Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
研究概览
简要总结
This study aims to design and verify a multi-mode smart assistive device system for Stroke Rehabilitation by using EEG, fMRI, IMU and questioners
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the first time hemiparetic stroke;
- •diagnosis confirmed by a physician on the basis of the findings of neurological examinations and brain imaging (magnetic resonance imaging or computed tomography scan);
- •aged between 20 and 85 years;
- •Brunnstrom's stage II to V over the proximal and distal part of the upper extremity on the affected side;
- •no cognitive dysfunction, measured by the Mini-Mental State Exam (≧24; suggested by 36 with respect to age and educational level)
- •willing/able to participate and having signed an informed consent form.
排除标准
- •unstable vital sign
- •irreversible contracture over any of the joints of the affected upper extremity
- •history of surgery, fracture, arthritis, pain, or any other complications that might influence the recovery of upper extremity function like aphasia, apraxia and neglect;
- •having spasticity, as measured using the Modified Ashworth scale (score > 2);
- •poststroke seizure;
- •heart attack within 3 months poststroke; cortical lesions in any of the five core motor areas of interest, including the bilateral M1, the bilateral PM, and the SMA.
研究组 & 干预措施
VR rehabilitation
Virtual Reality based rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).
干预措施: VR rehabilitation for motor function (Other)
control- conventional rehabilitation
conventional rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).
干预措施: VR rehabilitation for motor function (Other)
结局指标
主要结局
Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
时间窗: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
次要结局
- change in upper extremity performance evaluation test for the elderly (TEMPA)(pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ))
- change in Brunnstrom stage(pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ))
- change in Wolf motor function(pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ))
研究者
Chun-Chuan Chen
Associate professor
National Central University, Taiwan