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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke, Brachial Plexus Injury, Spinal Cord Injuries, Neurological Disease

Intervention / Treatment
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* Device: Myoelectric Elbow-Wrist-Hand Orthosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Myoelectric Elbow-Wrist-Hand Orthosis|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.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MyoPro