Training the Arm and Hand After Stroke Using Auditory Rhythm Cues
Condition: Stroke; Hemiplegia
MeSH terms: Stroke; Hemiplegia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether or not having people with stroke practice
      performing tasks to auditory rhythm cues with their weaker arm and hand is any better at
      promoting improved motor control than practicing the tasks in a typical way without the
      rhythm cues
    

Detailed description: 
      Stroke is the leading cause of adult-onset disability in the United States, and 75% of those
      presenting with UE deficits continue to have decreased UE function, despite rehabilitation.
      Despite demonstrated efficacy that functional task practice promotes improved UE function
      post-stroke,4-6 most subjects continue to have substantial disability, reporting less paretic
      hand use than pre-stroke and having lower scores on motor tests. Auditory rhythm entrainment
      of functional task practice may enhance therapy efficacy by facilitating the adoption of more
      normal movement patterns. Thus, it is critical to public health that more effective
      approaches to facilitate UE motor recovery are developed. This study would further the
      mission of NCMRR to enhance independence of persons with disability and that of NICHD:
      "optimal well-being of all people through rehabilitation."

      The primary aim of this pilot study is to gather preliminary data on the impact of auditory
      rhythm entrainment of functional task practice (FTARC) on improvement in UE function compared
      to functional task practice alone (FTP) in subjects with moderate hemiparesis from chronic
      stroke. Our primary hypothesis is that after FTARC, subjects will demonstrate greater gains
      in UE function compared to persons in the FTP group. Secondary aims are to understand 1) the
      relative impact of FTARC on retention of motor skills 6 months after therapy and 2) to
      understand how changes in more underlying elemental components of UE movement, (kinetic
      parameters and multi-joint synergies) relate to this improvement in outcome. Our secondary
      hypotheses are that the subjects with FTARC will demonstrate movement composition that is
      closer to that of neurologically intact individuals and greater retention of functional gains
      compared to subjects with FTP.

      This study will use a prospective, parallel group design in which subjects, after baseline
      testing, will be adaptively randomized by UE motor severity into either the FTARC or the FTP
      groups. Therapy will be 4 hours of task practice per weekday for 2 weeks. Subjects will wear
      a mitt on their non-paretic hand for 90% of waking hours. Subjects will then complete
      post-intervention and 6-month follow up testing.
    

Intervention name(s): Constraint-Induced Movement Therapy + auditory rhythm cues; Constraint-Induced Movement Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention is functional task practice with the paretic arm and hand for 4 hours/day for 10 sessions over 2 weeks plus a home program for the intervening weekend. Participants in the experimental group will perform this practice to the beat of a metronome. All participants will also wear a mitt on the less affected hand for up to 90% of waking hours.; The intervention is functional task practice with the paretic arm and hand for 4 hours/day for 10 sessions over 2 weeks plus a home program for the intervening weekend. All participants will also wear a mitt on the less affected hand for up to 90% of waking hours.
Other intervention name(s): Functional task practice, Forced use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; hemiplegia; stroke; upper extremity; motor skills; therapy