Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Lower Extremity
研究概览
简要总结
The investigators have developed a novel robot-guided stretching under intelligent control and combine it with active movement training, which helped increase joint ROM, reduce spasticity and joint stiffness, increase muscle force output, and improve locomotion. However, for stroke survivors with sensorimotor impairment, their peripheral muscle may not sufficiently be recruited. Functional electrical stimulation (FES), has been shown its advantage to activate the peripheral muscles for people with neurological conditions. The investigators thus make a hybrid robot-FES rehabilitation system, combining the advantage of robot and FES technologies for stroke motor recovery. The investigators further would like to translate the technologies from lab to home-based training. Thus, the investigators will conduct a randomized, controlled, primarily home-based clinical trial using an ankle robot alone or combined with functional electrical stimulation (FES) to treat sensorimotor and locomotion impairments post-stroke.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85;
- •Able to ambulate at least 10 meters without human assistance, with or without an assistive device
- •≥ 6 months post stroke;
- •having a caregiver to assist in training at home.
排除标准
- •having expressive and receptive aphasia;
- •an inability to follow multi-step commands;
- •enrolled in another lower limb rehabilitation program;
- •having severe pain in the paralyzed lower-limb;
- •>30º ankle plantar flexion contracture;
- •Having implanted electronic device such as a pacemaker, spinal cord, or deep brain stimulator because FES may potentially interfere with their functions.
结局指标
主要结局
Fugl-Meyer Lower Extremity
时间窗: 12 weeks
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
Dorsiflexion active range of motion
时间窗: 12 weeks
Joint ankle active range of motion measured by ankle robot.
6 minutes walking test
时间窗: 12 weeks
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
时间窗: 12 week
B-model ultrasound will be used to scan the muscle thickness, and the image will be further proceeded to measure the muscle thickness with unit in centimetres.
Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
时间窗: 12 week
B-model ultrasound will be used to assess the muscle thickness, muscle fiber pennation angle. Elasticity will be measured using ultrasound elastography.
次要结局
- Stroke Rehabilitation Assessment of Movement (STREAM)(12 weeks)
- Modified Ashworth Scale (MAS)(12 weeks)
- Timed up-to-go(12 weeks)
- Brief Balance Evaluation Systems Test(Brief-BESTest)(12 weeks)
- 10-meter walk test (10MWT)(12 weeks)
- Stiffness of medial gastrocnemius muscle and tibial anterior muscle.(12 weeks)
研究者
Li-Qun Zhang
Professor
University of Maryland, Baltimore