Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01390558
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2011-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2011-06-27', 'studyFirstSubmitQcDate': '2011-07-08', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait will be measured with the GaitRite gait evaluation system.', 'timeFrame': '3 years', 'description': 'Specific temporal and spatial parameters of gait will be measured with the GaitRite gait evaluation system. Subjects will walk with and without their orthotics. Measurement will be by changes in the previously noted gait parameters between the orthotics and non-orthotics groups.'}], 'secondaryOutcomes': [{'measure': 'Elucidate patterns in the development of walking in persons with Down Syndrome using GaitRite®.', 'timeFrame': '3 years', 'description': 'The previously described parameters of gait as measured by the GaitRite system will be used to establish an overview of the development of gait in persons with Down Syndrome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Down Syndrome', 'Orthotics', 'Gait Analysis'], 'conditions': ['Down Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a research study of persons with Down Syndrome between 2 and 80 years old who are independently walking. The purpose of this study is to see what effect orthotics have on how people with Down Syndrome walk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with Down Syndrome followed in Down Syndrome clinic Persons with Down Syndrome recruited in the community', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Down Syndrome, independent walkers\n\nExclusion Criteria:\n\n* Down Syndrome, not independently walking'}, 'identificationModule': {'nctId': 'NCT01390558', 'briefTitle': 'Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite', 'orgStudyIdInfo': {'id': 'Gait Parameters Down Syndrome'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persons with Down Syndrome who use orthotics', 'description': 'Orthotic users', 'interventionNames': ['Procedure: custom orthotics']}, {'label': 'Persons with Down Syndrome who do not use orthotics', 'description': 'Non orthotic users'}], 'interventions': [{'name': 'custom orthotics', 'type': 'PROCEDURE', 'description': 'Orthotics are fabricated uniquely for each patient and use molds or casts of their foot as the template. They are fabricated by a licensed orthotist. There is no device or brand name other than custom orthotics.', 'armGroupLabels': ['Persons with Down Syndrome who use orthotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Child Development and Rehabilitation Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David Oleson', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}