Interactive Exoskeleton Robot for Walking - Knee Joint
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- 6-minute Walk Test
研究概览
简要总结
An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank and reduce the hyperextension in the knee joint. The robotic knee system is able to sense the gait pattern from the stroke patients and assist the walking and control the knee angle. The clinical trial will use repeated measurements to evaluate the effectiveness of the robotic knee system in gait rehabilitation post stroke.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrphagic stroke with drop foot problem.
- •Sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (Mini-Mental State Examination > 20)
- •Capable of standing and walking independently for an extended period of time. (Functional Ambulation Category > 3, Berg Balance Scale > 40)
排除标准
- •Any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy.
- •Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
- •Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the followup.
研究组 & 干预措施
Knee robot
This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton
干预措施: Knee robot (Device)
结局指标
主要结局
6-minute Walk Test
时间窗: 3-month followup
Walk as far a distance as possible over 6 minutes with their preferred speed; assistive devices can be used but kept consistent from test to test Individual should be able to ambulate without physical assistance.
Functional Ambulation Category
时间窗: 3-month followup
Patients can be rated on the following categories: 0: Patient cannot walk, or needs help from 2 or more persons 1. Patients needs firm continuous support from 1 person who helps carrying weight and with balance 2. Patient needs continuous or intermittent support of one person to help with balance and coordination. 3. Patient requires verbal supervision or stand-by help from one person without physical contact 4. Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces 5. Patient can walk independently anywhere
次要结局
- Kinematic and Kinetic Gait Motion Capture(3-month followup)
- Fugl-Meyer Assessment Lower Extremity(3-month followup)
- Timed 10-meter Walk Test(3-month followup)
- Modified Ashworth Scale(3-month followup)
- Berg Balance Scale(3-month followup)
研究者
Raymond KY Tong
Professor
Chinese University of Hong Kong