Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 9:05 PM
Study NCT ID:
NCT01638169
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2012-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2012-07-09', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gait parameters', 'timeFrame': 'pre and post heels adj.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Step Time and Length', 'Symmetry', 'Step Time and Length Variability', 'Heart Rate', 'Gait Velocity']}, 'descriptionModule': {'briefSummary': 'During the stand phase the DMD foot is too plantarflexed in addition patients adopt a higher flexion and abduction of the hip in order to advance the swinging limb. The aim of this work is to assess the immediate contribution of heels for these walking disturbance in children with muscular dystrophy disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with DMD age \\>6 yrs walk without heel strike', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>6 yrs\n* walk without heel strike\n\nExclusion Criteria:\n\n* cannot understand simple instructions'}, 'identificationModule': {'nctId': 'NCT01638169', 'briefTitle': 'The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy', 'organization': {'class': 'OTHER', 'fullName': 'Alyn Pediatric & Adolescent Rehabilitation Hospital'}, 'orgStudyIdInfo': {'id': '920100239'}}, 'armsInterventionsModule': {'armGroups': [{'label': '20 children with DMD', 'interventionNames': ['Device: adding a heel']}], 'interventions': [{'name': 'adding a heel', 'type': 'DEVICE', 'description': 'walking with and without heels on the gaitrite system', 'armGroupLabels': ['20 children with DMD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90190', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Alyn', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alyn Pediatric & Adolescent Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}