Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-01 @ 1:47 AM
Study NCT ID:
NCT03589612
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2018-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-07-05', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Popliteal Angle Test', 'timeFrame': '5 minute', 'description': 'The Popliteal Angle Test was used to assess hamstring flexibility. Child asked to rise lower leg straight. Incomplete angle degree of full extension is popliteal angle.'}], 'secondaryOutcomes': [{'measure': '6 Minute Walk Test', 'timeFrame': '6 minute', 'description': '6 Minute Walk Test was used to assess performance with children Duchenne MUscular Dystropy.'}, {'measure': 'North Star Ambulation Assessment', 'timeFrame': '20 minute', 'description': 'The North Star Ambulatory Assessment (NSAA) is used to assess mobility for in ambulatory children with DMD for 5 years. NSAA is consist of 17 items from stand to run.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Duchenne Muscular Dystrophy', 'performance', 'hamstring flexibility', 'regression'], 'conditions': ['Duchenne Muscular Dystrophy', 'Performance', 'Flexibility']}, 'descriptionModule': {'briefSummary': 'Investigator investigated that regression of hamstring flexibility and performance in children with Duchenne Muscular Dystrophy.', 'detailedDescription': 'Flexibility of hamstrings was evaluated by Popliteal Angle test. Performance was evaluated 6 Minute Walk Test (6 MWT). Regression of hamstring flexibility and performance was examined regression tests. Correlation was examined between popliteal angle test and parameter of North Star Ambulation Assessment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sixty children will participated this study. Fourty-two children was assessed, and eighteen children will assess in a few months.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be a Duchenne Muscular Dystrophy diagnosis,\n* Being in the ambulatory period and climbing four steps independently,\n* to be Level 1 and Level 2 according to Brooke Lower Functional Classification Test\n* To be able to cooperate\n* No any severe contracture in the lower limbs which may prevent assessments,\n\nExclusion Criteria:\n\n* Children who fail to meet these criteria study.'}, 'identificationModule': {'nctId': 'NCT03589612', 'briefTitle': 'Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy', 'orgStudyIdInfo': {'id': 'GO 16/740-2'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Sıhhiye', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Güllü Aydın, Msc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Numan Bulut, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'İpek Gürbüz, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Ayşe Karaduman, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Oznur Yılmaz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Lütfiye AKKURT, PT', 'investigatorAffiliation': 'Hacettepe University'}}}}