89', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.392', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.79', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.903', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.862', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.694', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.786', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.694', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.505', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.83', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometery data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.072', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.054', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.062', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.070', 'groupId': 'OG001'}, {'value': '0.66', 'spread': '0.065', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.075', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.046', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.087', 'groupId': 'OG001'}, {'value': '0.62', 'spread': '0.057', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.075', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '0.056', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '0.166', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.207', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.265', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.178', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.227', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '0.181', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.902', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.969', 'ciLowerLimit': '0.90', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.963', 'ciLowerLimit': '0.88', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.892', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.731', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.637', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.715', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.767', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.66', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.83', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.72', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.096', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.46', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.44', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.058', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.35', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.206', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.59', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.247', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.70', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.127', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.53', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.377', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.75', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intra-class correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.81', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.50', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.398', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.76', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.651', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.89', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.59', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.639', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.666', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.346', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.69', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Swing Duration Measured by Actigraph for Walk at Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.050', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.028', 'groupId': 'OG002'}]}]}, {'title': 'Swing Duration Measured by GAITRite for Walk at Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.037', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.027', 'groupId': 'OG002'}]}]}, {'title': 'Swing Duration Measured by APDM for Walk at Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '0.021', 'groupId': 'OG002'}]}]}, {'title': 'Swing Duration Measured by Actigraph for Walk at Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.027', 'groupId': 'OG002'}]}]}, {'title': 'Swing Duration Measured by GAITRite for Walk at Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.039', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.028', 'groupId': 'OG002'}]}]}, {'title': 'Swing Duration Measured by APDM for Walk at Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.025', 'groupId': 'OG002'}]}]}, {'title': 'Swing Duration Measured by Actigraph for Walk at Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '0.106', 'groupId': 'OG002'}]}]}, {'title': 'Swing Duration Measured by GAITRite for Walk at Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.074', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '0.045', 'groupId': 'OG002'}]}]}, {'title': 'Swing Duration Measured by APDM for Walk at Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.116', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.056', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.827', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.877', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.783', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.833', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.644', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.383', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.81', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.785', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.679', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.405', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.83', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.257', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.69', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.892', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.837', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.341', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.80', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.536', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.88', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.264', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.71', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.275', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.66', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.631', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.379', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.81', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.606', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.86', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.714', 'ciLowerLimit': '0.29', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.78', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.703', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.555', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.84', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.563', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.84', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.687', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.603', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.459', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.79', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years were required to wear the Actigraph centerpoint insight watch on the non-dominant wrist and lumbar region for at least 15 days. The wrist device had to be worn continuously, and the lumbar device was worn when the participants woke up in the morning and removed when they went to sleep at night or nap during the daytime. Participants also wore the APDM opal devices during Visit 1 (Day 1) only on both wrists, both feet, lumbar, and waist.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '0.146', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '1.35', 'spread': '0.116', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.114', 'groupId': 'OG001'}, {'value': '1.22', 'spread': '0.118', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.155', 'groupId': 'OG001'}, {'value': '1.31', 'spread': '0.109', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.195', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '0.104', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.196', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '0.110', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.122', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.104', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '0.142', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.136', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.155', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.129', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '0.155', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.569', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.612', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.444', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.85', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.254', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.70', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.875', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.793', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.467', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.78', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.705', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.585', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.558', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.486', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.222', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.68', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.729', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.727', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.592', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.624', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.669', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.376', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.81', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.755', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.614', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.424', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.83', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.648', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.89', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.586', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.86', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.759', 