Abstract
BackgroundConstraint-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.MethodsThis 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).DiscussionThis 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 registrationClinicaltrials.gov, NCT02631850.
Highlights
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
Clinical practice guidelines recommend outpatient rehabilitation for stroke survivors who remain disabled after discharge from inpatient rehabilitation [1]
Higher initial motor ability has been associated with 25% and 200% greater improvements in arm use (UAB Traditional CI therapy/ Ohio State University (OSU) Gaming CI therapy cohorts, respectively), and 25% lesser improvement on the Wolf Motor Function Test (WMFT) [63]
Summary
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. In an observational study of 312 rehabilitation sessions (83 occupational and physical therapists at 7 rehabilitation sites), Lang and colleagues [4] found that functional rehabilitation (i.e., movement that accomplishes a functional task, such as eating, as opposed to strength training or passive movement) was provided in only 51% of the sessions of upper extremity rehabilitation, with only 45 repetitions per session on average. This is concerning given that empirically-validated interventions incorporate higher doses of active motor practice [5,6,7]. Passive movement and non-goaldirected exercise are more frequently administered [4]
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