Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Fugl-Meyer assessment scale
研究概览
简要总结
The investigators developed a real-time 2-axis mirror robot system as a simple add-on module for conventional mirror therapy using a closed feedback mechanism, which allows for real-time movement of the hemiplegic arm. The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training.
详细描述
The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training. These tasks included more complicated tasks so that the participants would be interested in the tasks without the robot system.
Before and after 10 sessions of the therapy, the investigators conduct functional evaluations: the Fugl-Meyer assessment scale of the upper extremity (FMA-UE), the modified Ashworth scale, the modified Barthel index of upper extremity (MBI-UE: personal hygiene, bathing, feeding, and dressing), and the Jebsen hand function test, hand power measurement, and hemispatial neglect test (line bisection test and Albert's test) with the same occupational therapist. The motor evoked potential was measured for the patients without the history of brain surgery or seizure.
The investigators selected a thumb finding test (TFT) among various tools for assessing proprioception, because TFT is widely used and reliable. The TFT can be assessed, after confirming normal proprioception in the unaffected arm, by the patient touching the nose with their eyes closed while the examiner lifts the affected arm to eye level. The patient is then asked to grasp the thumb of the affected hand with the unaffected hand, and this is repeated. The examiner then places a hand over the patient's eyes and raises the patient's affected hand to well above the patient's head. The patient is then asked to grasp the thumb as before.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Supratentorial stroke diagnosed between 4 months and 6 years ago
- •Upper-limb hemiplegia with Medical Research Council grade 2 or less.
排除标准
- •Severe spasticity with modified Ashworth scale of grade 3 or more;
- •Mini-mental state examination score less than 12
- •Global or sensory aphasia.
结局指标
主要结局
Fugl-Meyer assessment scale
时间窗: Change from baseline data at 2 weeks
次要结局
- Jebsen hand function test(Before treatment, after 2 weeks, after 2 months)
- Hemispatial neglect test(Before treatment, after 2 weeks, after 2 months)
- Fugl-Meyer assessment scale(after 2 months)
- Modified Barthel index(Before treatment, after 2 weeks, after 2 months)
- Functional brain MRI(Before treatment, after 2 weeks)
- Thumb finding test(Before treatment, after 2 weeks, after 2 months)
- Modified Ashworth scale(Before treatment, after 2 weeks, after 2 months)
- Hand power(lb) assessed by dynamometer(Before treatment, after 2 weeks, after 2 months)
研究者
Sun Gun Chung
Professor
Seoul National University Hospital