'ciLowerLimit': '0.38', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.692', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.614', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.89', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.605', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes of Day 1', 'description': 'Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.061', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.046', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.058', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '0.043', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.055', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '0.041', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.059', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.037', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.058', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.037', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.058', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.038', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.088', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '0.74', 'spread': '0.109', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.128', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.163', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.116', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.165', 'groupId': 'OG001'}, {'value': '0.74', 'spread': '0.116', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.985', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.976', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.973', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.984', 'ciLowerLimit': '0.95', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.963', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.945', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.985', 'ciLowerLimit': '0.96', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.974', 'ciLowerLimit': '0.91', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.968', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.019', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.45', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.977', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.886', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.781', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.962', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.902', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.58', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.978', 'ciLowerLimit': '0.80', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.855', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.886', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.94', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.801', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.878', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.983', 'ciLowerLimit': '0.94', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.891', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.923', 'ciLowerLimit': '0.77', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.987', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-laboratory visit on Day 1 during which they performed gait monitoring procedures. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '123.07', 'spread': '17.515', 'groupId': 'OG000'}, {'value': '118.17', 'spread': '13.763', 'groupId': 'OG001'}, {'value': '106.00', 'spread': '7.971', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '120.57', 'spread': '17.555', 'groupId': 'OG000'}, {'value': '117.97', 'spread': '14.652', 'groupId': 'OG001'}, {'value': '104.23', 'spread': '9.496', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '124.09', 'spread': '20.093', 'groupId': 'OG000'}, {'value': '120.04', 'spread': '13.073', 'groupId': 'OG001'}, {'value': '107.97', 'spread': '7.556', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '139.59', 'spread': '17.740', 'groupId': 'OG000'}, {'value': '134.16', 'spread': '17.301', 'groupId': 'OG001'}, {'value': '118.24', 'spread': '8.667', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '147.26', 'spread': '19.313', 'groupId': 'OG000'}, {'value': '130.42', 'spread': '16.612', 'groupId': 'OG001'}, {'value': '113.16', 'spread': '9.725', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '139.50', 'spread': '10.993', 'groupId': 'OG000'}, {'value': '137.06', 'spread': '17.574', 'groupId': 'OG001'}, {'value': '122.30', 'spread': '9.326', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.12', 'spread': '14.187', 'groupId': 'OG000'}, {'value': '81.48', 'spread': '16.704', 'groupId': 'OG001'}, {'value': '82.59', 'spread': '11.866', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.77', 'spread': '16.656', 'groupId': 'OG000'}, {'value': '76.61', 'spread': '17.346', 'groupId': 'OG001'}, {'value': '81.53', 'spread': '11.926', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.57', 'spread': '17.679', 'groupId': 'OG000'}, {'value': '78.38', 'spread': '18.100', 'groupId': 'OG001'}, {'value': '82.55', 'spread': '12.486', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.976', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.972', 'ciLowerLimit': '0.92', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.899', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.975', 'ciLowerLimit': '0.92', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.974', 'ciLowerLimit': '0.80', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.952', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.969', 'ciLowerLimit': '0.89', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.968', 'ciLowerLimit': '0.91', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.893', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.42', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.891', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.561', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.85', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.967', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.885', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.134', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.53', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.896', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.598', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.849', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.907', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.92', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.922', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.939', 'ciLowerLimit': '0.76', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.988', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.911', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.942', 'ciLowerLimit': '0.79', 'ciUpperLimit': '0.98', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.987', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Steps per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.150', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.118', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '0.082', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.118', 'groupId': 'OG001'}, {'value': '1.12', 'spread': '0.091', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.163', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.111', 'groupId': 'OG001'}, {'value': '1.12', 'spread': '0.084', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.132', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.115', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '0.073', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.123', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.079', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.076', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.155', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '0.210', 'groupId': 'OG001'}, {'value': '1.41', 'spread': '0.149', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.258', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '0.327', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '0.226', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.31', 'spread': '0.265', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '0.331', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '0.233', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.985', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.995', 'ciLowerLimit': '0.09', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.989', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.983', 'ciLowerLimit': '0.95', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.989', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.982', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.984', 'ciLowerLimit': '0.96', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.992', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.987', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Natural Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.092', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.39', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.971', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.972', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '1.00', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.725', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.91', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.946', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.939', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.152', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.52', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.967', 'ciLowerLimit': '0.84', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.965', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Fast Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.709', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.80', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.655', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.88', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.692', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.494', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.81', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.648', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.88', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.689', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.89', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Walk at Slow Speed: ActiGraph vs GAITRite vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'PRIMARY', 'title': 'Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.061', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '0.046', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.022', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.023', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.40', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.096', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.50', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.188', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.64', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.026', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.39', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.049', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.30', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.144', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.57', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '0.021', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.022', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.017', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.032', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.024', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.123', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.51', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.473', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.86', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.293', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.74', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.277', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.73', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.377', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.80', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.279', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.73', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Single support time referred to the time when only one limb was in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.072', 'groupId': 'OG001'}, {'value': '0.66', 'spread': '0.060', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.055', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.046', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.053', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.053', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.051', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '0.041', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.252', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.69', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: Actigraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.704', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.89', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: Actigraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.631', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.92', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: Actigraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.292', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.69', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: Actigraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.516', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.82', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: Actigraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.566', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.90', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: Actigraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.036', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.024', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.034', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.022', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.019', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.030', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.020', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intra-class correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.132', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.52', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intra-class correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.522', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.88', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intra-class correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.363', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.80', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.456', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.84', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.461', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.85', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.292', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.75', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Swing duration was defined as the time during which the foot was not in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.185', 'groupId': 'OG001'}, {'value': '1.12', 'spread': '0.089', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.110', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.134', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.165', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '0.084', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.132', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.043', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.31', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.284', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.68', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.332', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.72', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.041', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.44', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.289', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.68', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.306', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.70', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.048', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '0.036', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '0.035', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.034', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.596', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.86', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.902', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.97', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.944', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.614', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.882', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.96', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.939', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-lab simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '126.97', 'spread': '7.487', 'groupId': 'OG000'}, {'value': '118.54', 'spread': '11.395', 'groupId': 'OG001'}, {'value': '109.47', 'spread': '7.972', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '128.71', 'spread': '5.515', 'groupId': 'OG000'}, {'value': '122.32', 'spread': '11.001', 'groupId': 'OG001'}, {'value': '108.15', 'spread': '6.842', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '130.96', 'spread': '7.346', 'groupId': 'OG000'}, {'value': '120.51', 'spread': '8.758', 'groupId': 'OG001'}, {'value': '110.84', 'spread': '7.109', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '129.90', 'spread': '6.846', 'groupId': 'OG000'}, {'value': '122.49', 'spread': '9.919', 'groupId': 'OG001'}, {'value': '109.63', 'spread': '6.715', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.487', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.81', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.805', 'ciLowerLimit': '0.37', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.953', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.584', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.85', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.785', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.93', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.964', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Cadence referred to the number of steps taken per minute during gait cycle. