Effectiveness and Feasibility of a Brain-computer Interface Based Neurofeedback System With Reduced Therapist Supervision for Hand Motor Recovery in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
研究概览
简要总结
Stroke is a leading cause of long-term disability, with 30-60% of survivors remaining unable to use their affected arms after discharge. Existing rehabilitation approaches such as motor imagery, robotic assistance, and neuromodulation have shown limited effectiveness for hand motor recovery. The Lifescapes system is a novel EEG-based brain-computer interface that combines motor imagery practice, biofeedback, neuromuscular electrical stimulation, and robotic assistance to help post-stroke patients with severe hand paralysis. A recent clinical trial in 40 patients demonstrated promising improvements in motor function with the Lifescapes system, supporting its potential as a rehabilitation tool.
This study aims to evaluate whether Lifescapes therapy delivered with reduced therapist supervision can improve upper-limb motor function in stroke patients, and whether such an approach is operationally feasible in the local clinical setting.
32 participants will be recruited from Alexandra Hospital and National University Hospital over 2 years.
Participants must be aged 21-80, have had a stroke between 8 weeks and 5 years before enrolment, and have moderate to severe upper-limb impairment. They must be able to give informed consent and follow instructions. Participants are excluded if they are pregnant, have bilateral stroke, severe finger spasticity (MAS >2), implanted stimulators or pacemakers, recent seizures within 90 days, or any unstable medical conditions.
Participants will complete 16 sessions of Lifescapes BCI training over 4-8 weeks (2-4 sessions per week, approximately 30 minutes each). Therapist assistance will be progressively reduced based on each participant's ability, though a therapist remains present throughout. Each Lifescapes session is followed by a 30-minute GRASP session, a standardised self-directed arm and hand exercise programme prescribed by an occupational therapist.
Participants will attend up to 21 visits over 5-6 months. Outcomes are assessed at 6 timepoints: pre-baseline (2-4 weeks before starting), baseline, after the 8th session, after the 16th session, and at 1-month and 3-month follow-up (the latter optional). Outcome measures include the Fugl-Meyer Assessment for the upper extremity (FMA-UE), Action Research Arm Test (ARAT), grip and pinch strength, Modified Ashworth Scale (MAS), Motor Activity Log-14 (MAL-14), EQ-5D-5L quality of life measure, and optional TMS measurement of corticospinal excitability.
详细描述
Background
Stroke is a leading cause of adult long-term disability, with 30-60% of stroke survivors remaining unable to use their affected arms after discharge. While many interventional approaches have been tested - including motor imagery, robotic movement assistance, and neuromodulation - therapeutic efficacy remains limited for hand motor function. The Lifescapes system is a novel EEG-based brain-computer interface (BCI) neurofeedback system that facilitates motor imagery practice in post-stroke patients with severe hemiparesis, integrating biofeedback, neuromuscular electrical stimulation (NMES), and robot-aided sensorimotor stimulation. By triggering NMES and robotic assistance contingent on sensorimotor rhythm event-related desynchronisation (SMR-ERD) magnitude, the system enables voluntary modulation of endogenous sensorimotor activities in the ipsilesional hemisphere. A recent RCT in 40 chronic post-stroke hemiplegic patients demonstrated a significant between-group difference in Fugl-Meyer Assessment scores in favour of the Lifescapes group, supporting its potential as an adjunctive rehabilitation approach.
Study Objectives
The primary objective is to evaluate the effectiveness of Lifescapes therapy with reduced therapist supervision in improving upper-limb motor function in sub-acute and chronic stroke patients with moderate to severe upper limb paresis. The secondary objective is to evaluate the operational feasibility of Lifescapes with reduced therapist supervision in the local context. It is hypothesised that Lifescapes therapy with reduced therapist supervision is feasible in this study population and will quantitatively improve hand motor function.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-80 years old;
- •First-ever or recurrent ischemic or haemorrhagic stroke;
- •Stroke onset between 8 weeks and 5 years prior to enrolment;
- •Moderate to severe unilateral upper-limb motor impairment following stroke, defined as a baseline upper-extremity Fugal-Meyer Assessment (FMA-UE) score <47, and Manual Muscle Testing (MMT) of finger extensor ≤2;
- •Being able to provide informed consent, understand and follow verbal instructions.
