Effect of Task-oriented Training Assisted by Force Feedback Hand Rehabilitation Robot on Finger Function in Stroke Patients With Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Fugl-Meyer motor function assessment-upper limb finger motor part
研究概览
简要总结
Over eighty percent of stroke patients experience finger-grasping dysfunction problems, compromising independence in daily life activities and quality of life. In routine training, task-oriented training is usually used for functional training of the hand, which may improve the finger grasping performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, most of the hand rehabilitation robots commonly used in the clinic are based on passive training mode and lacks the sensory feedback function of fingers, which is not conducive to patients completing more accurate grasping movements. The force feedback hand rehabilitation robot can make up for the above defects, but its clinical efficacy in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the force feedback hand rehabilitation robot combined with task-oriented training for stroke patients with hemiplegia.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever stroke
- •Aged 20~80 years old
- •Post-stroke time≤6 months
- •Clinically diagnosed with a central paresis of the right arm/hand (Brunnstrom stage of the affected upper limb≥II, Brunnstrom stage of the affected hand II~V, Active flexion range of motion of the affected finger joint≥10°, MAS of affected upper limb and finger≤1+
- •Sitting balance≥Level 2
- •No serious depression and no visual impairment
- •Cognitive and speech abilities sufficient to understand instructions and to provide informed consent
排除标准
- •Severe additional neurological, orthopedic, or rheumatoid impairments before stroke which could interfere with task performance
- •Sensory disturbance of fingers
- •Severe joint pain caused by various reasons affects the functional activities of fingers
- •Complicated with serious heart, lung, liver, kidney or infection
- •Attending another study or therapy to improve arm-hand function
结局指标
主要结局
Fugl-Meyer motor function assessment-upper limb finger motor part
时间窗: Change from baseline Fugl-Meyer motor function assessment-upper limb finger motor part score at 4 weeks
Fugl-meyer motor function assessment-upper limb (FMA-UL) has been found a reliable and valid test for the assessment of arm hand function in stroke patients. The maximum score of on the FMA-UL is 66 points. This study used FMA-UL finger motor part , with a total score of 14 points.
次要结局
- Modified Ashworth scale (MAS)(Change from baseline Modified Ashworth scale outcome at 4 weeks)
- Range of motion (ROM)(Change from baseline range of motion outcome at 4 weeks)
- grip strength(Change from baseline grip strength at 4 weeks)
- Brunnstrom recovery stages of hand (BRS-H)(Change from baseline brunnstrom recovery stages of hand at 4 weeks)
- Barthel index (BI)(Change from baseline barthel index at 4 weeks)
研究者
Zhenlan li
department director
The First Hospital of Jilin University