EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation

July 14, 2026 updated by: Imperial College London

Pilot Study of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation

This study is testing whether rehabilitation using muscle activity signals can help improve arm and hand movement in people after stroke or spinal cord injury.

In the main study, participants will use a virtual-reality feedback system that is controlled by surface electromyography (EMG). Surface EMG uses sensors placed on the skin to detect muscle activity. The feedback will help participants practise upper limb movements during rehabilitation.

A related sub-study will run alongside the main study. In this sub-study, functional electrical stimulation will also be used to help activate muscles during training.

The study will assess whether these rehabilitation approaches improve upper limb function. It will also explore whether changes in biological or movement-related markers are linked with recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 or over
  • Cognitive status that would permit for use /supported use of intervention device and engagement in protocol related trainings/assessment. To be indicated by treating clinician at point of screening, formal capacity assessment to be conducted as appropriate. Refer to easy read patient information sheet (PIS) and training materials to support all patients presenting with specific cognitive and/or communication needs.
  • (We do not wish to exclude patients with cognitive impairment as this would limit the heterogeneity of our sample and generalizability of our findings, given the prevalence of cognitive impairment in stroke patients.)
  • Stroke diagnosis (can be first or subsequent stroke, unilateral haemorrhagic or ischemic) 2 weeks max post stroke at time of recruitment.
  • Can communicate in English, that is, sufficient for completion of intervention and outcome measures. A speech and language therapist (SLT) will be consulted if necessary to ensure all reasonable accommodations are made to support participation.
  • UL motor deficit post stroke (bilateral/unilateral) (according to National Institutes of Health Stroke Score (NIHSS) item 5), distal UL power <1 /5 on the Oxford Rating Scale (Medical Research Council Manual Muscle Testing scale).

Exclusion Criteria:

  • Patients already enrolled an interventional neuro rehabilitation trial.
  • Patients enrolled in clinical trials that contraindicate co-enrolment.
  • Patients presenting with unstable medical conditions/medical contraindications as determined by treating medical consultant (these patients may be approached at a later date should their condition improve).
  • Those registered blind/with uncompensated/uncorrected visual deficits, including severe neglect that prevents them from being able to focus on visually provided feedback.
  • Behavioural/affective dysfunction which could influence the ability of the person to engage with the research protocol and/or pose risk to the participating researchers (in circumstances such as follow-up community visits).
  • Other concomitant neurological disorders affecting upper extremity motor function (Multiple Sclerosis, Spinal Cord Injury, Brachial Plexus or Radial Nerve Injury).
  • Unremitting arm, wrist or hand pain at rest (Numeric Pain Rating Scale > 4). Consumption of caffeine 2 hours prior to assessment (assessment will be postponed to a later time).
  • Pre-existing UL impairment with known and significant disruption to range of motion, motor or functional performance (fracture, arthritic changes, other known musculoskeletal problems). Or pre-modified Rankin Score > 2.
  • Skin condition apparent on the ventral UE such that might place participant at risk of irritation in the context of repeated physical contact (such as that associated with the intervention).
  • Subsequent MRI that fails to confirm stroke
  • Chronic stroke patients whose stroke occurred in excess of 2.5 years ago
  • Patients whose cognitive impairment prevents them from following instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Visual EMG feedback with vibrotactile feedback
Participants in the intervention group will receive visual EMG feedback combined with vibrotactile/haptic feedback delivered through a wearable EMG-based device during attempted upper limb movements.
Device: Visual EMG feedback with vibrotactile feedback
Surface EMG sensors detect muscle activity and provide visual feedback. The device also delivers vibrotactile/haptic feedback in the form of vibrations during attempted upper limb movements.
Active Comparator: Visual EMG feedback
Participants in the control group will receive visual EMG feedback only and will complete the same assessment schedule as the intervention group.
Device: Visual EMG feedback
The intervention consists of visual EMG feedback through a wearable EMG-based device during attempted upper limb movements. Surface EMG sensors detect muscle activity and provide visual feedback.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper Extremity
Time Frame: Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up
3 categories, comprised of 22 sub questions scored on a 3-point ordinal scale (0=unable, 1=partial, 2=near normal). The sum of the categories ranges between 0 and 66 points (66 = normal function). The FM-UE has shown excellent inter-rater reliability (Sullivan et al., 2011)(Duncan et al., 1992) moderate to good responsiveness (Lundquist & Maribo, 2017) and good concurrent validity when compared with similar tests of arm motor functioning. MCID is 5 points.
Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Action Arm Research Test
Time Frame: Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up
The ARAT is an UL capacity test which assesses the ability to grasp, move and release objects of various sizes, weights and shapes. It has 19 sub questions scored on a 4- point ordinal scale, adding up to a total score between 0 and 57 points (57 = normal capacity). The MCID is set at 5.7 points, i.e., 10 % of the range.
Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up
Functional Independence Measure
Time Frame: For acute/subacute participants, MoCA will be collected at 3 months and 6 months post-stroke. For chronic participants, MoCA will be collected immediately post-recruitment, 3 months post-intervention, and 6 months post-intervention.

