Stroke Clinical Trial
Official title:
Auditory Rhythm Cues + Task Practice: Effects on UE Motor Function Post-stroke
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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