Screening and Intervention for AIS in Haikou, Hainan Province, China

Study Overview
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Brief Summary
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This is a single-center, prospective, non-randomized, open-label, interventional, real-world study. The mild/moderate AIS patients will be recruited through screening of 250,000 primary and secondary school students in Haikou, Hainan Province. The patients will be treated with different non-surgical interventions (exercise intervention or brace intervention) according to the physician's recommendations and the patient's intention. Patients will be followed up for 36 months to evaluate the effectiveness and safety of non-surgical interventions in the real world.

Official Title
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Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China

Conditions
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AIS

Intervention / Treatment
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* Behavioral: Exercise
* Device: Brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 9 years ≤ age ≤ 16 years Diagnosis of AIS 10°≤Cobb's angle<45° Signed informed consent form Exclusion Criteria: With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders Obvious deformity of lower limbs and(or) feet Previous or ongoing treatment of AIS Difficulty to read, understanding, and complete the study questionnaires Any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 16 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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: recommend exercise - perference exercise<br> | Behavioral: Exercise<br>* Exercise rehabilitation with Schroth method<br>|
| Active Comparator: recommend exercise - perference brace<br> | Device: Brace<br>* Wear an orthopedic brace<br>|
| No Intervention: recommend exercise - perference observation<br> | |
| Active Comparator: recommend brace - perference brace<br> | Device: Brace<br>* Wear an orthopedic brace<br>|
| Active Comparator: recommend brace - perference exercise<br> | Behavioral: Exercise<br>* Exercise rehabilitation with Schroth method<br>|
| No Intervention: recommend brace - perference observation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Out-of-control rate of treatment | Among the patients with skeletal immaturity (Risser's sign 0, 1, 2), out-of-control rate of treatment at the follow-up to 36 months or at skeletal maturity during the trial (i.e., 4° for female Risser's sign or 5° for male Risser's sign). Out-of-control rate of treatment is defined as either: Cobb angle progression >5°, or Cobb angle ≥45°, or the physician recommends or already has enhanced the intervention regimen (i.e., no intervention change to exercise intervention, no intervention change to brace intervention, or exercise intervention change to brace intervention). | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SRS-22 score from baseline over time | Change in quality of life (SRS-22 score) from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment | at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment | 
| Change in vital capacity from baseline over time | Change in vital capacity from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment. | at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment | 
| Change in plantar pressure from baseline over time | Change in plantar pressure from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months after treatment compared with those before treatment. | at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment | 
| Change in gait from baseline over time | Change in gait from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment | at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment | 
| Correlation between the treatment compliance and the out-of-control rate of treatment | Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the out-of-control rate of treatment | 36 months | 
| Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment | Correlation between the skeletal maturity (Risser's sign) at baseline and the out-of-control rate of treatment | 36 months | 
| Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment | Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment | 36 months | 
| Correlation between the immediate correction and the out-of-control rate of treatment | Correlation between the immediate correction [(the baseline of Cobb angle - Cobb angle immediately after wearing the brace)/the baseline of Cobb angle] and the out-of-control rate of treatment | 36 months | 
| The incidence of adverse events | The incidence of adverse events for the intervention | 36 months | 
| The change in Cobb angle from baseline over time | The change in Cobb angle from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment | 36 months | 
| Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline | Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the change in 36-month Cobb angle from baseline | 36 months | 
| Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline | Correlation between the skeletal maturity (Risser's sign) at baseline and the change in 36-month Cobb angle from baseline | 36 months | 
| Correlation between the immediate correction and the change in 36-month Cobb angle from baseline | Correlation between the immediate correction [(the baseline of Cobb angle - Cobb angle immediately after wearing the brace)/the baseline of Cobb angle] and the change in 36-month Cobb angle from baseline | 36 months | 
| Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline | Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline | 36 months |