StrokeNCT05575674
Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes
An observational study of Stroke and Brachial Plexus Injury, run by Myomo at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Brachial Plexus Injury, Spinal Cord Injuries
- What is being tested?
- Myoelectric Elbow-Wrist-Hand Orthosis
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Oct 2022to 11 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Myomo, Inc.
Boston, Massachusetts, 02114
Geauga Rehabilitation Engineering, Inc.
Chardon, Ohio, 44024
Orthocare Innovations, LLC
Edmonds, Washington, 98020
About this study
Official title: Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes During Home Use
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.
Read the 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.
- Being tested
- Myoelectric Elbow-Wrist-Hand Orthosis
- Keywords
- MyoPro
- Medical subject headings
- Stroke, Spinal Cord Injuries, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myoelectric Elbow-Wrist-Hand OrthosisDevice
Also called MyoPro®
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At least six months Post-MyoPro
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start5 Oct 2022
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myomo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orthocare Innovations, LLC, Geauga Rehabilitation Engineering, Inc.
- Responsible party
- Sponsor
- Investigators
- Sarah Chang, Principal investigator, Orthocare Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575674
- Sponsor's protocol ID
- PRO-002
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes During Home Use
- ClinicalTrials.gov ID
- NCT05575674
- Acronym / sponsor ID
- PRO-002
- Keywords
- MyoPro
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- MyomoIndustry (pharma, biotech, devices)
- Collaborators
- Orthocare Innovations, LLC, Geauga Rehabilitation Engineering, Inc.
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myoelectric Elbow-Wrist-Hand OrthosisAlso: MyoPro®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. | Device | – |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Pre-MyoPro
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.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: At least six months Post-MyoPro
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Chang principal investigator
Orthocare Innovations, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Brachial Plexus Injury, run by Myomo at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand (DASH) (time frame: Pre-MyoPro). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.