Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in the result of Box and blocks test
研究概览
简要总结
In the proposed study, the investigators assumed that high dose of repetitive motor task training using an exoskeleton robot-assisted system may provide benefits in motor shaping and greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of therapeutic activity with clinicians' guidance is often short of number in therapy sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the data they generate that are a new trend of rehabilitation strategy for providing remote home-programs support. The specific aim of this study is to to explore the feasibility of introducing the rental services of a Smart Home-based Exoskeleton Robot System through the IoT business model. And the second purpose is to investigate the effects of applying the exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic stroke patients.The expected outcomes of this research are to clarify the feasibility of using IoT business model for launching smart rehabilitation device rental service and the effects of application a high dosage of hand movement training as home program on motor and hand function for patients with chronic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •(1) chronic stroke patients with unilateral cerebral infarction or hemorrhage, (2) computed tomography scan that excluded pathologies other than unilateral cerebral hemisphere injury, (3) capacity to perform a pinch task with the thumb and index finger, (4) no major cognitive or perceptual deficit (i.e., visual, auditory, perceptual, praxis, and memory, as determined using Lowenstein occupational therapy cognitive assessment), (5) premorbid right-handedness and (6) first-ever stroke.
排除标准
- •not meeting inclusion criteria, and with Wernicke's aphasia or global aphasia leading to difficulty of following instruction.
结局指标
主要结局
Change in the result of Box and blocks test
时间窗: baseline, 4 weeks, 16 weeks and 20 weeks
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
次要结局
- Change in the result of Modified Ashworth scale (MAS)(baseline, 4 weeks,16 weeks and 20 weeks)
- Clinical global impression scale(post-intervention (week 4))
- Change in the result of Fugl-Meyer assessment for UE motor function(baseline, 4 weeks, 16 weeks and 20 weeks)
- Change in the result of Motor Activity Log(baseline, 4 weeks,16 weeks and 20 weeks)
- Change in the result of Semmes-Weinstein monofilament (SWM) test(baseline, 4 weeks,16 weeks and 20 weeks)