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Not Yet Recruiting NCT07705256

EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation

Conditions: Stroke, Spinal Cord Injuries (Complete and Incomplete)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Imperial College London

Location: Charing Cross Hospital London

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.

Eligibility Criteria

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 \ 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07705256). StuddyBuddy aggregates publicly available trial information.