Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
NCT ID: NCT00989495
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2008-10-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Brace - Randomized
Participants were randomized to be braced
Brace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
Observation - Randomized
Participants were randomized to be observed only
No interventions assigned to this group
Brace - preference based
Participants chose to be braced
Brace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
Observation - preference-based
Participants chose to be observed only
No interventions assigned to this group
Interventions
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Brace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
Eligibility Criteria
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Inclusion Criteria
2. Age ≥10 years
3. Risser sign 0-2
4. 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
Exclusion Criteria
2. \>= 1 year postmenarchal (for girls only)
3. Physical or mental disability to adhere to bracing
4. Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
5. Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
6. Difficulty to read, understand, and complete the study questionnaires
7. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
10 Years
ALL
No
Sponsors
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Scoliosis Research Society
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Dr Daniel Yee Tak FONG
Associate Professor
Principal Investigators
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Daniel YT Fong, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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The Duchess of Kent Children's Hospital
Hong Kong, , China
Countries
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Other Identifiers
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HKCTR-819
Identifier Type: REGISTRY
Identifier Source: secondary_id
dytfong
Identifier Type: -
Identifier Source: org_study_id