Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-05 @ 5:35 PM
Study NCT ID:
NCT04638595
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2020-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Normative Movement Analysis Data Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Create normative baseline data for typically developing children', 'timeFrame': '1 year', 'description': 'Establishing a baseline of pediatric biomechanics is an important step in performing the best possible analyses for our patients. Normative data provides that baseline, and provides the data to explore links within the dense, interconnected behavior of human motion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric ALL']}, 'descriptionModule': {'briefSummary': "The objective of this project is to collect baseline data from a normative population of children that gender and age matches the population of patients expected to be treated by Mary Bridge Children's Therapy Services and seen in the Research and Movement Laboratory. This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age. Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A group of 50 neurotypical pediatric subjects will be recruited for this data collection. Children will be assigned to 1 of 5 age groupings (3-5, 6-8, 9-11, 12-14, 15-18), with an equal amount of male/female in each.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 3-18 years\n* Ambulate independently and without the use of assistive devices\n* Perform activities of daily living without physical assistance\n* Tolerate adhesive markers placed on skin and clothing\n* Willing and interested in participating\n\nExclusion Criteria:\n\n* Neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues\n* Evidence of developmental delays, muscle weakness, decreased muscle tone, joint stiffness, muscle or bone deformity\n* Currently using or has a history of using assistive technology devices, bracing/orthoses, manual or powered mobility equipment\n* Was born pre-term\n* Currently or has a history of taking medication or pharmaceutical treatment related to musculoskeletal side-effects/scenario/diagnosis'}, 'identificationModule': {'nctId': 'NCT04638595', 'briefTitle': 'Pediatric Normative Movement Analysis Data Collection', 'organization': {'class': 'OTHER', 'fullName': 'MultiCare Health System Research Institute'}, 'officialTitle': 'Pediatric Normative Movement Analysis Data Collection', 'orgStudyIdInfo': {'id': 'Normative Data Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normative', 'description': '50 neurotypical pediatric subjects', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age. Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.', 'armGroupLabels': ['Normative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': "Mary Bridge Children's Therapy Unit", 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MultiCare Health System Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}