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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 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 34 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01654315
The ClinicalTrials.gov registry entry for NCT01654315 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Myomo Robotic Arm is the first listed.
NCT01654315 reports 0 study locations.
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.
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