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N/A N=34 Randomized Triple-blind Treatment

Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke

Hemiparesis

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

OutcomeResultp-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.).
View full record on ClinicalTrials.gov →

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.

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