StrokePhase 1/2NCT01322997
Robotic Brace Incorporating Electromyography (EMG) for Moderate Affected Arm Impairment After Stroke
A Phase 1/2 study testing Myomo e100 Robot and repetitive task specific training, Repetitive task specific training (RTP) targeting the affected arm and Myomo e100 neurorobotic brace in people with Stroke, run by University of Cincinnati at 1 site in United States.
Trial summary
Stroke is the leading cause of disability in the United States. One of the reasons that it is so disabling is because of upper extremity hemiparesis (weakness in one arm), which is commonly seen after stroke. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Myomo e100 Robot and repetitive task specific training, Repetitive task specific training (RTP) targeting the affected arm and Myomo e100 neurorobotic brace
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2012
- Phase
- Phase 1/2
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper extremity Fugl Meyer score >10-< 25
- presence of volitionally activated EMG signal from the paretic biceps brachii of at least 5 ųV in amplitude
- stroke experienced > 1 month prior to study enrollment;
- a score > 24 on the Folstein Mini Mental Status Examination (MMSE)
- age > 35 < 85
- have experienced one stroke
- discharged from all forms of physical rehabilitation
- Myomo brace fits on affected arm properly and without discomfort (i.e., no red marks or discomfort observed in 10 minutes of use during fitting).
Who cannot join
- < 35 years old
- excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale
- excessive spasticity at the affected elbow, as defined as a score of > 4 on the Modified Ashworth Spasticity Scale
- currently participating in any experimental rehabilitation or drug studies
- apraxia (< 2.5 on the Alexander scale)
- severe sensory loss in affected hand (Nottingham sensory scale at least 75% of normal)
Show all 12Show fewer
- severe language deficits (score < 2 on NIH Stroke Scale question 9)
- Stroke that occurred in the brainstem
- A current medical history of uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
- History of neurological disorder other than stroke (other neurological disorders may affect the upper extremity motor performance of subjects.)
- Other significant pain or skin irritation in the upper extremity that would be exacerbated if by the use of the brace
- Substantial contracture of elbow, defined as > 20 degrees of elbow flexion, as measured at the baseline evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Univcersity of Cincinnati
Cincinnati, Ohio, 45267
Stephen Page, PhD, 513-558-2754, stephen.page@uc.edu
Stephen Page, PhD
About this study
Official title: Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke
Stroke is the leading cause of disability in the United States. One of the reasons that it is so disabling is because of upper extremity hemiparesis (weakness in one arm), which is commonly seen after stroke.
The objective of this research is to see if a robotic system worn on the weakened arm like a brace is more useful in improving the strength and coordination of the affected arm, and those of other stroke survivors, than therapy only. Muscle weakness and lack of coordination after a stroke have great effects on how severely disabled the arm is and on quality of life after a stroke.
In this study, patients may be administered a new robotic brace as part of treatment for their affected arms. If they use this brace, your electromyography (EMG) signals will be used to control the powered arm brace. EMG signals are the small electrical signals that result from the actions of the muscles. The system will "listen" to patients' muscles, using small sensors that sit on top of the skin. The device will give the arm a "power-assist" when patients bend or straighten their elbows. The investigators want to test how easy and effective this system is to use. The investigators hypothesize that people using the robot will be more successful in their rehabilitative efforts - and that their movement will improve more - than people receiving traditional therapy.
- Conditions
- Stroke
- Being tested
- Myomo e100 Robot and repetitive task specific training, Repetitive task specific training (RTP) targeting the affected arm, Myomo e100 neurorobotic brace
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myomo e100 Robot and repetitive task specific trainingDevice
Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. This therapy will include about 1/2 an hour of use of a robot that targets arm function and assists with the movement of the affected arm, and about 1/2 an hour of repetitive task specific training (TRP) using the affected arm.
Repetitive task specific training (RTP) targeting the affected armBehavioural
Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. This therapy will include consist of repetitive task specific training (RTP) using the affected arm, in which patients use the arm to relearn valued movements using their arms.
Myomo e100 neurorobotic braceDevice
Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. Subjects will use a robot that targets arm function and assists with the movement of the affected arm.
| Study group | Role | What they receive |
|---|---|---|
| Myomo + RTP | Experimental | This group will be administered a regimen comprised of repetitive task specific practice (RTP) in conjunction with use of the robotic brace described elsewhere in this record. Receives: Device: Myomo e100 Robot and repetitive task specific training |
| Myomo | Active comparator | Patients in this group will only be administered the robotic brace described elsewhere in this record. Receives: Device: Myomo e100 neurorobotic brace |
| RTP only | Active comparator | Patients in this group will be administered repetitive task specific practice (RTP), emphasizing use of their affected arms during performance of valued, functional tasks. Receives: Behavioral: Repetitive task specific training (RTP) targeting the affected arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to after intervention and 3 months after intervention in the amount of active movement at each joint of the affected arm. This will be measured using the upper extremity section of the Fugl-Meyer Assessment.
