Institutional Review Board of Chung Shan Medical University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- pedal force of affected leg
研究概览
简要总结
Background: Hemiplegia is one of the main reasons why stroke survivors lose their walking and balancing ability. Many studies point out that cycling is an effective means for lower limb rehabilitation. However, during training, the unaffected limb may compensate for the affected one resulting in suboptimal rehabilitation. To address this issue, the investigators developed the virtual reality-cycling training system (VRCTS) which can acquire force and speed signals in real-time through a cycling module. The system then analyzes the acquired data and uses a 3D VR rehabilitation program to help patients to train their affected side. The aim of the study was to develop the VRCTS, verify its function and test system function on both normal subjects and stroke patients.
Methods: In this system, the investigators designed a cycling device that is embedded with load cell and encoder sensors to detect cycling force and angle in real-time. A Cycling Graph User Interface Control and Data Recode System (Cycling CR System) was applied for signal analysis and feedback control. The investigators designed a 3D interactive VR rehabilitation program that can guide and train the users through visual feedback. Each user performed a pre-test to examine determine condition, left-right balance and other parameters, which allows the system to be customized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single stroke with unilateral hemiplegia (Brunnstrom stage III);
- •hypertonia in the affected leg, modified Ashworth scale (MAS) grade ≦ 2;
- •no significant perceptual, cognitive, or sensory deficits;
- •no history of osteoarthritis, severe cardiopulmonary disease, or vascular disease in lower limbs
- •lack of a fixed contracture in the affected lower limb
排除标准
- 未提供
结局指标
主要结局
pedal force of affected leg
时间窗: up to 24 weeks
次要结局
- asymmetrical ratio index(up to 24 weeks)
研究者
Chun-Yu Yeh
pofessor
Chung Shan Medical University
