Feasibility Study on Portable Rehabilitation (PoRi) Device in Hand Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Feasibility assessed using the change in Modified Ashworth Scale (MAS) score
研究概览
简要总结
This study is a feasibility study of a new device that moves the hand of patients with spasticity to reduce hand muscle tone. The device's ability to improve spasticity before and after a 20-minute session with the device at Yale New Haven Hospital's outpatient clinic of Physical Medicine & Rehabilitation, or the Inpatient Rehabilitation Unit.
详细描述
Each patient will participate in a single 20 minute session, during which the device will extend and flex finger muscles. Each participant's duration will be approximately 1 hour during clinic, including time to address any further questions, to calibrate the device, and to measure the Modified Ashworth Score (MAS) before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Modified Ashworth Scale (MAS) score of at least 1
- •Participants with paralysis or motor function problems of the fingers of one or both hands.
排除标准
- •Minors (below age 18)
- •Vulnerable populations
- •Inability of fingers and wrist to stretch to neutral during passive range of motion
结局指标
主要结局
Feasibility assessed using the change in Modified Ashworth Scale (MAS) score
时间窗: immediately prior to intervention session and immediately following 20 minute intervention session
Muscle tone is rated on a 6-point scale (0, 1, 1+, 2, 3, 4) with higher scores indicating greater spasticity.
次要结局
- Device usability and accessibility survey(immediately following 20 minute intervention session)