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Steps per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.210', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '0.109', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.084', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.085', 'groupId': 'OG001'}, {'value': '0.95', 'spread': '0.104', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.161', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.106', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.130', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.26', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.094', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.49', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.80', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.014', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.35', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.26', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.284', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.71', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Gait speed was the time taken to walk a specified distance. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '109.23', 'spread': '42.540', 'groupId': 'OG000'}, {'value': '123.00', 'spread': '51.067', 'groupId': 'OG001'}, {'value': '154.62', 'spread': '49.399', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '103.00', 'spread': '72.623', 'groupId': 'OG000'}, {'value': '163.43', 'spread': '75.572', 'groupId': 'OG001'}, {'value': '114.46', 'spread': '87.498', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Wrist: Activity Block 1', 'categories': [{'measurements': [{'value': '187.38', 'spread': '67.463', 'groupId': 'OG000'}, {'value': '242.86', 'spread': '73.539', 'groupId': 'OG001'}, {'value': '211.15', 'spread': '80.045', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '120.77', 'spread': '57.727', 'groupId': 'OG000'}, {'value': '130.57', 'spread': '56.896', 'groupId': 'OG001'}, {'value': '154.15', 'spread': '47.430', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '125.46', 'spread': '71.906', 'groupId': 'OG000'}, {'value': '172.79', 'spread': '72.707', 'groupId': 'OG001'}, {'value': '109.15', 'spread': '72.281', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Wrist: Activity Block 2', 'categories': [{'measurements': [{'value': '210.92', 'spread': '109.188', 'groupId': 'OG000'}, {'value': '275.14', 'spread': '87.960', 'groupId': 'OG001'}, {'value': '225.69', 'spread': '98.155', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.135', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.53', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.197', 'ciLowerLimit': '-0.114', 'ciUpperLimit': '0.64', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.341', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.73', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.76', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.371', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.74', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.364', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.74', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.234', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.65', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.493', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.87', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.333', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.75', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.228', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.59', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.335', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.74', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.343', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.70', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.376', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.77', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.56', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.315', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.71', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.449', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.80', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.241', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.65', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.399', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.77', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.507', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.86', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.299', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.72', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.74', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.444', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.78', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.217', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.59', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs Actigraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.321', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.70', 'estimateComment': "Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Activity Block 1', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.099', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '0.081', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 1', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '0.069', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Activity Block 2', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.076', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '0.070', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph Lumbar: Activity Block 2', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.079', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '0.067', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.323', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.73', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.822', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.95', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.973', 'ciLowerLimit': '0.91', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 1: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.644', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.88', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.829', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.94', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Intraclass correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.93', 'ciUpperLimit': '0.99', 'estimateComment': "Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \\<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.", 'groupDescription': 'Activity Block 2: ActiGraph Lumbar vs APDM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride duration refers to the duration between successive heel contacts of the same foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort B: Total Sleep Time During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '561.21', 'spread': '43.476', 'groupId': 'OG000'}, {'value': '520.34', 'spread': '26.680', 'groupId': 'OG001'}, {'value': '459.92', 'spread': '44.421', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '567.48', 'spread': '40.483', 'groupId': 'OG000'}, {'value': '524.57', 'spread': '42.583', 'groupId': 'OG001'}, {'value': '450.53', 'spread': '54.944', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Total sleep time for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's total sleep opportunity (TSO) window and computing sleep metrics within that window.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Percentage of Time Asleep During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.65', 'spread': '1.745', 'groupId': 'OG000'}, {'value': '94.93', 'spread': '2.049', 'groupId': 'OG001'}, {'value': '94.85', 'spread': '2.481', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.85', 'spread': '2.258', 'groupId': 'OG000'}, {'value': '94.94', 'spread': '2.402', 'groupId': 'OG001'}, {'value': '94.08', 'spread': '2.762', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "The percentage of time asleep for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.", 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Number of Wake Bouts During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.74', 'spread': '2.895', 'groupId': 'OG000'}, {'value': '9.59', 'spread': '4.436', 'groupId': 'OG001'}, {'value': '9.40', 'spread': '4.171', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.69', 'spread': '2.579', 'groupId': 'OG000'}, {'value': '9.57', 'spread': '4.979', 'groupId': 'OG001'}, {'value': '9.37', 'spread': '4.651', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Number of wake bouts for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.", 'unitOfMeasure': 'Wake bouts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Sleep Onset Latency During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.64', 'spread': '0.868', 'groupId': 'OG000'}, {'value': '3.82', 'spread': '1.118', 'groupId': 'OG001'}, {'value': '2.39', 'spread': '1.428', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.69', 'spread': '1.966', 'groupId': 'OG000'}, {'value': '4.01', 'spread': '1.425', 'groupId': 'OG001'}, {'value': '3.64', 'spread': '2.291', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Sleep onset latency which is time to transition from full wakefulness to sleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Wake After Sleep Onset During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.38', 'spread': '9.022', 'groupId': 'OG000'}, {'value': '24.36', 'spread': '12.820', 'groupId': 'OG001'}, {'value': '21.62', 'spread': '12.976', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.44', 'spread': '13.112', 'groupId': 'OG000'}, {'value': '23.58', 'spread': '15.339', 'groupId': 'OG001'}, {'value': '22.01', 'spread': '12.396', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Wake after sleep onset is time for which participants were awake after having initially fallen asleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Total Scratch Duration During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.45', 'spread': '0.785', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '1.453', 'groupId': 'OG001'}, {'value': '3.35', 'spread': '1.576', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.17', 'spread': '1.138', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '1.456', 'groupId': 'OG001'}, {'value': '3.75', 'spread': '2.032', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Total scratch duration for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Total Scratch Episodes During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.74', 'spread': '9.585', 'groupId': 'OG000'}, {'value': '45.60', 'spread': '17.613', 'groupId': 'OG001'}, {'value': '46.04', 'spread': '19.338', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.81', 'spread': '14.447', 'groupId': 'OG000'}, {'value': '43.45', 'spread': '16.683', 'groupId': 'OG001'}, {'value': '49.74', 'spread': '25.354', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Total scratch episodes for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.", 'unitOfMeasure': 'Scratch episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Number of Available Minutes During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1389.08', 'spread': '28.718', 'groupId': 'OG000'}, {'value': '1386.44', 'spread': '50.327', 'groupId': 'OG001'}, {'value': '1385.76', 'spread': '28.941', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1234.49', 'spread': '173.436', 'groupId': 'OG000'}, {'value': '1260.18', 'spread': '129.136', 'groupId': 'OG001'}, {'value': '1310.20', 'spread': '86.365', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': 'Available minutes represented any recorded accelerometer data per day per device in minutes. Number of available minutes for GENEActiv and Panoramic Bracelet was derived by the in-house built Sci-kit Digital Health (SKDH) package.