Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke
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
- Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
研究概览
简要总结
The goal of this randomized controlled trial is to determine whether using both brain and muscle signals to control a wrist-hand rehabilitation robot can improve recovery in people with chronic stroke.
A total of 48 participants will be randomly assigned to one of two groups. Both groups will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton rehabilitation robot.
In the closed-loop sensorimotor integrated group, the system will use information from both brain-muscle coordination and muscle activity to recognize the participant's movement intention and provide electrical stimulation and robotic assistance. In the electromyography-driven group, the system will use muscle activity alone to control the electrical stimulation and robotic assistance.
The main questions this study aims to answer are:
Does control using both brain and muscle signals improve wrist and hand motor function more than control using muscle signals alone? Does this approach produce greater changes in coordination between the brain and muscles? Participants will complete motor-function and brain-muscle assessments before training, immediately after the 20 training sessions, and 3 months after training.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. at least 6 months after the onset of a unilateral lesion due to stroke;
- •2. moderate to severe motor disability in the paretic wrist-hand joints (6\21);
- •6. aged from 30 to 70 years.
排除标准
- •currently pregnant;
- •dysphasia (language deficiency);
- •skull implantation;
- •post-stroke neglect;
- •pacemaker implantation;
- •involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb;
- •the overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).
研究组 & 干预措施
Closed-Loop Sensorimotor Integrated Group
Participants will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton (ENMS). In this group, corticomuscular coherence (CMC) and electromyographic (EMG) signals will be used together to identify voluntary movement intention and control neuromuscular electrical stimulation and robotic assistance during wrist and hand movements.
干预措施: CSMI-Controlled ENMS (Device)
EMG-Driven Group
Participants will receive 20 sessions of wrist-hand rehabilitation using the same exoneuromusculoskeleton (ENMS). In this group, electromyographic (EMG) activity alone will be used to identify voluntary movement intention and control neuromuscular electrical stimulation and robotic assistance during wrist and hand movements.
干预措施: EMG-Driven ENMS (Device)
结局指标
主要结局
Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
时间窗: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
The Fugl-Meyer Assessment Wrist and Hand Subscore (FMA-WH) evaluates motor impairment of the paretic wrist and hand after stroke. The score ranges from 0 to 24, including a maximum of 10 points for wrist function and 14 points for hand function. Higher scores indicate better wrist-hand motor function.
次要结局
- Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)(At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training)
- Wrist Spasticity Assessed by the Modified Ashworth Scale (MAS)(At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training)
- Elbow Spasticity Assessed by the Modified Ashworth Scale (MAS)(At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training)
- Fugl-Meyer Assessment Shoulder/Elbow Subscale Score(At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training)
- Action Research Arm Test (ARAT) Score(At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training)
研究者
Xiaoling Hu
Associate professor
The Hong Kong Polytechnic University