The primary outcome in this study is arm impairment. We will measure this using the Fugl-Meyer; a stroke-specific measure that determines how much active movement patients exhibit at each joint of the affected upper extremity.
Measured: Twice before intervention; once after intervention; 2 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
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.
- More trials run by University of CincinnatiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322997
- Sponsor's protocol ID
- 1R03HD062545-01
- Status last verified
- Mar 2011
- First submitted
- 16 Mar 2011
- Last updated
- 25 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke
- ClinicalTrials.gov ID
- NCT01322997
- Acronym / sponsor ID
- 1R03HD062545-01
- Conditions
- Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 25 Mar 2011 (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.
Stroke is the leading cause of disability in the United States. One of the reasons that it is so disabling is because of upper extremity hemiparesis (weakness in one arm), which is commonly seen after stroke.
The objective of this research is to see if a robotic system worn on the weakened arm like a brace is more useful in improving the strength and coordination of the affected arm, and those of other stroke survivors, than therapy only. Muscle weakness and lack of coordination after a stroke have great effects on how severely disabled the arm is and on quality of life after a stroke.
In this study, patients may be administered a new robotic brace as part of treatment for their affected arms. If they use this brace, your electromyography (EMG) signals will be used to control the powered arm brace. EMG signals are the small electrical signals that result from the actions of the muscles. The system will "listen" to patients' muscles, using small sensors that sit on top of the skin. The device will give the arm a "power-assist" when patients bend or straighten their elbows. The investigators want to test how easy and effective this system is to use. The investigators hypothesize that people using the robot will be more successful in their rehabilitative efforts - and that their movement will improve more - than people receiving traditional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myomo + RTP | Experimental | Device: Myomo e100 Robot and repetitive task specific trainingThis group will be administered a regimen comprised of repetitive task specific practice (RTP) in conjunction with use of the robotic brace described elsewhere in this record. |
| Myomo | Active comparator | Device: Myomo e100 neurorobotic bracePatients in this group will only be administered the robotic brace described elsewhere in this record. |
| RTP only | Active comparator | Behavioral: Repetitive task specific training (RTP) targeting the affected armPatients in this group will be administered repetitive task specific practice (RTP), emphasizing use of their affected arms during performance of valued, functional tasks. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Upper extremity Fugl Meyer score >10-< 25
- presence of volitionally activated EMG signal from the paretic biceps brachii of at least 5 ųV in amplitude
- stroke experienced > 1 month prior to study enrollment;
- a score > 24 on the Folstein Mini Mental Status Examination (MMSE)
- age > 35 < 85
Key exclusion criteria (12 listed)
- < 35 years old
- excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale
- excessive spasticity at the affected elbow, as defined as a score of > 4 on the Modified Ashworth Spasticity Scale
- currently participating in any experimental rehabilitation or drug studies
- apraxia (< 2.5 on the Alexander scale)
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 |
|---|---|---|
| Myomo e100 Robot and repetitive task specific trainingSubjects in this group will be administered about an hour/day of therapy targeting the affected arm. This therapy will include about 1/2 an hour of use of a robot that targets arm function and assists with the movement of the affected arm, and about 1/2 an hour of repetitive task specific training (TRP) using the affected arm. | Device | Myomo + RTP |
| Repetitive task specific training (RTP) targeting the affected armSubjects in this group will be administered about an hour/day of therapy targeting the affected arm. This therapy will include consist of repetitive task specific training (RTP) using the affected arm, in which patients use the arm to relearn valued movements using their arms. | Behavioural | RTP only |
| Myomo e100 neurorobotic braceSubjects in this group will be administered about an hour/day of therapy targeting the affected arm. Subjects will use a robot that targets arm function and assists with the movement of the affected arm. | Device | Myomo |
Primary outcome
Change from baseline to after intervention and 3 months after intervention in the amount of active movement at each joint of the affected arm. This will be measured using the upper extremity section of the Fugl-Meyer Assessment.
Time frame: Twice before intervention; once after intervention; 2 months after intervention.
The primary outcome in this study is arm impairment. We will measure this using the Fugl-Meyer; a stroke-specific measure that determines how much active movement patients exhibit at each joint of the affected upper extremity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
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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 Phase 1/2 study testing Myomo e100 Robot and repetitive task specific training, Repetitive task specific training (RTP) targeting the affected arm and Myomo e100 neurorobotic brace in people with Stroke, run by University of Cincinnati 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 12 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 25 Mar 2011. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stephen Page, PhD (513-558-2754, stephen.page@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to after intervention and 3 months after intervention in the amount of active movement at each joint of the affected arm. This will be measured using the upper extremity section of the Fugl-Meyer Assessment. (time frame: Twice before intervention; once after intervention; 2 months after intervention.). 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 25 Mar 2011.