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Number of Minutes of Wear During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1095.45', 'spread': '145.296', 'groupId': 'OG000'}, {'value': '1099.07', 'spread': '185.868', 'groupId': 'OG001'}, {'value': '1044.66', 'spread': '153.988', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '727.98', 'spread': '226.617', 'groupId': 'OG000'}, {'value': '785.81', 'spread': '195.558', 'groupId': 'OG001'}, {'value': '789.37', 'spread': '181.889', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': 'Number of minutes of wear include the total number of minutes the device is worn including sleep time and awake time. The wear time parameter (number of minutes of wear) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Number of Wear Minutes While Awake During the At-Home Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '813.15', 'spread': '47.851', 'groupId': 'OG000'}, {'value': '883.23', 'spread': '73.627', 'groupId': 'OG001'}, {'value': '845.01', 'spread': '85.179', 'groupId': 'OG002'}]}]}, {'title': 'GENEActiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '706.48', 'spread': '85.259', 'groupId': 'OG000'}, {'value': '768.64', 'spread': '99.152', 'groupId': 'OG001'}, {'value': '775.16', 'spread': '152.259', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': 'The wear time parameter (number of wear minutes while awake) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'PRIMARY', 'title': 'Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Comfortable to Wear', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Easy to Put On', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Easy to Take Off', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Easy to Wear', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Changes the Way I Move', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Changes the Way I Behave', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Willing to Wear for 4 to 7 Days', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Willing to Wear for > 7 Days', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'If the device could follow my progress during a treatment (ttmt), I would wear it', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'If device could follow my progress during ttmt, I would want my doctor to have access to my results', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicated more comfort, except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort B.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Participants Enrolled Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': '23-Aug-2021 to 22-Sep-2021', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '23-Sep-2021 to 22-Oct-2021', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '23-Oct-2021 to 22-Nov-2021', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': '23-Nov-2021 to 22-Dec-2021', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '23-Dec-2021 to 22-Jan-2022', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '23-Jan-2022 to 22-Feb-2022', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '23-Feb-2022 to 22-Mar-2022', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '23-Mar-2022 to 22-Apr-2022', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 8 months', 'description': 'Number of participants enrolled at specified month intervals in the study is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'PRIMARY', 'title': 'Cohort A: Number of Days to Complete Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 8 months', 'description': 'Number of days to complete enrollment corresponded to the total number of days it took to enroll all study participants within the age groups of 3-5 years, 6-11 years and 12-17 years.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Natural Walk', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Fast Walk', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Slow Walk', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Carpet Walk', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Tile Walk', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Activity Block 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Activity Block 2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Number of participants who were able to perform each of the 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Percentage of tasks completed from a total of 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of tasks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Wrist device', 'categories': [{'measurements': [{'value': '21.05', 'spread': '2.461', 'groupId': 'OG000'}, {'value': '21.80', 'spread': '1.947', 'groupId': 'OG001'}, {'value': '22.01', 'spread': '2.169', 'groupId': 'OG002'}]}]}, {'title': 'Lumbar device', 'categories': [{'measurements': [{'value': '7.24', 'spread': '4.293', 'groupId': 'OG000'}, {'value': '12.51', 'spread': '3.630', 'groupId': 'OG001'}, {'value': '14.24', 'spread': '4.574', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days)', 'unitOfMeasure': 'Hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.15', 'spread': '4.413', 'groupId': 'OG000'}, {'value': '11.71', 'spread': '3.561', 'groupId': 'OG001'}, {'value': '11.69', 'spread': '2.250', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days)', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.38', 'spread': '2.534', 'groupId': 'OG000'}, {'value': '13.21', 'spread': '1.718', 'groupId': 'OG001'}, {'value': '12.54', 'spread': '2.436', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days)', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'APDM: Comfortable to Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Easy to Put On', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Easy to Take Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Easy to Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Changes the Way I Move', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': 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'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: If the device could follow my progress during a ttmt, I would wear it', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A."}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'OG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'ActiGraph (ACT) Lumbar (L): Comfortable to Wear', 'categories': [{'title': '0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'ACT L: Easy to Put On', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ACT L: Easy to Take Off', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'ACT L: Easy to Wear', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'ACT L: Changes the Way I Move', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ACT L: Changes the Way I Behave', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'ACT L: Willing to Wear for 4 to 7 Days', 'categories': [{'title': '0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ACT L: Willing to Wear for > 7 Days', 'categories': [{'title': '0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ACT L: If the device could follow my progress during a treatment, I would wear it', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'ActiGraph (ACT) Wrist (W): Comfortable to Wear', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: Easy to Put On', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: Easy to Take Off', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: Easy to Wear', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: Changes the Way I Move', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: Changes the Way I Behave', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: Willing to Wear for 4 to 7 Days', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: Willing to Wear for > 7 Days', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ACT W: If the device could follow my progress during a ttmt, I would wear it', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (+ 3 days)', 'description': 'Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.007', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.007', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.007', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.007', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.006', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.006', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.006', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.006', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Single limb support time referred to the time when only one limb was in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.012', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.012', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.012', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.012', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.006', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.006', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.006', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.006', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Swing time was defined as the time during which the foot was not in contact with the ground. