Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-30 @ 6:30 AM
Study NCT ID:
NCT04483050
Status:
COMPLETED
Last Update Posted:
2022-11-25
First Post:
2020-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migration index', 'timeFrame': '6 months', 'description': 'Hip AP radiography'}], 'secondaryOutcomes': [{'measure': "Cobb's angle (')", 'timeFrame': '6 months', 'description': "using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value."}, {'measure': "Range of motion of hip joint (')", 'timeFrame': '6 months', 'description': "Using goniometer, measure the hip and knee abduction and flexion angle expressed by degree from 0' to 180'. The closer to 180', the better the value."}, {'measure': 'Visual analog scale', 'timeFrame': '6 months', 'description': 'measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.'}, {'measure': 'Likert scale (score)', 'timeFrame': 'immediately after wearing orthosis', 'description': 'measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.'}, {'measure': 'Child Health Index of Life with Disabilities (CPCHILD)', 'timeFrame': '6 months', 'description': 'measure the quality of life expressed by score from 0 to 100. The higher the quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 1 to 15\n* Patients with severe neuromuscular disease\n* Patients who agreed to participate in the study\n* Hip dislocation more than 10% (migration index)\n\nExclusion Criteria:\n\n* If do not agree with the study\n* Those who are determined to be difficult to participate under the judgment of the research director\n* History of hip joint surgery'}, 'identificationModule': {'nctId': 'NCT04483050', 'briefTitle': 'The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Open Label, Pilot Study', 'orgStudyIdInfo': {'id': 'B-2002/594-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Device: Hip protection orthosis']}], 'interventions': [{'name': 'Hip protection orthosis', 'type': 'DEVICE', 'description': 'Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Gyeonggi-do', 'state': 'Seongnam-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'overallOfficials': [{'name': 'Juseok Ryu, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea Health Industry Development Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ju Seok Ryu', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}