Experimental Evaluation of a Brain-Computer Interface Operated Hand Exoskeleton for Movement Restoration in Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- The hand functional recovery was measured using standard outcome measurement techniques such as grip strength(GS) using a dynamometer and action research arm test (ARAT) on the scale of 0 to 57. The performance of the brain activity was measured in terms of BCI classification accuracy and the event-related synchronization and de-synchronization in the brainwave.
研究概览
简要总结
The primary purpose of the study is to find out the impact of BCI operated hand exoskeleton based combined mental and physical practice on hemiplegic stroke patients for hand functional recovery. The study protocol involves the recruitment of hemiplegic stroke patients suffering from hand disability for at least 6 months and conducting a hand therapy for 12-16 sessions spanning over 3 months. The intervention was to trigger the hand-exoskeleton using the patient’s brain wave followed by an assist-as-needed physical practice using the hand-exoskeleton only. The hypothesis was that the proposed intervention would lead to the motor functional recovery of the disabled hand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 24.00 Year(s) 至 62.00 Year(s)（—）
- 性别
- All
入选标准
- •Stroke patients suffering from hand plegia.
- •Time since stroke greater than or equal to 6 months.
排除标准
- •1.Cognitively impaired.
- •2.Having a history of epilepsy.
- •3.Medically unstable.
- •High muscle spasticity in hand.
- •High tremor in hand.
结局指标
主要结局
The hand functional recovery was measured using standard outcome measurement techniques such as grip strength(GS) using a dynamometer and action research arm test (ARAT) on the scale of 0 to 57. The performance of the brain activity was measured in terms of BCI classification accuracy and the event-related synchronization and de-synchronization in the brainwave.
时间窗: The time points of outcome measurement were at every alternate session for GS and ARAT and for brain-activity it was at each session. It is to be noted that 2-3 sessions were done per week.
次要结局
- The secondary outcomes were the measurement of mood, fatigue and motivation of the participants on visual-analogue-scale (VAS) between 0 to 10.(Time points were after every session.)