N/A
N=34
Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke
Hemiparesis
Bottom Line
View on ClinicalTrials.gov: NCT01654315 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Impairment in the Affected Upper Extremity as Measured by the Fugl Meyer Scale. — 19.6; 18.0; 17.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Myomo Robotic Arm (Device); RTP Standard Therapy (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impairment in the Affected Upper Extremity as Measured by the Fugl Meyer Scale. |
19.6; 18.0; 17.6 | — |
| SECONDARY Arm Motor Ability Test (AMAT) |
29.21; 28.62; 25.33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- upper extremity Fugl Meyer score >10- 1 month prior to study enrollment
- a score > 24 on the Folstein Mini Mental Status Examination (MMSE)
- age > 35 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 ( 20 degrees of elbow flexion, as measured at the baseline evaluation. (The system cannot work in the presence of reduced range of motion due to contractures.).
Data sourced from ClinicalTrials.gov (NCT01654315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.