ParesisFAMENCT04266158
FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses
A study testing Myoelectric UE Device-UE Orthosis-No Device in people with Paresis and Stroke, run by Ohio State University at 1 site in United States.
Trial summary
The primary study objective is to compare post-stroke upper extremity (UE) movement while wearing a brace called the MyoPro 2 Motion G versus UE movement while wearing a resting splint and no device in stroke survivors with moderate UE dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Myoelectric UE Device-UE Orthosis-No Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 18 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Manual Muscle Test >1/5 in the paretic biceps, triceps, finger extensors and finger flexors;
- score > 10 < 30 on the Upper extremity Fugl Meyer AND active shoulder flexion of at least 30 degrees with device weight on affected arm;
- Ability to generate consistent, detectable EMG signal from the bicep/tricep upper arm and distal forearm flexor and extensor sensor sites with wrist in neutral, and fingers in neutral. At rest, achieve an EMG of 5 or below on myConfig (wrist and fingers in neutral and elbow extended); with gain at < 10 and boost <12, able to reach a threshold of 10 at both bicep and wrist flexors/extensors;
- a single stroke that is the cause of arm impairment, experienced >12 months ago; if there are additional asymptomatic lesions (as diagnosed by MRI), these subjects may also be included. Those with another symptomatic stroke in addition to the stroke causing arm impairment are excluded;
- score >70 on the Modified Mini Mental Status Examination;
- age >18< 85;
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- > 6 months since previous functional or therapeutic use of an upper extremity myoelectric orthosis;
- Height >5'0";
- Weight >110< 250 lbs.;
- Forearm circumference (at widest part) <13 in.;
- Bicep circumference >9 <15 in.;
- Upper arm length >5.5 in.;
- Wrist thickness (anterior- posterior) <1.75 in.;
- ability to stand with minimal assistance
Who cannot join
- > 5 on a 0-10 Numeric Pain Rating Scale for pain in the paretic hand, arm or shoulder;
- > 3 on the Modified Ashworth Spasticity Scale in the paretic elbow, >2 at wrist or fingers;
- < 2.5 on the Alexander Apraxia scale; '
- history of neurological disorder other than stroke;
- change in anti-spasticity medications in the last 6 months, and/or receipt of botulinum toxin in the paretic UE in the previous 4 months;
- elbow contracture greater than 10 degrees;
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- inability to passively extend fingers while wrist is in neutral;
- other conditions or physical/mental attributes that may undermine safety and/or full participation in the study;
- bilateral hemiparesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Assistance Provided by Myoelectric Elbow-wrist- Hand Orthosis
The primary study objective is to compare post-stroke upper extremity (UE) movement while wearing a brace called the MyoPro 2 Motion G versus UE movement while wearing a resting splint and no device in stroke survivors with moderate UE dysfunction. During the study, subjects will undergo general training in the operation of the EMG-controlled orthosis and the comparison orthosis, and then guided through a series of standard clinical outcome measures. These outcome measures will allow the researchers to directly compare the relative benefit of the MyoPro 2 Motion G with a resting hand splint and no device in reducing UE impairment and increasing UE dexterity and functional task performance.
- Being tested
- Myoelectric UE Device-UE Orthosis-No Device
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myoelectric UE Device-UE Orthosis-No DeviceDevice
all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects.
| Study group | Role | What they receive |
|---|---|---|
| MyoPro 2 Motion-G-orthosis-None | Active comparator | Following screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized. Receives: Device: Myoelectric UE Device-UE Orthosis-No Device |
| Comfy Splint | Active comparator | Following screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized. Receives: Device: Myoelectric UE Device-UE Orthosis-No Device |
| No Splint | Active comparator | Following screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized. Receives: Device: Myoelectric UE Device-UE Orthosis-No Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
0 - See Description
The PI is no longer at The Ohio State University and is not actively working at another institution for record transfer. We contacted remaining study team members and department chair to obtain updates for these records. We were told the PI was dismissed and there was alleged noncompliance and misconduct. The study team and department chair are unable to confirm if available documents for these records are accurate.
