NCT04012125已完成不适用
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change of scoliosis
研究概览
简要总结
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GMFCS level III, IV, V of the Cerebral palsy
- •20-45 degree of Cobb's angle
排除标准
- •less than 20 degree or more than 45 degree of Cobb's angle
- •Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis
- •Acute lumbar pain
- •Fixed scoliosis
结局指标
主要结局
Change of scoliosis
时间窗: 6months
Cobb's angle in the whole spine anteroposterior view of X-ray, before and immediately after, and 6months after wearing FLEXpine brace
次要结局
- Pain of the back (thorax)(6 months)
- change of quality of life (aspect of the parents)(6 months)
研究者
Ju Seok Ryu
associate professor
Seoul National University Hospital
研究点 (2)
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