Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke (NCT01654315) | Clinical Trial Compass
CompletedNot Applicable
Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke
United States34 participantsStarted 2012-03
Plain-language summary
Of the 5.7 million stroke survivors in the United States, up to 80% exhibit significant weakness in one arm (called "hemiparesis"). This devastating impairment undermines performance of valued activities and quality of life. Although rehabilitation is commonly provided, conventional affected arm rehabilitative strategies have negative evidence, or no evidence, supporting their use. Thus, there remains a need for evidence-based rehabilitative strategies for arm hemiparesis.
Newer rehabilitative approaches emphasize repetitive, task-specific practice (RTP) incorporating the affected arm. However, many of these promising regimens require participation in intensive therapies, and most are only efficacious on the least impaired patients. Thus, there remains a need for an efficacious, practical RTP technique to address moderate affected arm hemiparesis.
To address the above shortfalls, one of the investigators team members piloted an innovative brace integrating electromyography (EMG) and robotics. In his case series, 8 stroke patients exhibiting moderate arm impairment successfully participated in RTP, with the brace (called the "Myomo") detecting and augmenting their movement attempts. Aided by the Myomo, participation in the RTP regimen reduced subjects' affected arm impairment and spasticity. The next logical step is to test Myomo + RTP efficacy using randomized controlled methods and an appropriate sample size.
Who can participate
Age range
35 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* upper extremity Fugl Meyer score \>10-\< 25 (i.e., subject must score between (and including) 10 and 25 on the UE FM at the baseline screening appointment only)
* 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).
* \< 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)
* severe language deficits (score \< 2 on NIH Stroke Scale question 9)
* Stroke that occurred in the brainstem (corticospinal tracts are the final pathway for the motor system, and are frequently damaged in brainstem strokes. These individuals are hypothesized to be less likely to benefit from the cortical plasticity seen with exercise therapy, and are therefore …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impairment in the Affected Upper Extremity as Measured by the Fugl Meyer Scale.
Timeframe: Administered twice before the intervention period. These two scores are averaged to provide a composite score that is compared to average score for each group that is collected 1 week after intervention