Status:
COMPLETED
Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Scoliosis Research Society
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10+ years
Phase:
NA
Brief Summary
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).
Detailed Description
The study has been completed.
Eligibility Criteria
Inclusion
- Diagnosis of AIS
- Age ≥10 years
- Risser sign 0-2
- 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
- History of treatment of AIS
- \>= 1 year postmenarchal (for girls only)
- Physical or mental disability to adhere to bracing
- Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
- Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
- Difficulty to read, understand, and complete the study questionnaires
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00989495
Start Date
October 1 2008
End Date
November 1 2011
Last Update
December 3 2014
Active Locations (1)
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1
The Duchess of Kent Children's Hospital
Hong Kong, China