NCT03208439Unknown不适用
Interactive Cycling System Using Electromyography (EMG)-Driven Neuromuscular Electrical Stimulation (NMES) for Rehabilitation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Lower-Extremities Fugl-Meyer Assessment
研究概览
简要总结
A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
- •sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
- •significant gait deficit (Functional Ambulatory Category, FAC, scale <4 [person cannot walk independently]).
排除标准
- •any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression;
- •severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
- •implanted cardiac device (e.g. pacemaker and internal defibrillator).
研究组 & 干预措施
EMG-driven NMES
Experimental
subjects will receive EMG-driven NMES cycling exercise.
干预措施: lower-limb cycling system (Device)
passive pre-programmed NMES
Placebo Comparator
subjects will receive passive pre-programmed NMES during cycling exercise.
干预措施: lower-limb cycling system (Device)
结局指标
主要结局
Lower-Extremities Fugl-Meyer Assessment
时间窗: 3-month follow up
次要结局
- Berg Balance Scale(3-month follow up)
- electroencephalography(3-month follow up)
- 10-Meter Walk Test(3-month follow up)
- Elderly Mobility Scale(3-month follow up)
- 6-Minute Walking Test(3-month follow up)
研究者
Raymond KY Tong
Professor
Chinese University of Hong Kong
研究点 (1)
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