Therapeutic Effects of Robotic Exoskeleton-Assisted Gait Re-habilitation and Predictive Factors of Significant Improvements in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)
研究概览
简要总结
Investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. Investigators hypothesized that robotic assisted gait training brings better strength recovery and functional improvement.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged from 30 to 80 years
- •hemiparesis due to ischemic or hemorrhagic stroke in the last 6 months
排除标准
- •with a significant history of pain or injury of lower limbs that affected their walking ability,
- •with cardiopulmonary diseases that prohibited exercise training
- •with impaired cognitive function
- •unable to complete the timed up-and-go test
- •able to complete the timed up-and-go test in <20 seconds using walking device
结局指标
主要结局
Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)
时间窗: 4 weeks
Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)
时间窗: 4 weeks
Change from baseline scores in 12-item short form survey after entire rehabilitation program (4 weeks)
时间窗: 4 weeks
12-item short form survey (SF-12): scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)
时间窗: 4 weeks
tested by isokinetic dynamometer
次要结局
未报告次要终点