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

Official title

Restoring Functional Capacity of the Upper Extremity Using Combined Neuromuscular Electrical Stimulation Robot and Trans-Spinal Electrical Stimulation in Individuals With Chronic Stroke

Overview

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

Interventions

• Device Electrical Stimulation; Rehabilitation Robot
  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
• Behavioral Occupational Therapy with Electrical Stimulation
  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 du
• Behavioral occupational therapy with sham electrical stimulation
  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

Primary outcome measures

• Change in Fugl-Meyer Assessment Scale after training [Time frame: Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training]

Secondary outcome measures (2)

• Change in Modified Ashworth Scale(MAS), Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT) after training [Time frame: 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 [Time frame: Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Hong Kong · 2 centers

• The Hong Kong Polytechnic University — Hong Kong
• The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07112911 · HSEARS20250520004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