EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation

Imperial College London24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Spinal Cord Injuries (Complete and Incomplete)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * 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

Outcomes

Primary Outcomes

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

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

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.

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.

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.

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

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

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.

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.

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

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.

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.

Edinburgh Handedness Inventory

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

Time frame: Baseline for all patients

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

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

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

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.