18-item measurement tool, of physical, psychological and social function. Tasks that are evaluated using the FIM include bowel and bladder control, transfers, locomotion, communication, social cognition as well as six self-care activities.

FIM scores range from 1 to 7. The grading categories range from "total assistance with helper = 1" to "complete independence with no helper=7"
For acute/subacute participants, MoCA will be collected at 3 months and 6 months post-stroke. For chronic participants, MoCA will be collected immediately post-recruitment, 3 months post-intervention, and 6 months post-intervention.
Chedoke Arm and Hand Activity Inventory
Time Frame: For acute/subacute participants, MoCA will be collected at 3 months and 6 months post-stroke. For chronic participants, MoCA will be collected immediately post-recruitment, 3 months post-intervention, and 6 months post-intervention.
The CAHAI tests patients' performance in completing 13 functional tasks involving arm/hand movement, and encouraging the use of bilateral function (e.g. opening a jar, pouring a glass of water, etc.). Each item is scored on a 7-point scale where a low score indicates that the patient needs more assistance and the paretic arm performs only a small amount of the task, while higher score indicates more independence for completion.
For acute/subacute participants, MoCA will be collected at 3 months and 6 months post-stroke. For chronic participants, MoCA will be collected immediately post-recruitment, 3 months post-intervention, and 6 months post-intervention.
Motor Activity Log
Time Frame: For acute/subacute participants, MoCA will be collected at 3 months and 6 months post-stroke. For chronic participants, MoCA will be collected immediately post-recruitment, 3 months post-intervention, and 6 months post-intervention.
This is a report-based assessment where patients are asked to rate their quality of movement and amount of the wearker arm movement during 30 (28 or 14 depending on the version) daily functional tasks. These tasks include object manipulation, and gross motor activities involving ambulation and balance. Patients are asked to score their quality of movement on a 6-item scale where a higher score indicates that the movements of this arm are closer to normal. Similarly their amount of use is scored out of 6 and a higher score refers to a use of the arm that is more similar to before the stroke.
For acute/subacute participants, MoCA will be collected at 3 months and 6 months post-stroke. For chronic participants, MoCA will be collected immediately post-recruitment, 3 months post-intervention, and 6 months post-intervention.
Hospital Anxiety and Depression Scale
Time Frame: Time frame for acute/subacute participants:3 weeks, 6 weeks, and 6 months post-stroke Time frame for chronic participants:Immediately post-recruitment, 3 weeks, 6 weeks, and 6 months post-intervention
14-item measure designed to assess anxiety and depression symptoms. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
Time frame for acute/subacute participants:3 weeks, 6 weeks, and 6 months post-stroke Time frame for chronic participants:Immediately post-recruitment, 3 weeks, 6 weeks, and 6 months post-intervention
Faces Pain Rating Scale
Time Frame: For acute/subacute participants, F-PRS will be collected at 1 week, 3 weeks, 6 weeks, 3 months, and 6 months post-stroke. For chronic participants, immediately post-recruitment, 1 week, 3 weeks, 6 weeks, 3 months, and 6 months post-intervention
Faces pain scales consist of a series of line diagrams of faces with expressions of increasing distress.
For acute/subacute participants, F-PRS will be collected at 1 week, 3 weeks, 6 weeks, 3 months, and 6 months post-stroke. For chronic participants, immediately post-recruitment, 1 week, 3 weeks, 6 weeks, 3 months, and 6 months post-intervention
Stanford Fatigue Visual Numeric Scale
Time Frame: For acute/subacute participants, S-FVNS will be collected at 1 week, 3 weeks, 6 weeks, 3 months, and 6 months post-stroke. For chronic participants, S-FVNS will be collected immediately post-recruitment, 1 week, 3 weeks, 6 weeks, 3 months, and 6 months.
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired")
For acute/subacute participants, S-FVNS will be collected at 1 week, 3 weeks, 6 weeks, 3 months, and 6 months post-stroke. For chronic participants, S-FVNS will be collected immediately post-recruitment, 1 week, 3 weeks, 6 weeks, 3 months, and 6 months.
Patient Questionnaire
Time Frame: For acute/subacute participants, the questionnaire is listed at 1 week post-stroke.

