Exploratory Comparison of Movement Observation/Imagery-Timed Robot Activation and Repetitive Robot Activation on Training Effects and Neurophysiological Responses in Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Change in Event-Related Desynchronization (ERD) During Motor Tasks
研究概览
简要总结
This clinical trial compares two types of robotic hand rehabilitation-brain wave (EEG)-timed therapy versus simple repetitive therapy-to see which is more effective for recovering hand function in patients with chronic stroke. Participants will be randomly assigned to either group and will attend sessions using a wearable robotic hand device while wearing an EEG cap. In the EEG-timed group, the robot assists hand movements when participants successfully imagine moving and create specific brain signals, whereas in the repetitive group, the robot moves the hand automatically at set intervals. Both groups will receive a matched dose of robotic training to ensure a fair comparison of how the brain and hand function respond to the therapy.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with stroke.
- •Adults aged 19 to 85 years old at the time of screening.
排除标准
- •Patients with severe, uncontrolled medical conditions.
- •Patients with uncontrolled hypertension, diabetes mellitus, or renal disease.
- •Patients with severe cognitive impairment that prevents them from following instructions for motor tasks (Mini-Mental State Examination [MMSE] score of 15 or below).
- •Note: Patients with an MMSE score of 15 or below may still be included if the Principal Investigator (or a delegated physician) determines that they have the capacity to perform the tasks and provide informed consent.
研究组 & 干预措施
EEG-Timed Robot Therapy
干预措施: EEG-Timed Robot Operation (Device)
Repetitive Robot Therapy
干预措施: Repetitive Robotic System (Device)
结局指标
主要结局
Change in Event-Related Desynchronization (ERD) During Motor Tasks
时间窗: Baseline, Week 2, Week 4, and Week 6
Event-Related Desynchronization (ERD) is continuously measured using multi-channel EEG over the sensorimotor cortex while participants perform action observation and motor imagery (AO+MI) tasks. ERD represents the decrease in EEG power in specific frequency bands (e.g., mu or beta rhythms), which reflects the level of cortical activation. A greater magnitude of ERD indicates stronger and more active neurophysiological engagement of the motor cortex.
次要结局
- Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment (FMA-UE)(Baseline, Week 2, Week 4, and Week 6)
- Change in Upper Extremity Motor Performance Assessed by the Action Research Arm Test (ARAT)(Baseline, Week 2, Week 4, and Week 6)
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital