Biomechatronic System Using Voluntary Motor Effort (VME)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment Scale after training
研究概览
简要总结
The purpose of this study is to investigate the combined training effectiveness of mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The recruited subjects will
- •have unilateral ischemic brain injury or intracerebral hemorrhage at least 6 months after the onset of single stroke
- •have moderate level of motor impairment in the affected upper limb, assessed by Fugl-Meyer Assessment (9<shoulder/elbow<27; 6<wrist/hand<18)
- •have enough cognition to be able to follow the training protocol as assessed by Mini-metal State Examination (MMSE>21)
- •have detectable EMG signals (3 times of the standard deviation above the baseline) from the upper limb muscles.
排除标准
- 未提供
结局指标
主要结局
Change in Fugl-Meyer Assessment Scale after training
时间窗: 1) up to 7 weeks, 2) 3 months after participants finish the training
The Fugl-Meyer Assessment Scale for upper limb measures the voluntary motor function on the shoulder, the elbow, the wrist and hand. The full score ranges from 0 to 66. It can be further separated into two subscores, i.e., shoulder/elbow (0-42) and wrist/hand (0-24). The higher the score, the better is the related motor function.
Change in Modified Ashworth Scale after training
时间窗: 1) up to 7 weeks, 2) 3 months after participants finish the training
The Modified Ashworth Scale measures the resistance of a joint during passive motion, which indicates the muscle spasticity related to the joint motion, particularly the flexors. The Modified Ashworth Scale has six levels, i.e., 0, 1, 1+, 2, 3, 4. The higher value is related to a higher joint resistance, i.e., higher muscle spasticity.
次要结局
未报告次要终点
研究者
Xiaoling Hu
Doctor
The Hong Kong Polytechnic University