Prospective Study of Scoliosis in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Comparison of pre- and post- operative x-rays
研究概览
简要总结
This is a prospective, multi-centre study that will be looking at two groups of males and females over the course of their operative treatment for cerebral palsy (CP) scoliosis and the years following that treatment. The first group the study will be looking at is those individuals who undergo surgery for CP Scoliosis. The second group will be those individuals who do not undergo surgical treatment for CP Scoliosis, either because the family declines surgery or surgery is not recommended during the course of study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 8 and 18 years
- •Diagnosis of Cerebral Palsy with total body involvement
- •Coronal curve greater than 40 degrees OR a kyphotic curve greater than 50 degrees on sitting film will be included
- •Growing rod treatment will also be included
排除标准
- •Previous operated scoliotic spine deformity
- •Diagnosis of Rett's Syndrome
- •Concomitant lower extremity surgery (within 3 months of spinal fusion)
- •Cornelia de Lange Syndrome or any pervasive genetic disorder whose effects are due to much more than the static cortical injury
- •Ambulatory spastic diplegic without upper extremity impairment or speech, swallowing or other involvement
研究组 & 干预措施
Surgical Arm
Surgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon.
干预措施: Surgical fusion (Procedure)
Non-Surgical Arm
Non-Surgical No intervention - Includes patients who have either refused to have surgery or have not been recommended to have surgery at this point. These patients will continue to be monitored closely, however, will not receive any other intervention.
结局指标
主要结局
Comparison of pre- and post- operative x-rays
时间窗: 1 year
次要结局
- Gross motor function, physical data, past medical history, seizure status, pain and medications, sitting ability, activity level, clinical photos, quality of life questionnaires, data regarding surgery and hospital stay(1 year)