Questionnaire within qualitative interview to help us better understand some of the behavioural change components underlying acceptance of and adherence with the intervention.

See Semi-Structured Interview - Patient Questionnaire document
For acute/subacute participants, the questionnaire is listed at 1 week post-stroke.
TMS assessment
Time Frame: Time frame for acute/subacute participants :5 days, 3 weeks, and 6 months post-stroke. Time frame for chronic participants: 5 days, 3 weeks, and 6 months post-intervention
TMS can be used to assess the integrity of the cortico spinal tract and so will provide a useful measure of the level of functional impairment.
Time frame for acute/subacute participants :5 days, 3 weeks, and 6 months post-stroke. Time frame for chronic participants: 5 days, 3 weeks, and 6 months post-intervention
Mini Mental State Exam
Time Frame: For acute/subacute participants, MMSE will be collected at 6 months post-stroke. For chronic participants, MMSE will be collected immediately post-recruitment and 6 months post-intervention.
The MMSE is a paper-based test with a maximum score of 30, with lower scores indicating more severe cognitive problems.
For acute/subacute participants, MMSE will be collected at 6 months post-stroke. For chronic participants, MMSE will be collected immediately post-recruitment and 6 months post-intervention.
Montreal Cognitive Assessment
Time Frame: For acute/subacute participants, MoCA will be collected at 3 months and 6 months post-stroke. For chronic participants, MoCA will be collected immediately post-recruitment, 3 months post-intervention, and 6 months post-intervention.
The MoCA is a paper-based test with a maximum score of 30 points, with lower scores indicating more severe cognitive problems. It looks more in depth at some of the deficits and may be more sensitive to subtle cognitive deficits.
For acute/subacute participants, MoCA will be collected at 3 months and 6 months post-stroke. For chronic participants, MoCA will be collected immediately post-recruitment, 3 months post-intervention, and 6 months post-intervention.
Edinburgh Handedness Inventory
Time Frame: Baseline for all patients
Short questionnaire for determining objectively whether one is left or right-handed.
Baseline for all patients
EuroQol instrument
Time Frame: Time frame for acute/subacute participants: 3 weeks, 6 weeks, and 6 months post-stroke Time frame for chronic participants: Immediately post-recruitment, 3 weeks, 6 weeks, and 6 months post-intervention
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time frame for acute/subacute participants: 3 weeks, 6 weeks, and 6 months post-stroke Time frame for chronic participants: Immediately post-recruitment, 3 weeks, 6 weeks, and 6 months post-intervention
EMG activity
Time Frame: From enrollment up to 8 weeks
Recorded duration of time the device is in active use (per session/day/week- i.e. dose), number and type of gestures recorded (per session/day/week- i.e. intensity), time and date stamps affiliated with both. As well as the performance of the patient, as measured by the collected EMG activity and the performance on the games/activities that were engaged with, with metrics including completion rate, completion time, number of errors.
From enrollment up to 8 weeks
Electroencephalography assessment
Time Frame: Time frame for acute/subacute participants : 3 weeks and 6 months post-stroke Time frame for chronic participants: Immediately post-recruitment, 3 weeks, and 6 months post-intervention
EEG assessments can be useful in providing a measure of the cortical activity, which we can compare to the muscular activity detected in the limbs. The ratio of these variables could provide a useful biomarker of recovery
Time frame for acute/subacute participants : 3 weeks and 6 months post-stroke Time frame for chronic participants: Immediately post-recruitment, 3 weeks, and 6 months post-intervention
Re-admission Rate
Time Frame: For acute/subacute participants, readmission rate will be recorded at 6 months post-stroke. For chronic participants, readmission rate will be recorded at 6 months post-intervention.
Whether the patient has been required to return to hospital unexpectedly e.g. second stroke, with a documented reason.
For acute/subacute participants, readmission rate will be recorded at 6 months post-stroke. For chronic participants, readmission rate will be recorded at 6 months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 168878
  • 294830 (Registry Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers. Study data will be stored securely and handled in accordance with the approved study protocol, participant consent, and applicable data protection requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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