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临床试验/NCT05575674
NCT05575674已完成不适用

Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes During Home Use

Myomo3 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Myomo
入组人数
21
试验地点
3
主要终点
Disabilities of the Arm, Shoulder and Hand (DASH)

研究概览

简要总结

The objective of this study is to retrospectively evaluate the outcomes and clinical benefits provided by this brace to adult patients with upper limb impairment or paralysis due to brachial plexus, stroke (CVA), spinal cord injury, or other neurological disease or injury.

详细描述

The objective of this study is to retrospectively evaluate the outcomes and clinical benefits provided by this brace to adult patients with upper limb impairment or paralysis due to brachial plexus, stroke (CVA), spinal cord injury, or other neurological disease or injury.

The primary result in this study is a comparison of the Disabilities of the Arm, Shoulder and Hand questionnaire results that were completed before and at least six months after receiving the MyoPro. A retrospective record review will be done to collect data regarding MyoPro user outcomes for individuals that received a MyoPro starting January 2021 and after. Additional data types such as demographics and clinical outcomes will be gathered. Participants may complete at least one follow-up session to record responses to additional inquiries from the research team.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults, 65 years and older at the time of MyoPro delivery
  • Completed the DASH questionnaire at evaluation before receiving the MyoPro
  • Completed the DASH questionnaire at least six months after receiving the MyoPro
  • Has intact cognition
  • Able to clearly and verbally communicate in the English language

排除标准

  • Life-changing event(s) or change(s) in medical status that affected ability to use the MyoPro
  • Did not complete the DASH after receiving the MyoPro
  • Other conditions (e.g., cognitive issues) or circumstances that would preclude safe and/or effective participation

结局指标

主要结局

Disabilities of the Arm, Shoulder and Hand (DASH)

时间窗: At least six months Post-MyoPro

Validated outcome measure that asks an individual to self-report about the ability to perform certain upper limb activities. Questions are responded on a 5-point Likert scale.

次要结局

未报告次要终点

研究者

发起方
Myomo
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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