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.
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).
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.
Clinical practice guidelines recommend outpatient rehabilitation for stroke survivors who remain disabled after discharge from inpatient rehabilitation . Although these guidelines recommend that the majority of stroke survivors receive at least some outpatient rehabilitation , many cannot access long-term care . Among those individuals who do undergo outpatient rehabilitation, the standard of care for upper extremity rehabilitation is suboptimal.
In an observational study of 312 rehabilitation sessions (83 occupational and physical therapists at 7 rehabilitation sites), Lang and colleagues  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]. Additionally, functional upper extremity movements are most likely to generalize to everyday tasks , an aspect of recovery that is critically important to patients and their families [9, 10, 11]. Yet, passive movement and non-goal-directed exercise are more frequently administered .
There appear to be at least two critical elements required for successful upper extremity motor rehabilitation: 1) motor practice that is sufficiently intense and 2) techniques to carryover motor improvements to functional activities. Carry-over techniques to increase a person’s use of the more affected upper extremity for daily activities are extremely important for rehabilitation and appear necessary for structural brain change [12, 13, 14, 15]. When rehabilitation incorporates these techniques, there is substantially improved improvement in self-perceived quality of arm use for daily activities [12, 16]. Carry-over techniques enable the patient to overcome the conditioned suppression of movement (learned nonuse) characteristic of chronic hemiparesis . Techniques include structured self-monitoring, a treatment contract, daily home practice of specific functional motor skills, and guided problem-solving to overcome perceived barriers to using the extremity .
Constraint-Induced Movement therapy (CI therapy) has strong empirical backing [5, 19] and combines high-repetition functional practice of the more affected arm with behavioral techniques to enhance carry-over [13, 18]. CI therapy produces consistently superior motor performance and retention of gains versus standard upper extremity rehabilitation [20, 21], particularly when it includes the critically important carry-over (transfer package) techniques . When compared to other equally intensive interventions (i.e., equal hours of training on functional tasks), CI therapy with carry-over (transfer package) techniques has also shown enhanced carry-over of clinical gains to daily activities [12, 13, 22, 23, 24] that are retained for at least 2 years [19, 25, 26, 27, 28].
Despite its inclusion in best practice recommendations [29, 30], CI therapy is available to only a very small minority of those who could benefit from it in the US. CI therapy is not typically covered by insurance and the 30+ hours of assessment and physical training cost upwards of $6000. Access barriers for the patient include limited transportation and insurance coverage, whereas therapists may have difficulty accommodating the CI therapy schedule [31, 32]. Access barriers aside, CI therapy has also been plagued by a variety of misconceptions regarding use of restraint and the transfer package. Most iterations of CI therapy employ use of a restraint mitt to promote use of the affected arm, which is viewed by many patients and clinicians as excessively prohibitive . Yet, literature demonstrates that restraint is not specifically required to achieve positive outcomes [33, 34]. Moreover, the transfer package, a component found to be critical [13, 14], is omitted from the majority of research studies on CI therapy .
To address transportation barriers, a telerehabilitation model of CI therapy delivery (AutoCITE) has been tested. AutoCITE is a large specialized motor apparatus (not commercially available, cost not established) that was installed in patients’ homes to enable therapeutic manipulation of actual objects with continuous video monitoring via Internet. This telerehabilitation approach demonstrated efficacy approximately equivalent to that of in-clinic CI therapy [36, 37, 38], thus establishing the feasibility of utilizing technology to deliver CI therapy remotely. However, this system involved specialized equipment at a high cost and did not become available outside a research setting.
To more fully address the barriers to accessing CI therapy and to counter the misconceptions surrounding CI therapy, a patient-centered treatment approach was developed that incorporated the high-repetition practice and carry-over strategies from CI therapy, while reforming non-patient-centric elements of the protocol that lack strong empirical support (i.e., the restraint). To deliver engaging high-repetition practice, a Kinect-based video game was created that can accommodate a wide range of motor disability, can be customized to each user, and automatically progresses in difficulty as the individual’s performance improves (termed “shaping” in the CI therapy literature). A player’s body movements drive game play (there is no external controller), which makes the game easy to use for those who may be unfamiliar with technology. To date, such high-repetition practice through motor gaming  has shown initial promise compared to traditional clinic-based approaches . To promote increased use of the weaker arm, a smart watch biofeedback application is utilized in lieu of the restraint mitt. This application counts movements made with the weaker arm and provides alerts when a period of inactivity is detected. Previous approaches for providing CI therapy in the home and reducing the amount of therapist effort have been carried out [36, 37, 38, 41]. These approaches automated the delivery of training and permitted remote supervision of the training via an Internet-based audio-visual link, but did not embed the training within the context of a video game, rely on manipulation of virtual objects, or incorporate a patient-centric substitute for the mitt.
Initial evidence from a pilot trial of this system (Borstad A, Crawfis R, Phillips K, Pax Lowes L, Worthen-Chaudhari L, Maung D, et al.: In-home delivery of constraint induced movement therapy via virtual reality gaming is safe and feasible: a pilot study, submitted) suggests that improvements in motor speed, as measured by Wolf Motor Function Test (WMFT) performance time , an outcome of prime importance to stroke survivors, are approximately equivalent to those reported in the traditional CI therapy literature [5, 13, 19, 25]. Qualitative data reveal that the technology is accepted irrespective of age, technological expertise, ethnicity, or cultural background. Thus, this technology has the potential to address the main barriers to adoption of CI therapy, while reducing the cost of care. A randomized clinical trial is now required to provide Level 1 evidence of the comparative effectiveness of this novel model of CI therapy delivery. Data from this trial will enable individuals with motor disability to evaluate whether a home-based video game therapy has the potential to help them meet their rehabilitation goals compared to in-clinic CI therapy and traditional approaches. By combining novel gaming elements with the transfer package from CI therapy, this trial will also address a major limitation of rehabilitation gaming interventions that have been tried to date: extremely limited emphasis on carry-over of training to daily activities.
The primary objective of this trial is to compare the effectiveness of two video game-based models of CI therapy versus traditional clinic-based CI therapy versus standard upper extremity rehabilitation for improving upper extremity motor function. One video gaming group will match the number of total hours spent on the CI therapy transfer package, but will involve fewer days of therapist-client interaction (4 versus 10); the other will match the number of interactions with a therapist to that of clinic-based CI therapy using video consultation between in-person sessions and, as such, will involve more therapist contact hours spent focusing on the transfer package. The secondary objective of this project is to promote personalized medicine by examining individual factors that may differentially influence response to one treatment versus another.
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