Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recommend exercise - perference exercise | Active Comparator |
| |
| recommend exercise - perference brace | Active Comparator |
| |
| recommend exercise - perference observation | No Intervention | ||
| recommend brace - perference brace | Active Comparator |
| |
| recommend brace - perference exercise | Active Comparator |
| |
| recommend brace - perference observation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Exercise rehabilitation with Schroth method |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the age and the out-of-control rate of treatment | Correlation between the patient's age and the out-of-control rate of treatment | 36 months |
| Correlation between the BMI at baseline and the out-of-control rate of treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaoyin Jiang, MD | Contact | +8689868603821 | Jiangdoctor1979@sina.com | |
| Zhenyu Wang, Ph.D | Contact | +8613391281688 | drwang@vip.qq.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital | Recruiting | Haikou | Hainan | 570300 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D001915 | Braces |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brace | Device | Wear an orthopedic brace |
|
| 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 |
Correlation between the patient's BMI (kg/m^2) at baseline and the out-of-control rate of treatment
| 36 months |
| Correlation between the type of AIS and the out-of-control rate of treatment | Correlation between the type of AIS and the out-of-control rate of treatment | 36 months |
| Correlation between the types of braces and the out-of-control rate of treatment | Correlation between the types of braces and the out-of-control rate of treatment | 36 months |
| Correlation between the average time spent doing homework per day at baseline and the out-of-control rate of treatment | Correlation between the average time (hours) spent doing homework per day at baseline and the out-of-control rate of treatment | 36 months |
| Correlation between the vitamin D content at baseline and the out-of-control rate of treatment | Correlation between the serum 25(OH)D (nmol/L) at baseline and the out-of-control rate of treatment | 36 months |
| Correlation between the average time spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment | Correlation between the average time (hours) spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment | 36 months |
| Correlation between the age and the change in 36-month Cobb angle from baseline | Correlation between the patient's age and the change in 36-month Cobb angle from baseline | 36 months |
| Correlation between the BMI at baseline and the change in 36-month Cobb angle from baseline | Correlation between the patient's BMI (kg/m^2) at baseline and the change in 36-month Cobb angle from baseline | 36 months |
| Correlation between the type of AIS and the change in 36-month Cobb angle from baseline | Correlation between the type of AIS and the change in 36-month Cobb angle from baseline | 36 months |
| Correlation between the types of braces and the change in 36-month Cobb angle from baseline | Correlation between the types of braces and the change in 36-month Cobb angle from baseline | 36 months |
| Correlation between the average time spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline | Correlation between the average time (hours) spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline | 36 months |
| Correlation between the vitamin D content at baseline and the change in 36-month Cobb angle from baseline | Correlation between the serum 25(OH)D (nmol/L) at baseline and the change in 36-month Cobb angle from baseline | 36 months |
| Correlation between the average time spent doing outdoor exercise after school per day at baseline and the change in 36-month Cobb angle from baseline | Correlation between the average time (hours) spent doing outdoor exercise after school per day at baseline and the change in 36-month Cobb angle from baseline | 36 months |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |