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

NCT05575674 | Completed FDA Device

• 1 other identifier: PRO-002
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

MyoPro

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Myoelectric Elbow-Wrist-Hand Orthosis DEVICE

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.

Also known as: MyoPro®

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult with upper limb impairment caused by brachial plexus injury, stroke, or spinal cord injury, or other neurological disease or injury who have been fitted with a myoelectric Elbow-Wrist-Hand orthosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myomo: lead
• Orthocare Innovations, LLC: collaborator
• Geauga Rehabilitation Engineering, Inc.: collaborator

Study Sites (3)

Myomo, Inc.

Boston, Massachusetts, 02114, United States

Location

Geauga Rehabilitation Engineering, Inc.

Chardon, Ohio, 44024, United States

Location

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sarah Chang

  Orthocare Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: October 5, 2022
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)