Effects of Combined Neuromuscular Electrical Stimulation Robot and Trans-Spinal Electrical Stimulation in Poststroke Rehabilitation

Not Applicable

Active, not recruiting

• Conditions: Stroke

• Registration Number: NCT07112911
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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

Detailed Description

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:

1. To evaluate the clinical efficacy of combining tsES and NMES robotic training for enhancing upper limb motor function in post-stroke patients.

2. 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)

3. To investigate the central-to-peripheral neuroplasticity by corticomuscular coherence evaluation in poststroke rehabilitation

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-28
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2026-02-27
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• (1) 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); (2) Sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score>23); (3) Be able to sit up for 60 minutes (with or without assistance); (4) 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. (5) The voluntary electromyographic signals of the wrist extensor and wrist flexor muscle groups can be detected.

Exclusion Criteria

• (1) Patients with secondary stroke; (2) Severe dysphasia (either expressive or comprehensive) with inadequate communication; (3) Any additional medical or psychological condition affecting their ability to comply with the study protocol; (4) History of other neurological disease, psychiatric disorder, including alcoholism and substance abuse; 4) currently pregnant; 5) epilepsy; 6) pacemaker implantation or deep brain stimulation; 7) involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb; 8) skin disease at area of electrodes; 9) High hypertension and cannot maintain normal blood pressure despite daily intake of antihypertensive medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Assessment Scale 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	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).

Secondary Outcome Measures

Name	Time	Method
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	The Modified Ashworth Scale (MAS) assesses muscle spasticity by measuring resistance during passive joint movement, particularly in the flexor muscles. The MAS consists of six levels, ranging from 0 to 4 (with an additional grade of 1+), where higher scores indicate increased resistance and greater muscle spasticity.; The Action Research Arm Test (ARAT) evaluates upper limb motor function by measuring the ability to perform specific tasks related to grasp, grip, pinch, and gross movement. It consists of 19 items, each scored from 0 to 3, with a total score ranging from 0 to 57. Higher scores represent better upper limb functional performance.; The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability through a series of timed and functional tasks. It includes 15 function-based items and 2 strength-based items. Each task is timed and rated on a 6-point functional ability scale, where higher scores and faster completion times reflect better motor performance.
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	Cortico-Muscular Coherence (CMC) is calculated using simultaneous EEG and EMG recordings to assess the functional connectivity between the motor cortex and the target muscle.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇨🇳 Hong Kong, China