Instrumental Evaluation of Self-correction in Patients With Juvenile and Adolescent
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Self-correction measure
研究概览
简要总结
To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis.
The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction.
Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session.
Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •For both parts:
- •Patients with more than 2 scoliotic curves
- •Patients with secondary scoliosis
- •Patients suffering from learning disabilities or clinical conditions impairing neuromotor control
- •Patients lacking the necessary measures to evaluate the outcome.
- •Part 2 only (ultrasound)
- •● Patients undergoing brace treatment
结局指标
主要结局
Self-correction measure
时间窗: through study completion, an average of 6 months
The angular difference of the curves resulting from the detection with Scolioscan or Rx in the spontaneous position compared to what was obtained in the same condition but in the self-correcting position.
次要结局
未报告次要终点