MyHand-SCI: a Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- System Usability Scale
研究概览
简要总结
The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury.
详细描述
The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury. This is a non-randomized exploratory study to determine feasibility of device use, provide user feedback on device features and function to allow further refinement of the device, and assess the utility and responsiveness of several clinical outcome measures.
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
- 是
入选标准
- •Individuals with C6-C7 spinal cord injury, at least 6-months post-injury with impaired upper limb function
- •Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function
- •Able to provide informed consent
排除标准
- •Fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device
- •Severe spasticity (modified Ashworth >2) at elbow, wrist, or fingers
- •Any open wounds or unusual skin fragility
- •Persistent severe pain in their upper limb
结局指标
主要结局
System Usability Scale
时间窗: Up to 2 years at study completion
The System Usability Scale (SUS) is a reliable tool for measuring the usability of products, including medical devices. It consists of a 10 item questionnaire with five response options (Strongly agree to Strongly disagree).
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