NCT01657994已完成不适用
Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Gross Motor Function Measure-66 using multiple baseline assessments
研究概览
简要总结
The purpose of this research study is to learn more about the usefulness of a physical therapy treatment that combines robot-assisted walking with electrical impulses that help to make muscles contract. This treatment is intended for children with cerebral palsy. Up to eleven children with cerebral palsy will receive up to 18 treatments and will have several evaluations before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GMFCS II, III, or IV cerebral palsy
- •5-12 years of age
- •meet safety criteria for robotic gait training (<300 lbs, intact skin, femoral length 21-47 cm, ability to follow simple instructions)
- •meet safety criteria for functional electrical stimulation (voluntary hip and knee muscle contraction, intact skin)
排除标准
- •planned major intervention during study period
- •contractures that interfere with upright stance
- •history of non-traumatic long bone fracture or clinically significant osteoporosis
- •significant concurrent illness
- •significant condition not typically associated with cerebral palsy
结局指标
主要结局
Change in Gross Motor Function Measure-66 using multiple baseline assessments
时间窗: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
次要结局
- Change in 10 meter walk(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
- Change in strength via myometry(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
- Change in Modified Ashworth Scale(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
- Change in Goniometry at the knee(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
- Change in Children's Assessment of Participation and Enjoyment(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
- Change in Observational Gait Scale(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
- Change in Canadian Occupational Performance Measure(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
- Change in 6 minute walk(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
- Change in Cerebral Palsy Quality of Life Questionnaire(4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment)
研究者
研究点 (2)
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