Retrospective Study on Myoelectric Elbo… | Clinical Trial

Key information

Conditions

Stroke Brachial Plexus Injury Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurological Disease Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Myomo, Inc., Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myoelectric Elbow-Wrist-Hand Orthosis

Device

An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.

Other names: MyoPro®

Primary outcomes

Disabilities of the Arm, Shoulder and Hand (DASH)

Time frame: Pre-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.
Disabilities of the Arm, Shoulder and Hand (DASH)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Myomo

Industry

Collaborators

Geauga Rehabilitation Engineering, Inc.
Orthocare Innovations, LLC

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Oct 12, 2022
Registry last updated: Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed