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NCT01654315 · ClinicalTrials.gov registry record · NA
Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT01654315: Completed NA study, sponsored by Ohio State University.
NCT01654315 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01654315, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study 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.
Primary Outcome
The upper extremity section of the Fugl-Meyer Scale (FM) will assess whether changes occur in paretic upper extremity motor impairment. The FM has been used extensively in stroke recovery studies, and is highly recommended for "use in clinical trials designed to evaluate changes in motor impairment following stroke." The items on the measure require the subject to perform various movements with the affected upper extremity, and each item is scored from 0 (cannot perform) to 2 (performs normally)
Interventions
- DEVICE Myomo Robotic Arm
- BEHAVIORAL RTP Standard Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-06 |
| Phase | NA |
What the finished NCT01654315 record still lists
NCT01654315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Myomo Robotic Arm is the first listed.
NCT01654315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01654315 about?
NCT01654315 is a clinical study titled "Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke". 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 reh...
What is the current status of trial NCT01654315?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2012-03. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01654315?
The interventions under investigation include: Myomo Robotic Arm (DEVICE), RTP Standard Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01654315?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01654315's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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