Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study

Not Applicable

Completed

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Device: Brace

• Registration Number: NCT00989495
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Primary Completion: 2011-03
• Study Completion: 2011-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Diagnosis of AIS
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

1. History of treatment of AIS
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brace - Randomized	Brace	Participants were randomized to be braced
Brace - preference based	Brace	Participants chose to be braced

Primary Outcome Measures

Name	Time	Method
Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.	Baseline and every four months

Secondary Outcome Measures

Name	Time	Method
SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.	Baseline and every four months

Trial Locations

Locations (1)

The Duchess of Kent Children's Hospital; 🇨🇳 Hong Kong, China