Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke
Condition: Hemiparesis
MeSH terms: Paresis
Study type: Interventional

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.
    

Detailed description: 
      The primary objective of this small efficacy study is to collect randomized, controlled pilot
      data estimating clinical effectiveness of this combined, EMG/robotics approach in conjunction
      with RTP. A unique adjunct will be acquisition of biomechanical data as an outcome measure.
      Based on pilot data, the central hypothesis is that Myomo therapy with RTP will exhibit
      significant impairment reductions. We will test the central hypothesis and accomplish the
      objective by pursuing the following specific aims:

      Specific Aim 1: Compare efficacy of Myomo + RTP with RTP only and Myomo only on affected arm
      impairment. Thirty stroke patients exhibiting moderate affected arm deficits will be randomly
      assigned to receive: (a) Myomo combined with RTP (Myomo + RTP); (b) RTP only (RTP), which
      constitutes the most frequently used regimen in clinical environments;2,3 or (c) Myomo
      therapy only (Myomo). The current study design will determine the additive effect of Myomo
      training to RTP, while also discerning the relative efficacy of RTP only or Myomo use only.
      The intended duration of contact will be equivalent across groups.

      Affected arm impairment, the primary study outcome, will be measured by the upper extremity
      section of the Fugl-Meyer Impairment Scale (FM), the primary outcome measure. The FM will be
      administered by a blinded rater twice before intervention, immediately post-intervention
      (POST), and two months post-intervention (POST-2) with POST serving as the primary study
      endpoint. The primary study hypothesis is that subjects in the Myomo + RTP group will exhibit
      significantly larger FM score changes than Myomo or RTP subjects at POST. It is also
      hypothesized that these changes will be sustained at POST-2.

      Specific Aim 2: Determine the impact of Myomo + RTP on affected arm outcomes. The
      investigators will administer the Arm Motor Ability Test (AMAT), to all subjects before
      intervention, at POST, and at POST-2. When compared to their scores before intervention, it
      is hypothesized that Myomo + RTP subjects will exhibit significantly larger AMAT score
      changes,than subjects in the other groups at POST. These differences will be sustained at
      POST-2.
    

Intervention name(s): Myomo Robotic Arm; RTP Standard Therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Patients are administered rehabilitative therapy (repetitive task specific therapy,, also known as "RTP' in this study) using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period. These patients engage in RTP, which consists of a battery of activities that emphasize use of their affected arms repetitively, with the device providing assistance as needed with movement through the arm's range of motion.; Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period. In this condition, patients engage in activities that emphasize use of their affected arms repetitively, with the therapist providing assistance as needed with movement through the arm's range of motion. As patients progress, the amount of assistance provided by the therapist during the activities is reduced.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RTP Only Group; Myomo Only Group; Myomo + RTP Group