MyHand 2: An Active Hand Orthosis for Stroke Patients
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
- Device Usability and Utility Questionnaire Score
研究概览
简要总结
This study is designed to further develop and test the hardware and software components of the MyHand device based on user feedback and results from our pilot study. The goal is to refine the device so that is more effective and easier for stroke patients to use to increase their hand function.
详细描述
From previous experimentation with the MyHand device, the investigators have determined that the device can improve the grasping ability of stroke patients. The investigators now aim to make the controls more intuitive and accurate for the users, to enable subjects to grasp a wider array of objects, to make the donning and doffing of the device easier, and to continue to assess the MyHand as it helps subjects in functional tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adults over 18 years old
- •History of stroke(s) with most recent stroke at least six months ago
- •Upper extremity weakness with impaired ability to complete daily activities with affected hand
- •Full passive range of motion in all digits
- •Intact cognition to follow directions
- •Gross control of proximal upper extremity musculature
排除标准
- •Other neurological conditions besides stroke
- •Other orthopedic conditions to affected upper extremity
- •Significant spasticity in affected upper extremity that impairs device fit
研究组 & 干预措施
MyHand Treatment
Participants will use the MyHand device during repetitive grasp and release tasks.
干预措施: MyHand Device (Device)
结局指标
主要结局
Device Usability and Utility Questionnaire Score
时间窗: Up to 1 year at study completion
Subjects will provide feedback about their perceptions of the device's usability and utility for post-stroke upper extremity recovery. Four questions will be rated on a 5-point Likert scale (1) strongly agree to (5) strongly disagree. Five questions will be rated on a 5-point reverse Likert scale (1) strongly disagree to (5) strongly agree. The 9 question survey has a score range of 9-45 with higher scores indicating higher levels of device usability and utility.
次要结局
未报告次要终点
研究者
Joel Stein, MD
Professor and Chair of the Department of Rehabilitation and Regenerative Medicine
Columbia University