Trials / Completed
CompletedNCT05575674
Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes
Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes During Home Use
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- Myomo · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-10-05
- Primary completion
- 2023-04-11
- Completion
- 2023-04-11
- First posted
- 2022-10-12
- Last updated
- 2023-10-10
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05575674. Inclusion in this directory is not an endorsement.