the Effectiveness of Brain-computer Interface-pedaling Training System on Motor and Cognitive Function Rehabilitation of Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The change of Fugl-Meyer motor function score of lower limbs
研究概览
简要总结
Stroke has become the first cause of death and disability among Chinese adults. 70%-80% of patients cannot live independently due to disability, which has brought a heavy burden to families, medical institutions and society. How to better evaluate and improve post-stroke motor and cognitive dysfunction has always been a hot research topic. With the rapid development of brain-computer interface technology, rehabilitation assessment based on quantitative EEG analysis is gradually being applied in the medical field. So we designed a brain-computer interface based on hierarchical task induction-pedaling rehabilitation training system to investigate the effectiveness on the rehabilitation of stroke patients.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-80 years old；
- •Patients with first ischemic stroke onset from 1 week to 3 months；
- •Hemiplegia and cognitive impairment (Mini-Mental State Examination (MMSE) score <28 or Montreal Cognitive Assessment (MoCA) <25)；
- •Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
- •The patient or its authorized agent signs the informed consent form.
排除标准
- •Severely impaired cognition, unable to pay attention to and understand screen information;
- •Severe pain and limited mobility of lower extremity.
研究组 & 干预措施
Brain-computer Interface-Pedaling Training System
干预措施: Brain-computer Interface-Pedaling Training System (Device)
Traditional Pedaling Training System
Patients wear the same EEG equipment that only collect data, but not guide training.
干预措施: Traditional Pedaling Training System (Device)
结局指标
主要结局
The change of Fugl-Meyer motor function score of lower limbs
时间窗: Two weeks after enrollment.
The score range is 0-34 points, the higher the score, the better the motor function of lower limb.
次要结局
- Attention index(Two weeks after enrollment.)
- Digital Span Test (DST)(Two weeks after enrollment.)
- Symbol Digit Modalities Test (SDMT)(Two weeks after enrollment.)