Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-30 @ 5:25 AM
Study NCT ID:
NCT00989495
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001915', 'term': 'Braces'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2009-10-01', 'studyFirstSubmitQcDate': '2009-10-02', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.', 'timeFrame': 'Baseline and every four months'}], 'secondaryOutcomes': [{'measure': 'SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.', 'timeFrame': 'Baseline and every four months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AIS'], 'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).', 'detailedDescription': 'The study has been completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of AIS\n2. Age ≥10 years\n3. Risser sign 0-2\n4. Cobb's angle 20 deg to \\<25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to \\<30 deg\n\nExclusion Criteria:\n\n1. History of treatment of AIS\n2. \\>= 1 year postmenarchal (for girls only)\n3. Physical or mental disability to adhere to bracing\n4. Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature\n5. Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)\n6. Difficulty to read, understand, and complete the study questionnaires\n7. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol"}, 'identificationModule': {'nctId': 'NCT00989495', 'briefTitle': 'Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study', 'orgStudyIdInfo': {'id': 'dytfong'}, 'secondaryIdInfos': [{'id': 'HKCTR-819', 'type': 'REGISTRY', 'domain': 'Hong Kong Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brace - Randomized', 'description': 'Participants were randomized to be braced', 'interventionNames': ['Device: Brace']}, {'type': 'NO_INTERVENTION', 'label': 'Observation - Randomized', 'description': 'Participants were randomized to be observed only'}, {'type': 'EXPERIMENTAL', 'label': 'Brace - preference based', 'description': 'Participants chose to be braced', 'interventionNames': ['Device: Brace']}, {'type': 'NO_INTERVENTION', 'label': 'Observation - preference-based', 'description': 'Participants chose to be observed only'}], 'interventions': [{'name': 'Brace', 'type': 'DEVICE', 'description': 'Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day', 'armGroupLabels': ['Brace - Randomized', 'Brace - preference based']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': "The Duchess of Kent Children's Hospital", 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Daniel YT Fong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scoliosis Research Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr Daniel Yee Tak FONG', 'investigatorAffiliation': 'The University of Hong Kong'}}}}