Measured: see description above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Oct 2017
- Primary completion18 Sep 2018
- Study completion18 Sep 2018
Why it stopped: Sponsor stoppage of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ParesisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, Northwestern University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266158
- Sponsor's protocol ID
- 2016H0339
- Acronym
- FAME
- Status last verified
- Mar 2022
- First submitted
- 10 Jan 2018
- Last updated
- 11 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assistance Provided by Myoelectric Elbow-wrist- Hand Orthosis
- ClinicalTrials.gov ID
- NCT04266158
- Acronym / sponsor ID
- FAME / 2016H0339
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stoppage of recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, Northwestern University
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Posted 11 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objective is to compare post-stroke upper extremity (UE) movement while wearing a brace called the MyoPro 2 Motion G versus UE movement while wearing a resting splint and no device in stroke survivors with moderate UE dysfunction. During the study, subjects will undergo general training in the operation of the EMG-controlled orthosis and the comparison orthosis, and then guided through a series of standard clinical outcome measures. These outcome measures will allow the researchers to directly compare the relative benefit of the MyoPro 2 Motion G with a resting hand splint and no device in reducing UE impairment and increasing UE dexterity and functional task performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MyoPro 2 Motion-G-orthosis-None | Active comparator | Device: Myoelectric UE Device-UE Orthosis-No DeviceFollowing screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized. |
| Comfy Splint | Active comparator | Device: Myoelectric UE Device-UE Orthosis-No DeviceFollowing screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized. |
| No Splint | Active comparator | Device: Myoelectric UE Device-UE Orthosis-No DeviceFollowing screening, all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, Comfy Splint orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. After these training sessions, all subjects complete a battery of three tests while wearing one of the two devices, or no device. The order in which the tests are administered is randomized. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Manual Muscle Test >1/5 in the paretic biceps, triceps, finger extensors and finger flexors;
- score > 10 < 30 on the Upper extremity Fugl Meyer AND active shoulder flexion of at least 30 degrees with device weight on affected arm;
- Ability to generate consistent, detectable EMG signal from the bicep/tricep upper arm and distal forearm flexor and extensor sensor sites with wrist in neutral, and fingers in neutral. At rest, achieve an EMG of 5 or below on myConfig (wrist and fingers in neutral and elbow extended); with gain at < 10 and boost <12, able to reach a threshold of 10 at both bicep and wrist flexors/extensors;
- a single stroke that is the cause of arm impairment, experienced >12 months ago; if there are additional asymptomatic lesions (as diagnosed by MRI), these subjects may also be included. Those with another symptomatic stroke in addition to the stroke causing arm impairment are excluded;
- score >70 on the Modified Mini Mental Status Examination;
Key exclusion criteria (9 listed)
- > 5 on a 0-10 Numeric Pain Rating Scale for pain in the paretic hand, arm or shoulder;
- > 3 on the Modified Ashworth Spasticity Scale in the paretic elbow, >2 at wrist or fingers;
- < 2.5 on the Alexander Apraxia scale; '
- history of neurological disorder other than stroke;
- change in anti-spasticity medications in the last 6 months, and/or receipt of botulinum toxin in the paretic UE in the previous 4 months;
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 UE Device-UE Orthosis-No Deviceall subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects. | Device | Comfy Splint, MyoPro 2 Motion-G-orthosis-None, No Splint |
Primary outcome
0 - See Description
Time frame: see description above
The PI is no longer at The Ohio State University and is not actively working at another institution for record transfer. We contacted remaining study team members and department chair to obtain updates for these records. We were told the PI was dismissed and there was alleged noncompliance and misconduct. The study team and department chair are unable to confirm if available documents for these records are accurate.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myoelectric UE Device-UE Orthosis-No Device in people with Paresis and Stroke, run by Ohio State University at 1 site 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 14 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
0 - See Description (time frame: see description above). 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 11 Apr 2022.