NCT03696927已完成不适用
Active Powered Prosthesis (APEX) for Spinal Cord Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- User Ability to Operate the APEX Device
研究概览
简要总结
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. The objective of this study is to perform focus groups with users and clinicians to evaluate a proof of concept active powered assistance device.
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
- •Spinal cord injury at levels C3 to C5, and AIS A, B, or C
- •Greater than 3-months post injury or surgery to the spinal column, arms, or shoulder
- •Ability to provide informed consent
- •Age 18 or over
- •Selected for participation based on investigator discretion
排除标准
- •Unable to follow instructions
- •Exhibit significant behavioral problems or impaired cognitive ability
- •Inability to provide consent
- •Non-English speaker
结局指标
主要结局
User Ability to Operate the APEX Device
时间窗: Two hours of in-clinic prototype evaluation
Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).
次要结局
未报告次要终点
研究者
研究点 (2)
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