Effect on Upper Limb Training Using Rehabilitation Robot With Human-Computer Interaction Game Interface for Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment
研究概览
简要总结
A robot arm for upper limb rehabilitation is intended to achieve rehabilitation effects through the study of robot control theory and the integration of sensors such as sEMG. The goal is to reduce the workload of rehabilitation therapists.
详细描述
NTUH-ii is an upper limb rehabilitation robot. The aim of this robot is to reduce the workload of rehabilitation therapists and make the rehabilitation process more effective.
The robot can complete rehabilitation tasks, such as elbow flexion/extension, shoulder flexion/extension, and shoulder horizontal abduction/adduction, etc. By giving the desired trajectory, the robot can lead patients to do the tasks in passive mode or active mode.
However, curative rehabilitation should include the motion intention of patients. This study aimed to investigate the efficacy of rehabilitation effect by combining the sensors (such as sEMG, IMU) to obtain the motion intention of patients and give the assistive movement.
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
- None
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
- •First-time stroke, occurring between 2 weeks and 2 years after onset, resulting in unilateral hemiplegia.
- •Able to understand and follow simple instructions.
- •Able to maintain a sitting posture balance.
- •Rank on the Brunnstrom Scale is between two and five.
- •Both ischemic and hemorrhagic strokes are included.
排除标准
- •Not yet fully conscious.
- •Suffering from a psychiatric disorder or post-stroke psychiatric abnormalities.
- •Cognitive or behavioral impairments that affect the ability to comprehend or execute the experimental tasks.
- •Severe aphasia preventing compliance with researchers' instructions for this study.
- •Medical conditions in internal medicine that jeopardize patient safety, such as severe heart or lung diseases, or patients requiring bed rest.
- •Patients with a severe systemic illness requiring bed rest.
- •Patients with shoulder joint pathology unable to undergo exercise therapy.
- •Patients with severe osteoporosis who have concerns about fractures during physical activity.
- •Patients with arrhythmia and implanted cardiac pacemakers.
- •Severe uncontrolled seizures that cannot be improved with medication, physical therapy, botulinum toxin injections, or phenol block procedures.
结局指标
主要结局
Fugl-Meyer Assessment
时间窗: 1 month
Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.
次要结局
- sEMG analyzation(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
- Wolf Motor Function Test(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
- Motor evoked potential(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
- Fugl-Meyer Assessment(Before the task and right away the experiment, 3 months, 6 months post intervention.)
- Modified Ashworth Scale(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
- Stroke Impact Scale(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)