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

NCT07112911 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-09-12

No results posted yet for this study

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

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 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.

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 during this phase. During the OT training, the stroke participants will perform functional daily living tasks, including cylindrical grasp, disc grasp, and tip pinch.

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 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.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Xiaoling HU · The Hong Kong Polyterchnic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2026-02-27
Completion
2026-04-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07112911 on ClinicalTrials.gov