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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05575674
Other study ID # PRO-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 5, 2022
Est. completion date April 11, 2023

Study information

Verified date October 2023
Source Myomo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date April 11, 2023
Est. primary completion date April 11, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Myomo, Inc. Boston Massachusetts
United States Geauga Rehabilitation Engineering, Inc. Chardon Ohio
United States Orthocare Innovations, LLC Edmonds Washington

Sponsors (3)

Lead Sponsor Collaborator
Myomo Geauga Rehabilitation Engineering, Inc., Orthocare Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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