StrokeNCT07112911
Effects of Combined Neuromuscular Electrical Stimulation Robot and Trans-Spinal Electrical Stimulation in Poststroke Rehabilitation
A study testing Electrical Stimulation; Rehabilitation Robot and Occupational Therapy with Electrical Stimulation in people with Stroke, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Electrical Stimulation; Rehabilitation Robot and Occupational Therapy with Electrical Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesHong Kong
- Study dates
- 28 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
XIAOLING Hu, PhD, 852-91601856, xiaoling.hu@polyu.edu.hk
XIAOLING Hu, PhD, 852-91601856, reefxlhu@gmail.com
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
XIAOLING Hu, PhD, 852-91601856, xiaoling.hu@polyu.edu.hk
XIAOLING Hu, PhD, 852-91601856, reefxlhu@gmail.com
About this study
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
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
Read the 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:
- To evaluate the clinical efficacy of combining tsES and NMES robotic training for enhancing upper limb motor function in post-stroke patients.
- 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)
- To investigate the central-to-peripheral neuroplasticity by corticomuscular coherence evaluation in poststroke rehabilitation
- Conditions
- Stroke
- Being tested
- Electrical Stimulation; Rehabilitation Robot, Occupational Therapy with Electrical Stimulation, occupational therapy with sham electrical stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Stimulation; Rehabilitation RobotDevice
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.
Occupational Therapy with Electrical StimulationBehavioural
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.
occupational therapy with sham electrical stimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: occupational therapy with sham electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start28 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Hu, The Hong Kong Polytechnic University
- Investigators
- Xiaoling HU, Principal investigator, The Hong Kong Polyterchnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112911
- Sponsor's protocol ID
- HSEARS20250520004
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07112911
- Acronym / sponsor ID
- HSEARS20250520004
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the clinical efficacy of combining tsES and NMES robotic training for enhancing upper limb motor function in post-stroke patients.
- 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)
- To investigate the central-to-peripheral neuroplasticity by corticomuscular coherence evaluation in poststroke rehabilitation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tsES-ENMS rehabilitation | Experimental | Device: Electrical Stimulation; Rehabilitation RobotThe 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. |
| tsES-OT rehabilitation | Active comparator | Behavioral: Occupational Therapy with Electrical StimulationThe stroke participants will receive a task-oriented occupational therapy(OT), along with trans-spinal electrical stimulation (tsES) rehabilitation. |
| sham tsES-OT rehabilitation | Sham comparator | Behavioral: occupational therapy with sham electrical stimulationThe stroke participants will receive a task-oriented occupational therapy, along with sham trans-spinal electrical stimulation (tsES) rehabilitation. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Stimulation; Rehabilitation RobotThe 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. | Device | tsES-ENMS rehabilitation |
| Occupational Therapy with Electrical StimulationThe 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. | Behavioural | tsES-OT rehabilitation |
| occupational therapy with sham electrical stimulationThe 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. | Behavioural | sham tsES-OT rehabilitation |
Primary outcome
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
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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoling HU principal investigator
The Hong Kong Polyterchnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation; Rehabilitation Robot and Occupational Therapy with Electrical Stimulation in people with Stroke, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.