Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes

Completed

• Conditions: Neurological Disease; Stroke; Brachial Plexus Injury; Spinal Cord Injuries

• Registration Number: NCT05575674
• Lead Sponsor: Myomo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-10-05
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder and Hand (DASH)	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.

Trial Locations

Locations (3)

Myomo, Inc.; 🇺🇸 Boston, Massachusetts, United States

Geauga Rehabilitation Engineering, Inc.; 🇺🇸 Chardon, Ohio, United States

Orthocare Innovations, LLC; 🇺🇸 Edmonds, Washington, United States