NCT07705256招募中不适用
Pilot Study of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Upper Extremity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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 >
- •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
研究组 & 干预措施
Visual EMG feedback with vibrotactile feedback
Experimental
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.
干预措施: Visual EMG feedback with vibrotactile feedback (Device)
Visual EMG feedback
Active Comparator
Participants in the control group will receive visual EMG feedback only and will complete the same assessment schedule as the intervention group.
干预措施: Visual EMG feedback (Device)
结局指标
主要结局
Fugl-Meyer Upper Extremity
时间窗: Baseline, Interim (Day 11), End (Day 16), 1-Week after the end if the intervetnion, 1-Month Follow-up, 6-Month Follow-up
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.
次要结局
- The Action Arm Research Test(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(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(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.)
- Motor Activity Log(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.)
- Hospital Anxiety and Depression Scale(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(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(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(For acute/subacute participants, the questionnaire is listed at 1 week post-stroke.)
- TMS assessment(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(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(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.)
- Edinburgh Handedness Inventory(Baseline for all patients)
- EuroQol instrument(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(From enrollment up to 8 weeks)
- Electroencephalography assessment(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(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.)
研究者
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