Pilot of EMG-Directed VR Experience for Motor Stroke Rehabilitation
Research type
Research Study
Full title
Pilot of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation
IRAS ID
294830
Contact name
Paul Bentley
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Design: An interventional study conducted in both acute stroke patients and chronic stroke patients, to validate the use of a virtual-reality based rehabilitation therapy. Data from the control group will be collected first (approximately 29 patients), to generate preliminary results. Following this, the intervention group data will be collected (approximately 29 patients) and compared to the control group. We will also complete a sub study using a similar design and recruitment number as the virtual reality intervention where we include functional electrical stimulation.
Aims: To validate the use of an EMG-based virtual reality interface for use in the rehabilitation of stroke patients. To determine if there are biomarkers present in the EMG data that can be used to predict and inform on patient recovery. Generating experimental evidence on how to optimise rehabilitation, according to cognitive load, motor task and force generation.
Outcome Measures: The primary end point outcome will be the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6months, controlled for baseline.
Additional outcome measures will include: The Action Arm Research Test (ARAT), Functional Independence Measure (FIM), Modified Rankin Scale (mRS), Hospital Anxiety and Depression Scale (HADS), Faces Pain Rating Scale (F-PRS), Stanford Fatigue Visual Numeric Scale (SFVNS), Patient Questionnaires (see Appendix), Device Recordings (EMG data, game performance metrics, exercise time).
Population: A convenience sample of 58 stroke survivors will be screened and consented by delegated health care practitioners (HCPs) or researchers (i.e. Co-Investigators (Co-Is)).Eligibility: Participants will be 18yrs or over, acute/sub-acute or chronic stroke survivors with UL impairment that resulted from the stroke, fitting inclusion criteria specified herewith.
Duration: Participants’ enrolment in the study will last up to 7months. The study recruitment phase will open for up to 24months. The overall research period, including analysis and write up is anticipated to last 43months.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
21/SC/0370
Date of REC Opinion
25 Jan 2022
REC opinion
Further Information Favourable Opinion