EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Visual EMG feedback with vibrotactile feedback
DeviceSurface 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
DeviceThe 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Visual EMG feedback with vibrotactile feedbackExperimental treatment 1 intervention
Group B: Visual EMG feedbackActive comparator 1 intervention
Trial outcomes
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-upSecondary 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-up2
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.Sponsors and contacts
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Source ClinicalTrials.gov