Neuromuscular Mechanisms of Specific Trunk Interventions in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Trunk Control Measurement Scale (TCMS) score from baseline.
研究概览
简要总结
Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.
详细描述
We will determine whether repeat exposure to pelvis perturbation during sitting astride will induce functional improvements in trunk postural control and locomotion in children with CP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax.
- •Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training.
- •Subjects will be able to remain seated without help for ≥10s.
- •GMFCS levels will be I to IV.
- •Children must be able to signal pain, fear or discomfort reliably.
- •Children with mild scoliosis (Cobb angle < 20 °).
- •Children with CP who have no prior hippotherapy experiences within 6 months.
排除标准
- •severe lower extremity contractures, fractures, osseous instabilities, osteoporosis.
- •severe disproportional bone growth.
- •unhealed skin lesions in the lower extremities.
- •thromboembolic diseases, cardiovascular instability.
- •aggressive or self-harming behaviors.
结局指标
主要结局
Change in Trunk Control Measurement Scale (TCMS) score from baseline.
时间窗: baseline, post 6 weeks of training and 8 weeks after the end of training.
The maximum value for the total TCMS is 58 points (no unit). Specifically, there is 20 points for the category 'static sitting balance', 28 points for 'selective movement control', and 10 points for 'dynamic reaching'). A higher TCMS scores indicates a better motor performance in trunk control.
次要结局
- Chang in 6-minute walking distance from baseline(baseline, post 6 weeks of training and 8 weeks after the end of training.)
- Change in Walking speed from baseline(baseline, post 6 weeks of training and 8 weeks after the end of training.)
- Change in GMFM-66(baseline, post 6 weeks of training and 8 weeks after the end of training.)
研究者
Ming Wu
Research Scientist
Shirley Ryan AbilityLab