Clinical trial NCT05575674: Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes
Official title: Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes During Home Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Brachial Plexus Injury
Spinal Cord Injuries
Neurological Disease
Keywords: MyoPro
Lead sponsor: Myomo
Sponsor class: INDUSTRY
Collaborators: name: Orthocare Innovations, LLC
name: Geauga Rehabilitation Engineering, Inc.
First posted: 2022-10-12
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Pre-MyoPro
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: At least six months Post-MyoPro
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Myomo, Inc.
state: Massachusetts
city: Chardon
country: United States
facility: Geauga Rehabilitation Engineering, Inc.
state: Ohio
city: Edmonds
country: United States
facility: Orthocare Innovations, LLC
state: Washington
Study officials:
affiliation: Orthocare Innovations, LLC
name: Sarah Chang
role: PRINCIPAL_INVESTIGATOR
References: