https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5465449/
Abstract
Background
Constraint-Induced
Movement therapy (CI therapy) is shown to reduce disability, increase
use of the more affected arm/hand, and promote brain plasticity for
individuals with upper extremity hemiparesis post-stroke. Randomized
controlled trials consistently demonstrate that CI therapy is superior
to other rehabilitation paradigms, yet it is available to only a small
minority of the estimated 1.2 million chronic stroke survivors with
upper extremity disability. The current study aims to establish the
comparative effectiveness of a novel, patient-centered approach to
rehabilitation utilizing newly developed, inexpensive, and commercially
available gaming technology to disseminate CI therapy to underserved
individuals. Video game delivery of CI therapy will be compared against
traditional clinic-based CI therapy and standard upper extremity
rehabilitation. Additionally, individual factors that differentially
influence response to one treatment versus another will be examined.
Methods
This
protocol outlines a multi-site, randomized controlled trial with
parallel group design. Two hundred twenty four adults with chronic
hemiparesis post-stroke will be recruited at four sites. Participants
are randomized to one of four study groups: (1) traditional clinic-based
CI therapy, (2) therapist-as-consultant video game CI therapy, (3)
therapist-as-consultant video game CI therapy with additional therapist
contact via telerehabilitation/video consultation, and (4) standard
upper extremity rehabilitation. After 6-month follow-up, individuals
assigned to the standard upper extremity rehabilitation condition
crossover to stand-alone video game CI therapy preceded by a therapist
consultation. All interventions are delivered over a period of three
weeks. Primary outcome measures include motor improvement as measured by
the Wolf Motor Function Test (WMFT), quality of arm use for daily
activities as measured by Motor Activity Log (MAL), and quality of life
as measured by the Quality of Life in Neurological Disorders (NeuroQOL).
Discussion
This
multi-site RCT is designed to determine comparative effectiveness of
in-home technology-based delivery of CI therapy versus standard upper
extremity rehabilitation and in-clinic CI therapy. The study design also
enables evaluation of the effect of therapist contact time on treatment
outcomes within a therapist-as-consultant model of gaming and
technology-based rehabilitation.
Trial registration
Clinicaltrials.gov, NCT02631850.
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