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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Spinal Cord Injuries; Brachial Plexus Injury; Neurological Disease
• Intervention / Treatment: Device: Myoelectric Elbow-Wrist-Hand Orthosis

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Myomo, Inc.
  • Ohio
    • Chardon, Ohio, United States, 44024
      • Geauga Rehabilitation Engineering, Inc.
  • Washington
    • Edmonds, Washington, United States, 98020
      • Orthocare Innovations, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult with upper limb impairment caused by brachial plexus injury, stroke, or spinal cord injury, or other neurological disease or injury who have been fitted with a myoelectric Elbow-Wrist-Hand orthosis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH)	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.	Pre-MyoPro
Disabilities of the Arm, Shoulder and Hand (DASH)	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.	At least six months Post-MyoPro

Collaborators and Investigators

• Sponsor: Myomo
• Collaborators: Orthocare Innovations, LLC; Geauga Rehabilitation Engineering, Inc.
• Investigators: Principal Investigator: Sarah Chang, Orthocare Innovations, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: MyoPro
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Nervous System Diseases; Spinal Cord Injuries
• Other Study ID Numbers: PRO-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No