Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 6:14 PM
Study NCT ID:
NCT06628934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Gait Sensors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020754', 'term': 'Spinocerebellar Ataxias'}], 'ancestors': [{'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iSARA', 'timeFrame': '8 Years', 'description': 'Digital measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA).'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcome Measure of Ataxia (PROM-Ataxia)', 'timeFrame': '8 Years', 'description': 'Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The PROM-Ataxia is a 70-item assessment of physical, mental health, and activities of daily living, each scored on a 0-4 Likert scale. Scores are totaled.'}, {'measure': 'Activities-specific Balance Confidence (ABC) Scale', 'timeFrame': '8 Years', 'description': 'Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The ABC scale is a 16 item scale with a rating scale from 0 (no confidence) to 100 (complete confidence) in avoiding a fall. The score is determined by taking the average of all items.'}, {'measure': 'EQ-5D-5L', 'timeFrame': '8 Years', 'description': 'Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The EQ-5D-5L is a 5 item descriptive system to describe current mobility, self-case, usual activities, pain/discomfort, and anxiety/depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinocerebellar Ataxia']}, 'descriptionModule': {'briefSummary': 'This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of Spinocerebellar ataxia.', 'detailedDescription': 'Study participants will complete a neurological exam with sensors (iSARA exam) and three patient-reported questionnaires (PROM-Ataxia, ABC Scale, EQ-5D-5L). Participation will take about an hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of Ataxia Clinics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ataxia Group - Individuals who have a genetic-confirmation of SCA diagnosis and are able to sit or stand unassisted for 30 seconds and follow directions.\n* Healthy Control Group - Individuals who are able to sit or stand unassisted for 30 seconds and follow directions.\n\nExclusion Criteria:\n\n* Any other neurological or musculoskeletal disorder not attributed to the SCA that could affect balance, gait or voluntary movement.'}, 'identificationModule': {'nctId': 'NCT06628934', 'briefTitle': 'Wearable Gait Sensors', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Wearable Sensors for Quantitation of Impaired Gait and Balance', 'orgStudyIdInfo': {'id': 'IRB17-0253'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinocerebellar Ataxia', 'description': 'Individuals with genetically-confirmed diagnosis of SCA'}, {'label': 'Healthy Controls', 'description': 'Healthy Controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}