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.016', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.017', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.016', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.016', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.009', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.009', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.009', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.009', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '115.08', 'spread': '2.236', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '116.79', 'spread': '2.240', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '117.56', 'spread': '2.236', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '119.62', 'spread': '2.236', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Cadence referred to the number of steps taken per minute during gait cycle. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Steps per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.027', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.027', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.027', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.027', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Gait speed was the time taken to walk a specified distance. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Meters per second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Participants Aged 3-17 Years', 'description': "Participants aged 3 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}], 'classes': [{'title': 'ActiGraph: Carpet', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.018', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Carpet', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.018', 'groupId': 'OG000'}]}]}, {'title': 'ActiGraph: Tile', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.018', 'groupId': 'OG000'}]}]}, {'title': 'APDM: Tile', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.018', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride duration refers to the duration between successive heel contacts of the same foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.'}, {'type': 'SECONDARY', 'title': 'Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.65', 'spread': '1.051', 'groupId': 'OG000'}, {'value': '22.80', 'spread': '1.317', 'groupId': 'OG001'}, {'value': '22.60', 'spread': '1.590', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 up to Day 7', 'unitOfMeasure': 'Hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort B.'}, {'type': 'SECONDARY', 'title': 'Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '0.035', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '0.032', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.039', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.041', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.056', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.030', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.030', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.031', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.166', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.183', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.121', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.243', 'groupId': 'OG001'}, {'value': '0.52', 'spread': '0.148', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.179', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.199', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.122', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'SECONDARY', 'title': 'Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.036', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.026', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.027', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.034', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '0.027', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.029', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.030', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.025', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.028', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.356', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.102', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.095', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.088', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.151', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.112', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. 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Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.186', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.062', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '0.055', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.064', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '0.051', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.061', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.054', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.069', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.048', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.064', 'groupId': 'OG001'}, {'value': '0.62', 'spread': '0.050', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.050', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '0.044', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.452', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.340', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '0.230', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.245', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.342', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '0.232', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.256', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.352', 'groupId': 'OG001'}, {'value': '0.95', 'spread': '0.228', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'SECONDARY', 'title': 'Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.036', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.026', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.032', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.026', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.034', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '0.027', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '0.029', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.026', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.026', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.182', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.137', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.102', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.095', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.109', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'SECONDARY', 'title': 'Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.182', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.166', 'groupId': 'OG001'}, {'value': '1.29', 'spread': '0.149', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.122', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '1.37', 'spread': '0.094', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.104', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.091', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '0.093', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.320', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.163', 'groupId': 'OG001'}, {'value': '1.48', 'spread': '0.197', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.106', 'groupId': 'OG001'}, {'value': '1.56', 'spread': '0.159', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '1.39', 'spread': '0.120', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.244', 'groupId': 'OG001'}, {'value': '1.06', 'spread': '0.127', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.174', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.217', 'groupId': 'OG001'}, {'value': '1.11', 'spread': '0.122', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.157', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.194', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '0.112', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'SECONDARY', 'title': 'Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.046', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.037', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.037', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.046', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.037', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.038', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.036', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.033', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.418', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.241', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.164', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.157', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.229', 'groupId': 'OG001'}, {'value': '0.76', 'spread': '0.165', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.171', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.247', 'groupId': 'OG001'}, {'value': '0.76', 'spread': '0.162', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'SECONDARY', 'title': 'Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '138.45', 'spread': '26.272', 'groupId': 'OG000'}, {'value': '119.94', 'spread': '10.909', 'groupId': 'OG001'}, {'value': '108.89', 'spread': '7.163', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '144.80', 'spread': '11.373', 'groupId': 'OG000'}, {'value': '122.16', 'spread': '10.433', 'groupId': 'OG001'}, {'value': '109.98', 