Cerebrovascular AccidentsNCT02544672
Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis
A study testing Myoelectric Elbow-Wrist-Hand orthosis in people with Cerebrovascular Accidents, run by Myomo at 1 site in United States.
Trial summary
The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accidents
- What is being tested?
- Myoelectric Elbow-Wrist-Hand orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years.
- Upper limb impairment caused by any stroke (CVA)
- Minimum of trace MMT (1/5) in Biceps and/or Triceps
- Full Passive range of motion in elbow, forearm, wrist, and hand
- Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
- Score of at least 20 on the Mini Mental Status Examination.
- Ability to read and comprehend the English language.
- Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions.
Who cannot join
- Fixed upper limb contractures on affected side.
- Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
- Inability to follow three step directions.
- Severe shoulder subluxation, pain or shoulder dislocation.
- Passive shoulder range of motion less than 45 degrees in flexion and abduction.
- Pain or hypersensitivity in the arm(s)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
GRE Chardon
Chardon, Ohio, 44024
Jonathan Naft, CPO, LPO, 440-285-5785, jnaft@greop.com
About this study
The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).
Read the detailed description
The objective of this study is to evaluate the functional gains provided by a myoelectric Elbow-Wrist-Hand orthosis for CVA patients with hemiparesis. The subjects will be fit with the device, provided general training in the operation of the EMG-controlled technology, and then guided through a series of standard clinical outcome measures used routinely as part of stroke rehabilitation medicine. The outcome measures employed in this study include the Fugl-Meyer assessment, the Box and Blocks test, and a battery of common functional tasks and activities. These outcome measures will allow the researchers to approximate the changes in the subjects' ability to successfully perform functional tasks with and without the MyoPro device.
- Conditions
- Cerebrovascular Accidents
- Being tested
- Myoelectric Elbow-Wrist-Hand orthosis
- Medical subject headings
- Stroke
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.
| Study group | Role | What they receive |
|---|---|---|
| Myoelectric Elbow-Wrist-Hand Orthosis | Experimental | Not described Receives: Device: Myoelectric Elbow-Wrist-Hand orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Assessment of sensorimotor function for the upper extremities (arms)
http://www.rehabmeasures.org/lists/rehabmeasures/dispform.aspx?ID=908
Measured: 2 hours
Modified Ashworth Scale
Measurement of muscle spasticity due to nervous system injury or disease
http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902
Measured: 2 hours
Box and Blocks Test
An assessment of unilateral gross manual dexterity, measured by the number 1 inch cubes an individual can move over a barrier in a 60 second time period.
http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=917
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentsStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myomo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544672
- Sponsor's protocol ID
- 15-260
- Status last verified
- Sep 2015
- First submitted
- 1 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis
- ClinicalTrials.gov ID
- NCT02544672
- Acronym / sponsor ID
- 15-260
- Conditions
- Cerebrovascular Accidents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MyomoIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- 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 evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).
Detailed description
The objective of this study is to evaluate the functional gains provided by a myoelectric Elbow-Wrist-Hand orthosis for CVA patients with hemiparesis. The subjects will be fit with the device, provided general training in the operation of the EMG-controlled technology, and then guided through a series of standard clinical outcome measures used routinely as part of stroke rehabilitation medicine. The outcome measures employed in this study include the Fugl-Meyer assessment, the Box and Blocks test, and a battery of common functional tasks and activities. These outcome measures will allow the researchers to approximate the changes in the subjects' ability to successfully perform functional tasks with and without the MyoPro device.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myoelectric Elbow-Wrist-Hand Orthosis | Experimental | Device: Myoelectric Elbow-Wrist-Hand orthosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults over 18 years.
- Upper limb impairment caused by any stroke (CVA)
- Minimum of trace MMT (1/5) in Biceps and/or Triceps
- Full Passive range of motion in elbow, forearm, wrist, and hand
- Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
Key exclusion criteria (6 listed)
- Fixed upper limb contractures on affected side.
- Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
- Inability to follow three step directions.
- Severe shoulder subluxation, pain or shoulder dislocation.
- Passive shoulder range of motion less than 45 degrees in flexion and abduction.
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 | Myoelectric Elbow-Wrist-Hand Orthosis |
Primary outcome
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Time frame: 2 hours
Assessment of sensorimotor function for the upper extremities (arms) http://www.rehabmeasures.org/lists/rehabmeasures/dispform.aspx?ID=908
Modified Ashworth Scale
Time frame: 2 hours
Measurement of muscle spasticity due to nervous system injury or disease http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902
Box and Blocks Test
Time frame: 2 hours
An assessment of unilateral gross manual dexterity, measured by the number 1 inch cubes an individual can move over a barrier in a 60 second time period. http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=917
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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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.
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 Elbow-Wrist-Hand orthosis in people with Cerebrovascular Accidents, run by Myomo 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Sep 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Naft, CPO, LPO (440-285-5785, jnaft@greop.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Upper Extremity (FMA-UE) (time frame: 2 hours). The study lists 3 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 9 Sep 2015.