Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment
研究概览
简要总结
In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb. The device is wearable and light-in-weight for unilateral application during walking. It is hypothesized that with the intervention of the ENMS-BSF the gait pattern of persons after stroke can be improved with long-term rehabilitative effects.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months after the onset of stroke
- •Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score >21).
- •Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance.
- •Fugl-Meyer Assessment (FMA), total score on the lower limb <20
- •Functional Ambulatory Category (FAC) ≥4
- •Berg Balance Scale (BBS) ≥40
排除标准
- •The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) >
- •Receiving other lower limb rehabilitative interventions at the same time
研究组 & 干预措施
ENMS-BSF assisted gait training
The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation.
干预措施: ENMS-BSF assisted gait training (Device)
Partial ENMS-BSF assisted gait training
The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation.
干预措施: ENMS-BSF assisted gait training (Device)
Sham ENMS-BSF assisted gait training
The participants will only wear the device without assistance during a 20-session gait rehabilitation.
干预措施: ENMS-BSF assisted gait training (Device)
结局指标
主要结局
Change in Fugl-Meyer Assessment
时间窗: before, one day after, and 3 months after the training
To evaluate the voluntary motor function of the lower limb after the interventions
次要结局
未报告次要终点
研究者
Xiaoling Hu
Assistant Profession
The Hong Kong Polytechnic University