'spread': '7.504', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '136.44', 'spread': '7.962', 'groupId': 'OG000'}, {'value': '122.15', 'spread': '10.904', 'groupId': 'OG001'}, {'value': '110.45', 'spread': '7.473', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '158.13', 'spread': '28.017', 'groupId': 'OG000'}, {'value': '144.41', 'spread': '14.793', 'groupId': 'OG001'}, {'value': '121.24', 'spread': '9.227', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '166.43', 'spread': '20.297', 'groupId': 'OG000'}, {'value': '145.96', 'spread': '16.900', 'groupId': 'OG001'}, {'value': '122.86', 'spread': '9.042', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '147.01', 'spread': '11.303', 'groupId': 'OG000'}, {'value': '141.76', 'spread': '13.502', 'groupId': 'OG001'}, {'value': '122.66', 'spread': '8.589', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '106.99', 'spread': '45.694', 'groupId': 'OG000'}, {'value': '88.81', 'spread': '24.208', 'groupId': 'OG001'}, {'value': '81.21', 'spread': '16.065', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '119.25', 'spread': '36.642', 'groupId': 'OG000'}, {'value': '93.91', 'spread': '25.728', 'groupId': 'OG001'}, {'value': '82.24', 'spread': '16.459', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '106.81', 'spread': '28.903', 'groupId': 'OG000'}, {'value': '92.80', 'spread': '25.727', 'groupId': 'OG001'}, {'value': '82.07', 'spread': '16.271', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Steps per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'SECONDARY', 'title': 'Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.209', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.228', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '0.176', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.144', 'groupId': 'OG001'}, {'value': '1.25', 'spread': '0.124', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.147', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.144', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '0.120', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '0.345', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '0.191', 'groupId': 'OG001'}, {'value': '1.50', 'spread': '0.262', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.234', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '0.205', 'groupId': 'OG001'}, {'value': '1.59', 'spread': '0.225', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.130', 'groupId': 'OG001'}, {'value': '1.43', 'spread': '0.162', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.298', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.223', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '0.171', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.256', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.280', 'groupId': 'OG001'}, {'value': '0.76', 'spread': '0.174', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.224', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.273', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.168', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B."}, {'type': 'SECONDARY', 'title': 'Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG001', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'OG002', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'classes': [{'title': 'Panoramic Bracelet: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.257', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '1.11', 'spread': '0.078', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.091', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '0.073', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Natural Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '0.074', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.075', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.094', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.071', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Fast Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.079', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.069', 'groupId': 'OG002'}]}]}, {'title': 'Panoramic Bracelet: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.24', 'spread': '0.552', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.477', 'groupId': 'OG001'}, {'value': '1.53', 'spread': '0.326', 'groupId': 'OG002'}]}]}, {'title': 'GAITRite: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.12', 'spread': '0.352', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '0.473', 'groupId': 'OG001'}, {'value': '1.52', 'spread': '0.330', 'groupId': 'OG002'}]}]}, {'title': 'APDM: Slow Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.20', 'spread': '0.336', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.489', 'groupId': 'OG001'}, {'value': '1.52', 'spread': '0.330', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'FG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'FG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'FG003', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'FG004', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'FG005', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In this observational study, healthy pediatric participants (aged 3-17) were enrolled in 2 cohorts: Cohort A and B. A total of 87 participants (Cohort A: 40 and Cohort B: 47) were screened and enrolled in the study. No intervention was administered during this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: Participants Aged 3-5 Years', 'description': "Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1."}, {'id': 'BG001', 'title': 'Cohort A: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'BG002', 'title': 'Cohort A: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'BG003', 'title': 'Cohort B: Participants Aged 3-5 Years', 'description': 'Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'BG004', 'title': 'Cohort B: Participants Aged 6-11 Years', 'description': 'Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'BG005', 'title': 'Cohort B: Participants Aged 12-17 Years', 'description': 'Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Cohort A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '4.38', 'spread': '0.65', 'groupId': 'BG000'}, {'value': '9.00', 'spread': '1.80', 'groupId': 'BG001'}, {'value': '14.77', 'spread': '1.59', 'groupId': 'BG002'}, {'value': '9.38', 'spread': '4.48', 'groupId': 'BG006'}]}]}, {'title': 'Cohort B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '0.82', 'groupId': 'BG003'}, {'value': '8.53', 'spread': '1.62', 'groupId': 'BG004'}, {'value': '13.94', 'spread': '1.68', 'groupId': 'BG005'}, {'value': '9.23', 'spread': '4.26', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '49', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '76', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-12', 'size': 1205038, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-21T14:20', 'hasProtocol': True}, {'date': '2023-09-06', 'size': 505654, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-21T14:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2021-03-18', 'resultsFirstSubmitDate': '2025-10-21', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-25', 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometery data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes of Day 1', 'description': 'Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-laboratory visit on Day 1 during which they performed gait monitoring procedures. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing ActiGraph and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).'}, {'measure': 'Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Single support time referred to the time when only one limb was in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Swing duration was defined as the time during which the foot was not in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-lab simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Cadence referred to the number of steps taken per minute during gait cycle. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Gait speed was the time taken to walk a specified distance. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride duration refers to the duration between successive heel contacts of the same foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \\[activity block 1\\], approximately 5 minutes of break and approximately 7 minutes of activities \\[activity block 2\\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).'}, {'measure': 'Cohort B: Total Sleep Time During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Total sleep time for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's total sleep opportunity (TSO) window and computing sleep metrics within that window."}, {'measure': 'Cohort B: Percentage of Time Asleep During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "The percentage of time asleep for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window."}, {'measure': 'Cohort B: Number of Wake Bouts During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Number of wake bouts for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window."}, {'measure': 'Cohort B: Sleep Onset Latency During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Sleep onset latency which is time to transition from full wakefulness to sleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window."}, {'measure': 'Cohort B: Wake After Sleep Onset During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Wake after sleep onset is time for which participants were awake after having initially fallen asleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window."}, {'measure': 'Cohort B: Total Scratch Duration During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Total scratch duration for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window."}, {'measure': 'Cohort B: Total Scratch Episodes During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': "Total scratch episodes for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window."