Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Out-of-control rate of treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •9 years ≤ age ≤ 16 years
- •Diagnosis of AIS
- •10°≤Cobb's angle<45°
- •Signed informed consent form
排除标准
- •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
结局指标
主要结局
Out-of-control rate of treatment
时间窗: 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).
次要结局
- Correlation between the treatment compliance 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(36 months)
- Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline(36 months)
- 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 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 gait from baseline over time(at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment)
- Correlation between the immediate correction and the out-of-control rate of treatment(36 months)
- Correlation between the treatment compliance 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(36 months)
- Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline(36 months)
- 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)
- The incidence of adverse events(36 months)
- Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment(36 months)
- The change in Cobb angle from baseline over time(36 months)
研究者
Chaoyin Jiang
Professor
Shanghai 6th People's Hospital