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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05575674
Enrollment
21
Registered
2022-10-12
Start date
2022-10-05
Completion date
2023-04-11
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

MyoPro

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.

Interventions

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.

Sponsors

Orthocare Innovations, LLC
CollaboratorINDUSTRY
Geauga Rehabilitation Engineering, Inc.
CollaboratorUNKNOWN
Myomo
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disabilities of the Arm, Shoulder and Hand (DASH)Pre-MyoProValidated 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026