Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Investigate user experience by a self-composed questionnaire.
研究概览
简要总结
The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.
详细描述
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the usability of a new upper arm RAT device for upper arm rehabilitation in stroke patients is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow, which is combined with a stabilizing shoulder brace and a bionic glove.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Investigate user experience by a self-composed questionnaire.
时间窗: Up to 30 minutes at the last session
Investigate user experience by a self-composed questionnaire with theorems where upon users have to score. Possible scores range from 1 (totally disagree) to 4 (totally agree).
次要结局
- Measure the rate of perceived exertion by the Borg scale.(Up to 5 minutes at the last session)
- Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).(Up to 5 weeks (at week 1, week 2 and week 5))
研究者
Lieven De Maesschalck
Innovation Manager
Thomas More Kempen