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

Study Overview
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Brief Summary
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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
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The study has been completed.

Official Title
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Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Device: Brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brace - Randomized<br>Participants were randomized to be braced | Device: Brace<br>* Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day<br>|
| No Intervention: Observation - Randomized<br>Participants were randomized to be observed only | |
| Experimental: Brace - preference based<br>Participants chose to be braced | Device: Brace<br>* Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day<br>|
| No Intervention: Observation - preference-based<br>Participants chose to be observed only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II. |  | Baseline and every four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIS