Restoring Functional Capacity of the Upper Extremity Using Combined Neuromuscular Electrical Stimulation Robot and Trans-Spinal Electrical Stimulation in Individuals With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 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 clinical efficacy and neurological progress of combined training using trans-spinal electrical stimulation (tsES) and neuromuscular electrical stimulation (NMES)-driven robotics on upper limb rehabilitation after stroke
详细描述
This study aims to explore whether a multimodal intervention that combines central neuromodulation through trans-spinal electrical stimulation (tsES), peripheral activation via neuromuscular electrical stimulation (NMES), and task-specific robotic training can enhance upper limb recovery.
Specific objectives:
- To evaluate the clinical efficacy of combining tsES and NMES robotic training for enhancing upper limb motor function in post-stroke patients.
- To quantify the neurological progress of the tsES and NMES robot combined interventions in the rehabilitation process using electrophysiological tracers (electroencephalogram, electromyogram) and kinesiological recorder (Inertial Measurement Unit)
- To investigate the central-to-peripheral neuroplasticity by corticomuscular coherence evaluation in poststroke rehabilitation
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects in the chronic stage (start from 6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic);
- •Sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score>23);
- •Be able to sit up for 60 minutes (with or without assistance);
- •Muscle strength graded from 1 to 3 in biceps brachii, triceps brachii, extensor carpi radialis, flexor carpi radialis, and abductor pollicis brevis in the affected side.
- •The voluntary electromyographic signals of the wrist extensor and wrist flexor muscle groups can be detected.
排除标准
- •Patients with secondary stroke;
- •Severe dysphasia (either expressive or comprehensive) with inadequate communication;
- •Any additional medical or psychological condition affecting their ability to comply with the study protocol;
- •History of other neurological disease, psychiatric disorder, including alcoholism and substance abuse;
- •currently pregnant;
- •epilepsy;
- •pacemaker implantation or deep brain stimulation;
- •involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb;
- •skin disease at the area of the electrodes;
- •High hypertension and cannot maintain normal blood pressure despite daily intake of antihypertensive medication.
研究组 & 干预措施
tsES-ENMS rehabilitation
The stroke participants will receive trans-spinal electrical stimulation (tsES), peripheral activation via neuromuscular electrical stimulation (NMES), and task-specific upper limb robotic training. A mobile hybrid neuromuscular electrical stimulation (NMES)-robot, i.e., exoneuromusculoskeleton (ENMS) was adopted in the experiment.
干预措施: Electrical Stimulation; Rehabilitation Robot (Device)
tsES-OT rehabilitation
The stroke participants will receive a task-oriented occupational therapy(OT), along with trans-spinal electrical stimulation (tsES) rehabilitation.
干预措施: Occupational Therapy with Electrical Stimulation (Behavioral)
sham tsES-OT rehabilitation
The stroke participants will receive a task-oriented occupational therapy, along with sham trans-spinal electrical stimulation (tsES) rehabilitation.
干预措施: occupational therapy with sham electrical stimulation (Behavioral)
结局指标
主要结局
Change in Fugl-Meyer Assessment Scale after training
时间窗: Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training
The Fugl-Meyer Assessment (FMA) Scale for the upper limb measures voluntary motor function in the shoulder, wrist, and hand. The total score ranges from 0 to 66, with higher scores indicating better motor function. The scale can be further divided into two subscores: shoulder/elbow (0-42) and wrist/hand (0-24).
次要结局
- Change in Modified Ashworth Scale(MAS), Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT) after training(Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training)
- Change in Cortico-Muscular Coherence (CMC) after training(Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training)
研究者
Xiaoling Hu
Director of Research Postgraduate Studies and Associate Professor
The Hong Kong Polytechnic University