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

NCT07112911 | Active Not Recruiting DMC

• 1 other identifier: HSEARS20250520004
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment Scale after 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).

  Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training

Secondary Outcomes (2)

• 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

Study Arms (3)

tsES-ENMS rehabilitation

EXPERIMENTAL

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.

Device: Electrical Stimulation; Rehabilitation Robot

tsES-OT rehabilitation

ACTIVE COMPARATOR

The stroke participants will receive a task-oriented occupational therapy(OT), along with trans-spinal electrical stimulation (tsES) rehabilitation.

Behavioral: Occupational Therapy with Electrical Stimulation

sham tsES-OT rehabilitation

SHAM COMPARATOR

The stroke participants will receive a task-oriented occupational therapy, along with sham trans-spinal electrical stimulation (tsES) rehabilitation.

Behavioral: occupational therapy with sham electrical stimulation

Interventions

Electrical Stimulation; Rehabilitation Robot DEVICE

The recruited subjects will receive 20 sessions of robot-assisted upper limb training combined with central-to-peripheral electrical stimulation, delivered at a frequency of 3 to 5 sessions per week, which will be completed within 4 to 7 consecutive weeks. Each rehabilitation session will begin with a 10-minute preparation phase, followed by 20 minutes of NMES and tsES-assisted robotic training. After a 10-minute break, the session will continue with an additional 20 minutes of robotic-assisted training combined with NMES alone, with tsES turned off during this phase. During the training, patients will perform repeated wrist and finger flexion-extension tasks. The training protocol is designed to activate wrist extension voluntarily (exceeding 10% of their initial MVC), which then triggers NMES and inflation of the robotic hand to assist finger opening.

tsES-ENMS rehabilitation

Occupational Therapy with Electrical Stimulation BEHAVIORAL

The recruited subjects will receive 20 sessions of task-oriented occupational therapy(OT) combined with trans-spinal electrical stimulation(tsES), delivered at a frequency of 3 to 5 sessions per week, which will be completed within 4 to 7 consecutive weeks. Each rehabilitation session will begin with a 10-minute preparation phase, followed by 20 minutes of OT training with tsES. After a 10-minute break, the session will continue with an additional 20 minutes of COT alone, with tsES turned off during this phase. During the OT training, the stroke participants will perform functional daily living tasks, including cylindrical grasp, disc grasp, and tip pinch.

tsES-OT rehabilitation

occupational therapy with sham electrical stimulation BEHAVIORAL

The recruited subjects will receive 20 sessions of task-oriented occupational therapy(OT) combined with sham trans-spinal electrical stimulation(tsES), delivered at a frequency of 3 to 5 sessions per week, which will be completed within 4 to 7 consecutive weeks. Each rehabilitation session will begin with a 10-minute preparation phase, followed by 20 minutes of OT training with 0mA-intensity tsES. After a 10-minute break, the session will continue with an additional 20 minutes of COT alone, with tsES turned off during this phase. During the training, the stroke participants will repeatedly practice functional daily living tasks, including cylindrical grasp, disc grasp, and tip pinch.

sham tsES-OT rehabilitation

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Electric Stimulation; Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Xiaoling HU

  The Hong Kong Polyterchnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Postgraduate Studies and Associate Professor

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: July 28, 2025
• Primary Completion: February 27, 2026
• Study Completion: April 30, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

CN (1)