- •Having sufficient visual acuity to scan full computer screen.
排除标准
- •Pregnant or breastfeeding women;
- •Bilateral stroke;
- •Modified Ashworth Scale (MAS) of finger flexors >2;
- •Use of a pacemaker or of other implanted stimulators;
- •History of seizures within 90 days before enrolment;
- •Impossible to record EEG because of skin status or skull deformity;
- •Sensorimotor disturbance due to other causes other than stroke;
- •Medically unstable or uncontrolled conditions that may compromise safety or the ability to complete scheduled visits.
研究组 & 干预措施
MI-BCI training with NMES and robotic movement assistance
Eligible subjects will undergo 16 sessions of MI-BCI training with NMES and robotic movement assistance using the paralyzed hand through the Lifescapes device.
干预措施: Lifescapes (Device)
结局指标
主要结局
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
时间窗: Week 0 (Pre-baseline assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
时间窗: Week 2 (baseline assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
时间窗: Week 5 (Interim-intervention assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
时间窗: Week 8 (Post-intervention assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
时间窗: Week12 (1 month after the intervention)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
时间窗: Week 20 (3 months after the intervention)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
次要结局
- Action Research Arm Test (ARAT)(Week 0 (Pre-baseline assessment))
- Action Research Arm Test (ARAT)(Week 2 (baseline assessment))
- Action Research Arm Test (ARAT)(Week 5 (Interim-intervention assessment))
- Action Research Arm Test (ARAT)(Week 8 (Post-intervention assessment))
- Action Research Arm Test (ARAT)(Week12 (1 month after the intervention))
- Action Research Arm Test (ARAT)(Week 20 (3 months after the intervention))
- Grip and pinch strength(Week 0 (Pre-baseline assessment))
- Grip and pinch strength(Week 2 (baseline assessment))
- Grip and pinch strength(Week 5 (Interim-intervention assessment))
- Grip and pinch strength(Week 8 (Post-intervention assessment))
- Grip and pinch strength(Week12 (1 month after the intervention))
- Grip and pinch strength(Week 20 (3 months after the intervention))
- Modified Ashworth Scale (MAS)(Week 0 (Pre-baseline assessment))
- Modified Ashworth Scale (MAS)(Week 2 (baseline assessment))
- Modified Ashworth Scale (MAS)(Week 5 (Interim-intervention assessment))
- Modified Ashworth Scale (MAS)(Week 8 (Post-intervention assessment))
- Motor Activity Log-14 (MAL-14)(Week 12 (1 month after the intervention))
- Motor Activity Log-14 (MAL-14)(Week 20 (3 months after the intervention))
- EQ5D(Week 0 (Pre-baseline assessment))
- EQ5D(Week 2 (baseline assessment))
- EQ5D(Week 5 (Interim-intervention assessment))
- EQ5D(Week 8 (Post-intervention assessment))
- EQ5D(Week12 (1 month after the intervention))
- EQ5D(Week 20 (3 months after the intervention))
- Corticospinal Excitability measurement by TMS- Motor threshold(Week 0 (Pre-baseline assessment))
- Corticospinal Excitability measurement by TMS- Motor threshold(Week 2 (baseline assessment))
- Corticospinal Excitability measurement by TMS- Motor threshold(Week 5 (Interim-intervention assessment))
- Corticospinal Excitability measurement by TMS- Motor threshold(Week 8 (Post-intervention assessment))
- Corticospinal Excitability measurement by TMS- Motor threshold(Week12 (1 month after the intervention))
- Corticospinal Excitability measurement by TMS- Motor threshold(Week 20 (3 months after the intervention))
- System Usability Scale (SUS)(Week 8 (Post-intervention assessment))
- MoCA(Week 0 (Pre-baseline assessment))