Effectiveness of Full-Time Prophylactic Bracing at Preventing or Delaying Curve Progression in Paralytic Scoliosis Secondary to Spinal Cord Injury in the Growing Child: Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 6
- 主要终点
- X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis.
研究概览
简要总结
The purpose of this study is to determine whether full-time high dose prophylactic bracing (23 hours or more per day) is more effective than low dose bracing (12 hours or less per day) in preventing or delaying spinal curve progression in children with scoliosis after spinal cord injury.
详细描述
This is a randomized control trial to determine the effectiveness of high dose bracing (≥ 23 hours per day) and low dose bracing (≤ 12 hours per day) in skeletally immature children with Spinal Cord Injury. Subjects will be randomized into either a prophylactic high dose-bracing group (≥ 23 hours per day) or low dose-bracing group (≤ 12 hours per day). Subjects will be stratified by age (younger than age 10 and older than age 10), and curve severity (< 20 degrees and 20-40 degrees) using a matching random blocks design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with C5 to L2 SCI.
- •ASIA impairment levels A, B, or C.
- •Age greater than 5 up to one year before end of growth (14 in girls, 16 in boys)
- •A single structural curve <40 degrees or a double curve <40 degrees where the largest compensatory curve is <25 degrees on bending film.
- •Children at risk for Paralytic Scoliosis
- •Ability to follow simple instructions.
排除标准
- •Curve magnitude >40 degrees, pressure sores over the trunk.
- •Inability to tolerate TLSO wears.
- •Structural compensatory curves of 25 degrees or greater (double structural curves).
- •Severe Traumatic Brain Injury, TBI (8 and below on Glasgow Coma Scale).
- •Cognitive Impairment
- •Less than 6 months from date of injury
结局指标
主要结局
X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis.
时间窗: 5 years
Timed Motor Assessment (at the time of consent and once a year for 5 years) to measure functional ability in daily life activities including putting on sweat pants, T-Shirt, transferring from wheelchair to bed, etc.
时间窗: 5 years
Reachable Workspace Assessment (at the time of consent and once a year for 5 years): performing functional tasks including reaching for the floor, overhead, and every 20-degree radius in between.
时间窗: 5 years
Global Measures (at the time of consent and every 6 months for 5 years): Four different questionnaires to monitor function, satisfaction, and quality of life.
时间窗: 5 years
次要结局
未报告次要终点