A Study on the Effectiveness of Upper Extremity Rehabilitation Training Using Brain-Machine Interface Biofeedback in Stroke Patients With Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change of Fugl Meyer Assessment-Upper Limb (FMA-UL) Score
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of upper extremity rehabilitation using a Brain-Machine Interface (BMI) in individuals with hemiplegia due to stroke. The main questions it aims to answer are:
- Can BMI-assisted occupational therapy improve the Fugl Meyer Assessment-Upper Limb (FMA-UL) score in chronic stroke participants?
- How does the effectiveness of BMI-assisted occupational therapy compare to conventional occupational therapy alone?
Participants will:
Undergo 5 sessions of BMI-assisted occupational therapy in phase 1. Be randomly allocated to either a control group (receiving conventional occupational therapy) or an experimental group (receiving BMI-assisted OT plus conventional OT) in phase 2.
Researchers will compare the control group (OT plus OT) and the experimental group (BMI-assisted OT plus OT) to see if there is a significant difference in the change of FMA-UL score between the two groups.
详细描述
This is a study to evaluate the efficacy of upper extremity rehabilitation using Brain-Machine Interface (BMI) on individuals with hemiplegia due to stroke. BMI is a device that can record and analyze human brain signals (in this study Functional near-infrared spectroscopy was used) and also provide live feedback (by pneumatic glove movement) to the individual wearing it. This device hypothetically enables more accurate training by reinforcing the correctly activated brain signal repeatedly then conventional therapy.
In phase 1 study investigators will evaluate the feasibility of BMI on chronic stroke participants. 5 sessions of BMI-assisted occupational therapy (OT) will be performed and the Fugl Meyer Assessment-Upper Limb (FMA-UL) score change between the pre-treatment and post-treatment will be analyzed by paired t-test.
In phase 2 study, a randomized controlled study will be performed by randomly allocating participants to either control (OT plus OT) or experimental group (BMI-assisted OT plus OT) and the difference of FMA-UL score change between the two groups will be analyzed by Student's t-test.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Impossible to mask participants and care providers due to using a device that is so obvious.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subcortical stroke with hemiplegia
- •1st stroke
- •Time since onset is less than 3 months
- •Brunnstrom stage 2,3
排除标准
- •Recurred stroke
- •MMSE score below 10
- •Unstable medical condition
- •Pregnancy
- •Cannot sustain sitting position for 30 minutes
- •Pain that limits upper extremity exercise
研究组 & 干预措施
Conventional OT + Motor Imagery OT
Conventional OT (30 minutes/day) plus Motor Imagery OT (30 minutes/day) for 10 days.
干预措施: Motor imagery OT (Other)
Conventional OT + BMI-assisted Motor Imagery OT
Conventional OT (30 minutes/day) plus BMI-assisted motor imagery OT (30 minutes/day) for 10 days.
干预措施: BMI-assisted motor imagery OT (Device)
结局指标
主要结局
Change of Fugl Meyer Assessment-Upper Limb (FMA-UL) Score
时间窗: Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).
Impairment measurement
次要结局
- Change of Finger Tapping Test Score (taps/minute)(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).)
- Change of Finger Extension (Metarcapophalangeal [MCP] joint) Range of Motion (degree)(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).)
- Change of Hand grasp power (lb)(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).)
- Change of Brunnstrom Stage(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).)
- Change of muscle strength (Medical Research Council)-Upper extremity(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).)
- Change of Box and Block Test (BBT) Score (boxes/60 second)(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).)
- Change of Functional near-infrared spectroscopy Connectivity(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).)
- Change of Modified Ashworth Scale (MAS) of upper extremity(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).)
- Change of range of motion of finger extension (degrees) measured with Camera and marker(Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).)
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital