ClinicalTrials.gg
RecruitingNCT07705256Updated Sep 9, 2026

EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation

An interventional study of Visual EMG feedback with vibrotactile feedback and Visual EMG feedback in Stroke and Spinal Cord Injuries (Complete and Incomplete), sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Imperial College London · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 19 studies in Stroke by Imperial College London — 2 open to participants now, 2 under way, none of them phase 3. Stroke · Imperial College London.

Planned enrollment
7th of 14
24 · median 24
Started
2026
the only one that year
No phase
10 of 19
1 open now
Registered
19th of 19
by date

Among the 19 studies in Stroke by Imperial College London, this one is the 7th largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2026, is one of 10 with no phase, and was the 19th registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.

Browse Stroke studies →

Open to participants now

2 of the 19 studies in Stroke by Imperial College London are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Stroke by Imperial College London, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Stroke
  • Spinal Cord Injuries (Complete and Incomplete)

Keywords

  • Stroke rehabilitation
  • upper limb rehabilitation
  • EMG biofeedback
  • motor recovery
  • neurorehabilitation
  • spinal cord injury rehabilitation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceVisual 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.

  • DeviceVisual 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.

06

What researchers measure

Primary outcomes

  1. Fugl-Meyer Upper Extremity

    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.

    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

Secondary outcomes

  1. The Action Arm Research Test

    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.

    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

  2. Functional Independence Measure

    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"

    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.

  3. Chedoke Arm and Hand Activity Inventory

    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.

    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.

  4. Motor Activity Log

    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.

    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.

  5. Hospital Anxiety and Depression Scale

    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: 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

  6. Faces Pain Rating Scale

    Faces pain scales consist of a series of line diagrams of faces with expressions of increasing distress.

    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

  7. Stanford Fatigue Visual Numeric Scale

    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")

    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.

  8. Patient Questionnaire

    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

    Time frame: For acute/subacute participants, the questionnaire is listed at 1 week post-stroke.

  9. TMS assessment

    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: 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

  10. Mini Mental State Exam

    The MMSE is a paper-based test with a maximum score of 30, with lower scores indicating more severe cognitive problems.

    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.

  11. Montreal Cognitive Assessment

    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.

    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.

  12. Edinburgh Handedness Inventory

    Short questionnaire for determining objectively whether one is left or right-handed.

    Time frame: Baseline for all patients

  13. EuroQol instrument

    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: 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. EMG activity

    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.

    Time frame: From enrollment up to 8 weeks

  15. Electroencephalography assessment

    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: 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

  16. Re-admission Rate

    Whether the patient has been required to return to hospital unexpectedly e.g. second stroke, with a documented reason.

    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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for May 2027, 9 months after the start.

Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 9 months is below that.

Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2026
First posted
Jul 15, 2026
StartActual
Aug 24, 2026
Primary completionEst.
May 27, 2027
CompletionEst.
Nov 27, 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07705256
Responsible party
Sponsor
First posted
Jul 15, 2026
Start date
Aug 24, 2026
Primary completion
May 27, 2027 (estimated)
Completion
Nov 27, 2027 (estimated)
Last update
Sep 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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