Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- GMFM-66, section E
研究概览
简要总结
The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor therapy on improvements of functional gait parameters in ambulatory children with cerebral palsy.
详细描述
Within a randomized controlled design the effects of robotic-assisted locomotor training (15 sessions within 5 weeks) will be examined in a sample of 34 children with cerebral palsy.
Children will be randomly assigned to an intervention or waiting list group. Assessments will be performed at baseline, in week 6 as well as in week 12. The intervention is provided to the waiting list group after the assessment in week 6.
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 (Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral spastic cerebral palsy
- •Gross Motor Function Classification Scale (GMFCS) II-IV
排除标准
- •Prior orthopedic surgery on the lower extremity or the trunk (<6 months)
- •Prior neurosurgical interventions (<6 months)
- •Significant mental retardation
- •Severe contractures
- •Prior Lokomat training (<6 months)
研究组 & 干预措施
Waiting list
Lokomat training after waiting phase of 5 weeks
干预措施: Lokomat training (Other)
Lokomat training
Lokomat training
干预措施: Lokomat training (Other)
结局指标
主要结局
GMFM-66, section E
时间窗: week 0, week 6, week 12
次要结局
- GMFM-66, section D(week 0, week 6, week 12)
- Gait speed(week 0, week 6, week 12)
- 6-minute walk test(week 0, week 6, week 12)
- 3D gait analysis(week 0, week 6)