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

The Hong Kong Polytechnic University

Status: Active, not recruiting

Conditions: Stroke

Treatments: Device: Electrical Stimulation; Rehabilitation Robot; Behavioral: occupational therapy with sham electrical stimulation; Behavioral: Occupational Therapy with Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07112911

HSEARS20250520004

Details and patient eligibility

About

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

Full 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

Enrollment: 65 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 3 patient groups

tsES-ENMS rehabilitation

Experimental group

Description:

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.

Treatment:

Device: Electrical Stimulation; Rehabilitation Robot

tsES-OT rehabilitation

Active Comparator group

Description:

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

Treatment:

Behavioral: Occupational Therapy with Electrical Stimulation

sham tsES-OT rehabilitation

Sham Comparator group

Description:

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

Treatment:

Behavioral: occupational therapy with sham electrical stimulation