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

NCT ID: NCT05575674

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-05

Study Completion Date

2023-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Brachial Plexus Injury Spinal Cord Injuries Neurological Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MyoPro®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Orthocare Innovations, LLC

INDUSTRY

Sponsor Role collaborator

Geauga Rehabilitation Engineering, Inc.

UNKNOWN

Sponsor Role collaborator

Myomo

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah Chang

Role: PRINCIPAL_INVESTIGATOR

Orthocare Innovations, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Myomo, Inc.

Boston, Massachusetts, United States

Site Status

Geauga Rehabilitation Engineering, Inc.

Chardon, Ohio, United States

Site Status

Orthocare Innovations, LLC

Edmonds, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

EMG-Based Hand-Wrist Control: Study B Mirrored
NCT04692571 COMPLETED EARLY_PHASE1