EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation

NCT07705256 | Not Yet Recruiting

• 2 other identifiers: 168878294830
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Spinal Cord Injuries (Complete and Incomplete)

Keywords

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

Outcome Measures

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.

  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 (16)

• The Action Arm Research Test

  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

  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

  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

  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 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

Study Arms (2)

Visual EMG feedback with vibrotactile feedback

EXPERIMENTAL

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

Visual EMG feedback

ACTIVE COMPARATOR

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

Visual EMG feedback with vibrotactile feedback DEVICE

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.

Visual EMG feedback with vibrotactile feedback

Visual EMG feedback DEVICE

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.

Visual EMG feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Charing Cross Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): November 27, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)