AIS
Conditions
Brief summary
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.
Interventions
BEHAVIORALExercise
Exercise rehabilitation with Schroth method
DEVICEBrace
Wear an orthopedic brace
Sponsors
Chaoyin Jiang
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. 9 years ≤ age ≤ 16 years 2. Diagnosis of AIS 3. 10°≤Cobb's angle\<45° 4. Signed informed consent form
Exclusion criteria
1. With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders 2. Obvious deformity of lower limbs and(or) feet 3. Previous or ongoing treatment of AIS 4. Difficulty to read, understanding, and complete the study questionnaires 5. Any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Out-of-control rate of treatment | 36 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SRS-22 score from baseline over time | at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment | 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 |
| Change in vital capacity from baseline over time | at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment | 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. |
| Change in plantar pressure from baseline over time | at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment | 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. |
| Change in gait from baseline over time | at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment | 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 |
| Correlation between the treatment compliance and the out-of-control rate of treatment | 36 months | Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the out-of-control rate of treatment |
| Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment | 36 months | Correlation between the skeletal maturity (Risser's sign) 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 Cobb's angle at baseline and the out-of-control rate of treatment |
| Correlation between the immediate correction and the out-of-control rate of treatment | 36 months | 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 |
| The incidence of adverse events | 36 months | The incidence of adverse events for the intervention |
| The change in Cobb angle from baseline over time | 36 months | 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 |
| Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline | 36 months | Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the change in 36-month Cobb angle from baseline |
| Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline | 36 months | Correlation between the skeletal maturity (Risser's sign) at baseline and the change in 36-month Cobb angle from baseline |
| Correlation between the immediate correction and the change in 36-month Cobb angle from baseline | 36 months | 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 |
| Correlation between the Cobb's angle at baseline 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the age and the out-of-control rate of treatment | 36 months | Correlation between the patient's age 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 type of AIS 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 types of braces and the out-of-control rate of treatment |
| Correlation between the average time spent doing homework per day at baseline and the out-of-control rate of treatment | 36 months | Correlation between the average time (hours) spent doing homework per day at baseline and the out-of-control rate of treatment |
| Correlation between the vitamin D content at baseline and the out-of-control rate of treatment | 36 months | Correlation between the serum 25(OH)D (nmol/L) at baseline and the out-of-control rate of treatment |
| Correlation between the average time spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment | 36 months | Correlation between the average time (hours) spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment |
| Correlation between the age and the change in 36-month Cobb angle from baseline | 36 months | Correlation between the patient's age and the change in 36-month Cobb angle from baseline |
| Correlation between the BMI 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 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 type of AIS 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 types of braces and the change in 36-month Cobb angle from baseline |
| Correlation between the average time spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline | 36 months | Correlation between the average time (hours) spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline |
| Correlation between the vitamin D content at baseline and the change in 36-month Cobb angle from baseline | 36 months | Correlation between the serum 25(OH)D (nmol/L) at baseline and the change in 36-month Cobb angle from baseline |
| 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 | 36 months | 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 |
| Correlation between the BMI at baseline and the out-of-control rate of treatment | 36 months | Correlation between the patient's BMI (kg/m\^2) at baseline and the out-of-control rate of treatment |
Countries
China
Contacts
Primary ContactChaoyin Jiang, MD
Backup ContactZhenyu Wang, Ph.D
Outcome results
None listed