Stroke Clinical Trial
Official title:
Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes During Home Use
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 |
Verified date | October 2023 |
Source | Myomo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Myomo | Geauga Rehabilitation Engineering, Inc., Orthocare Innovations, LLC |
United States,
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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