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

Sponsor

Myomo (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05575674

Collaborator

Orthocare Innovations, LLC (Industry), Geauga Rehabilitation Engineering, Inc. (Other)

Enrollment

Locations

Anticipated Duration (Months)

16.7

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Brachial Plexus Injury Spinal Cord Injuries Neurological Disease	Device: Myoelectric Elbow-Wrist-Hand Orthosis

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 5, 2022

Anticipated Primary Completion Date :

Oct 4, 2023

Anticipated Study Completion Date :

Oct 4, 2023

Outcome Measures

Primary Outcome Measures

Disabilities of the Arm, Shoulder and Hand (DASH) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Myomo, Inc.	Boston	Massachusetts	United States	02114
2	Geauga Rehabilitation Engineering, Inc.	Chardon	Ohio	United States	44024
3	Orthocare Innovations, LLC	Edmonds	Washington	United States	98020

Sponsors and Collaborators

Myomo
Orthocare Innovations, LLC
Geauga Rehabilitation Engineering, Inc.

Investigators

Principal Investigator: Sarah Chang, Orthocare Innovations, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Myomo

ClinicalTrials.gov Identifier:

NCT05575674

Other Study ID Numbers:

PRO-002

First Posted:

Oct 12, 2022

Last Update Posted:

Oct 27, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Myomo

MyoPro

Additional relevant MeSH terms:

Spinal Cord Injuries

Nervous System Diseases

Wounds and Injuries

Study Results

No Results Posted as of Oct 27, 2022