Clinical Evaluation of a Brain-computer Interface Integrated With Plantar Pneumoorthoses for Motor and Cognitive Rehabilitation in Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Walking speed change as assessed by the 10-Meter Walk Test
研究概览
简要总结
STUDY PURPOSE The investigators are testing a new rehabilitation system that helps stroke patients recover their ability to walk and think more clearly. This system, called brain-computer interface with plantar pneumorthoses, uses brain signals to control a special device that provides gentle pressure to the feet, similar to what you feel when walking. The goal is to help patients regain walking skills, improve memory and thinking, and feel better emotionally.
STUDY QUESTIONS
The main questions the study aims to answer are:
Whether the investigated technology can improve walking in post-stroke patients? Whether the training to control the technology can improve cognitive function in post-stroke patients?
HOW THE STUDY WORKS The investigators compare two groups - one using the new system, another group receiving standard rehabilitation therapy.
Up to 15 patients will try the new system: 10 sessions, each lasting 12 minutes (about 2 weeks, Monday-Friday).
WHAT HAPPENS DURING TREATMENT?
The equipment includes:
Brain monitoring device: Safe infrared light sensors placed on the patient's head (like a cap) Computer software: Reads brain signals when the patient thinks about walking Foot device: Special pneumatic shoes that provide gentle pressure to the patient's feet Screen: Shows visual feedback during training.
What the patient will do:
Sit comfortably in a chair with special shoes on their feet, Complete the task: imagine walking or relax when instructed, What the patient will experience: They will see colors change on the screen and feel gentle pressure on their feet.
详细描述
INTERVENTION NIRS-BCI-Korvit System Components: NIRScout hardware-software complex (16 light sources, 8 detectors); Software for brain activity classification; Korvit pneumoorthesis for plantar support load reproduction; 22-inch monitor for task demonstration Training Procedure: Patient seated with lower limbs fixed in pneumatic orthoses; Task: kinesthetically imagine walking or relax; Feedback: visual (color change on screen) and tactile (support load through orthosis).
Training structure: 16 blocks alternating walking imagination and relaxation/ ASSESSMENT
Motor Function:
- Fugl-Meyer Scale for Lower Extremity (maximum 34 points, clinically significant improvement ≥6 points);
- 10-meter Walk Test (clinically significant improvement ≥0.16 m/s);
- Timed Up and Go Test (clinically significant improvement ≥3 seconds).
Cognitive Functions and Emotional State:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Primary or recurrent supratentorial ischemic stroke
- •Stroke onset 7 days to 24 months
- •Moderate to mild post-stroke lower limb motor impairments
- •Clinical stability
- •Voluntary participation and signing of informed consent
排除标准
- •Severe cognitive impairments preventing instruction compliance
- •Sensory or severe motor aphasia
- •Severe visual impairments
- •Lower limb contractures
- •Inability to maintain sitting position
研究组 & 干预措施
BCI
Stroke patients receiving NIRS-BCI-pneumoorthesis training in combination with standard therapy
干预措施: NIRS-BCI-pneumoorthesis (Device)
Control
Stroke patients receiving standard therapy
结局指标
主要结局
Walking speed change as assessed by the 10-Meter Walk Test
时间窗: From enrollment to the end of treatment at 2 weeks
Before and after treatment course
Lower extremity functional improvement as assessed by the Fugl-Meyer Assessment
时间窗: From enrollment to the end of treatment at 2 weeks
Before and after treatment course
次要结局
- Lower extremity functional improvement as assessed by the Timed Up and GO test(From enrollment to the end of treatment at 2 weeks)
- Cognitive function improvement as assessed by the Addenbrooke's cognitive examination - III("From enrollment to the end of treatment at 2 weeks)
研究者
Natalia Suponeva
Director of Institute
Research Center of Neurology, Russia