https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-017-0888-0
- Lynne V. GauthierEmail authorView ORCID ID profile,
- Chelsea Kane,
- Alexandra Borstad,
- Nancy Strahl,
- Gitendra Uswatte,
- Edward Taub,
- David Morris,
- Alli Hall,
- Melissa Arakelian and
- Victor Mark
BMC NeurologyBMC series – open, inclusive and trusted201717:109
DOI: 10.1186/s12883-017-0888-0
© The Author(s). 2017
Received: 22 November 2016
Accepted: 26 May 2017
Published: 8 June 2017
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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