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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05575674
• Other study ID #: PRO-002
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Brachial Plexus Injury
• Nervous System Diseases
• Neurological Disease
• Spinal Cord Injuries
• Stroke
• Wounds and Injuries

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