EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation
2026년 7월 14일 업데이트: Imperial College London
Pilot Study of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation
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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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London, 영국
- Charing Cross Hospital
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연락하다:
- Paul Bentley, PhD in Cognitive Neuroscience
- 전화번호: 00447969570854
- 이메일: p.bentley@imperial.ac.uk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Visual EMG feedback with vibrotactile feedback
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.
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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.
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활성 비교기: Visual EMG feedback
Participants in the control group will receive visual EMG feedback only and will complete the same assessment schedule as the intervention group.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fugl-Meyer Upper Extremity
기간: Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up
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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.
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Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The Action Arm Research Test
기간: Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up
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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.
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Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up
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Functional Independence Measure
기간: 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.
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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" |
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.
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Chedoke Arm and Hand Activity Inventory
기간: 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.
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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.
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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.
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Motor Activity Log
기간: 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.
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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.
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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.
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Hospital Anxiety and Depression Scale
기간: 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
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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.
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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
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Faces Pain Rating Scale
기간: 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
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Faces pain scales consist of a series of line diagrams of faces with expressions of increasing distress.
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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
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Stanford Fatigue Visual Numeric Scale
기간: 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.
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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")
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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.
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Patient Questionnaire
기간: For acute/subacute participants, the questionnaire is listed at 1 week post-stroke.
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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 |
For acute/subacute participants, the questionnaire is listed at 1 week post-stroke.
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TMS assessment
기간: 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
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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.
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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
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Mini Mental State Exam
기간: 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.
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The MMSE is a paper-based test with a maximum score of 30, with lower scores indicating more severe cognitive problems.
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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.
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Montreal Cognitive Assessment
기간: 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.
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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.
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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.
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Edinburgh Handedness Inventory
기간: Baseline for all patients
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Short questionnaire for determining objectively whether one is left or right-handed.
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Baseline for all patients
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EuroQol instrument
기간: 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
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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.
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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
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EMG activity
기간: From enrollment up to 8 weeks
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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.
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From enrollment up to 8 weeks
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Electroencephalography assessment
기간: 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
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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
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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
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Re-admission Rate
기간: 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.
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Whether the patient has been required to return to hospital unexpectedly e.g.
second stroke, with a documented reason.
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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.
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 27일
기본 완료 (추정된)
2027년 5월 27일
연구 완료 (추정된)
2027년 11월 27일
연구 등록 날짜
최초 제출
2026년 7월 9일
QC 기준을 충족하는 최초 제출
2026년 7월 14일
처음 게시됨 (실제)
2026년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 14일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 168878
- 294830 (레지스트리 식별자: IRAS Project ID)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data (IPD) will not be shared with other researchers.
Study data will be stored securely and handled in accordance with the approved study protocol, participant consent, and applicable data protection requirements.
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아니
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