}, {'measure': 'Cohort B: Number of Available Minutes During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': 'Available minutes represented any recorded accelerometer data per day per device in minutes. Number of available minutes for GENEActiv and Panoramic Bracelet was derived by the in-house built Sci-kit Digital Health (SKDH) package.'}, {'measure': 'Cohort B: Number of Minutes of Wear During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': 'Number of minutes of wear include the total number of minutes the device is worn including sleep time and awake time. The wear time parameter (number of minutes of wear) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.'}, {'measure': 'Cohort B: Number of Wear Minutes While Awake During the At-Home Period', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv', 'description': 'The wear time parameter (number of wear minutes while awake) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.'}, {'measure': 'Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7', 'timeFrame': 'Day 7', 'description': 'Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicated more comfort, except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.'}, {'measure': 'Cohort A: Number of Days to Complete Enrollment', 'timeFrame': 'Up to approximately 8 months', 'description': 'Number of days to complete enrollment corresponded to the total number of days it took to enroll all study participants within the age groups of 3-5 years, 6-11 years and 12-17 years.'}], 'secondaryOutcomes': [{'measure': 'Cohort A: Number of Participants Enrolled Over Time', 'timeFrame': 'Up to approximately 8 months', 'description': 'Number of participants enrolled at specified month intervals in the study is reported in this outcome measure.'}, {'measure': 'Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Number of participants who were able to perform each of the 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.'}, {'measure': 'Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks)', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Percentage of tasks completed from a total of 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.'}, {'measure': 'Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days)'}, {'measure': 'Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days)'}, {'measure': 'Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device', 'timeFrame': 'From Day 1 to Day 15 (+ 3 days)'}, {'measure': 'Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1', 'timeFrame': 'Day 1', 'description': 'Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.'}, {'measure': 'Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation', 'timeFrame': 'Day 15 (+ 3 days)', 'description': 'Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.'}, {'measure': 'Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Single limb support time referred to the time when only one limb was in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Swing time was defined as the time during which the foot was not in contact with the ground. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Cadence referred to the number of steps taken per minute during gait cycle. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Gait speed was the time taken to walk a specified distance. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride duration refers to the duration between successive heel contacts of the same foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.'}, {'measure': 'Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home', 'timeFrame': 'From Day 1 up to Day 7'}, {'measure': 'Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}, {'measure': 'Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}, {'measure': 'Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}, {'measure': 'Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}, {'measure': 'Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}, {'measure': 'Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}, {'measure': 'Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}, {'measure': 'Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}, {'measure': 'Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks', 'timeFrame': 'Up to 20 minutes on Day 1', 'description': 'Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\\*3) wearing Panoramic bracelet device and APDM devices at participant\'s natural speed and at varied speeds. Natural speed was participant\'s self-chosen pace for 3 rounds. Varied speeds included participant\'s self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer\'s algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['COHORT A :', 'Gait', 'Activity', 'Actigraphy', 'COHORT B:', 'Sleep'], 'conditions': ['Child, Preschool', 'Child', 'Adolescent']}, 'referencesModule': {'references': [{'pmid': '38514860', 'type': 'DERIVED', 'citation': 'Di J, Tuttle PG, Adamowicz L, Lin W, Zhang H, Psaltos D, Selig J, Bai J, Karahanoglu FI, Sheriff P, Seelam V, Williams B, Ghafoor S, Demanuele C, Santamaria M, Cai X. Monitoring Activity and Gait in Children (MAGIC) using digital health technologies. Pediatr Res. 2024 Aug;96(3):750-758. doi: 10.1038/s41390-024-03147-x. Epub 2024 Mar 21.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=X9001263', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'COHORT A: To study whether a digital health tool called Actigraph can be used to collect information on gait and physical activity in healthy children aged 3-17. The study will be conducted at the Pfizer Innovation Research Laboratory (PfIRe Lab) in Cambridge MA. In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. Children will wear 2 Actigraph devices, one as a watch and one as a belt. They will then go home and do usual daily activities while answering a brief daily activity diary for approximately 2 weeks. The conclusion of the study will be over the telephone and include questions on the comfort and wearability of the device. The analysis of gait and physical activity as well as adherence and wearability will be looked across three different age groups 3-5, 6-11, and 12-17.\n\nCOHORT B: Cohort B of the study aims to evaluate the feasibility of the Panoramic Bracelet and associated algorithms such as SleepPy and GaitPy compared to the GENEActiv device and to evaluate the comfort and wearability of the Panoramic Bracelet. The results of this study will enable the use of novel devices in future clinical trials measuring scratch and sleep. . In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. They will then go home and do usual daily activities while wearing both devices in the same wrist at different times stipulated in the protocol, answering a brief daily activity and sleep diary for approximately 2 weeks. Cohort B includes questions on the comfort and wearability of the Panoramic device on Day 7 approximately. The conclusion of the study will be over the telephone.The analysis will be looked across three different age groups 3-5, 6-11, and 12-17'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy children and adolescents aged 3-17.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ambulatory\n* No significant health problems that would impair the completion of the physical activity tasks, does not carry any diagnosis of developmental delay and/or significant co-morbid medical conditions as determined by a medically qualified individual during medical history review\n\nExclusion Criteria:\n\n* Participation in other studies involving digital devices within 1 week and/or treatment with an investigational drug (Phases 1-4) within 30 days or 5 half-lives before the current study begins and/or during study participation.\n* Participants with implanted medical devices.\n* Minor participants who reach the age of majority during the study, as recognized under local law.\n* Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Participants with known allergies to components as specified by device manufacturer if applicable (eg, plastic, stainless steel and silicone)."}, 'identificationModule': {'nctId': 'NCT04823650', 'acronym': 'MAGIC', 'briefTitle': 'Monitoring Activity And Gait In Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Low-Interventional Study to Record Gait and Physical Activity Using ActiGraph Devices in Children Ages 3-17.', 'orgStudyIdInfo': {'id': 'X9001263'}, 'secondaryIdInfos': [{'id': 'MAGIC', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ages 3-5', 'description': 'COHORT A and B', 'interventionNames': ['Device: COHORT A: Actigraph', 'Device: Panoramic Bracelet and GENEActiv']}, {'label': 'Ages 6-11', 'description': 'COHORT A and B', 'interventionNames': ['Device: COHORT A: Actigraph', 'Device: Panoramic Bracelet and GENEActiv']}, {'label': 'Ages 12-17', 'description': 'COHORT A and B', 'interventionNames': ['Device: COHORT A: Actigraph', 'Device: Panoramic Bracelet and GENEActiv']}], 'interventions': [{'name': 'COHORT A: Actigraph', 'type': 'DEVICE', 'description': 'The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.', 'armGroupLabels': ['Ages 12-17', 'Ages 3-5', 'Ages 6-11']}, {'name': 'Panoramic Bracelet and GENEActiv', 'type': 'DEVICE', 'description': 'Panoramic Bracelet:\n\nThe Panoramic Digital Health Bracelet is a wearable inertial measurement unit "intended for use by researchers and healthcare professionals for high frequency or continuous collection of physical data in home and professional healthcare settings during research studies." It includes a 3 axis accelerometer and gyroscope, as well as magnetometer, pressure, and temperature sensors. The bracelet has no interface or screen for participants to interact with.\n\nGENEActiv:\n\nThe GENEActiv device is a wearable inertial measurement unit "designed for public health research and clinical trials." The device is a circular unit with attachable wrist-bands, and has no interface or screen for participants to interact with. The GENEActiv device is FDA 510(k) exempt. The device records acceleration data and can collect data remotely for up to 1 month.', 'armGroupLabels': ['Ages 12-17', 'Ages 3-5', 'Ages 6-11']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02139', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Innovation Research, PfIRe, Lab', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}