“FIND Technology”: investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial

In the US alone, one person per minute has a stroke, and although death rates have declined over the last decade, the burden of disease remains high [13]. Physical rehabilitation has the potential to positively impact functional outcomes and improve this burden; however, this requires a high dose of therapy. A significant factor limiting rehabilitation outcomes is low levels of patient activity [10]. Observational studies in different countries have found that patients after stroke in rehabilitation are surprisingly inactive for the vast majority of the waking day. For example, only 13 % of a stroke unit patient’s day is typically spent in activities related to functional outcome, such as active therapy or walking practice [2]. Many rehabilitation activities, aimed at stimulating neuroplasticity, are by their very nature repetitive and tend to be tedious [19]. One method by which engagement with rehabilitation programs and levels of activity could be improved involves the use of fun and engaging video games.

Commercial, off-the-shelf devices such as the Microsoft Xbox Kinect (Microsoft Corporation, Redmond, WA, USA) are relatively inexpensive and use motion capture and feedback technologies with potential for use in rehabilitation. Interactive video games increase adherence to and enjoyment of exercise in the general population [1] and have the potential to increase the dose of repetitive exercise completed by people with reduced mobility. Exercise-based video games could be used to increase exercise dose during therapy and to enable exercise outside of therapy hours. This is true both in inpatient and outpatient rehabilitation settings as well as at home after discharge from hospital.

In particular, the Kinect for Xbox 360, or simply Kinect, is a “controller-free gaming and entertainment experience” by Microsoft for the Xbox 360 video-game platform and is now also supported by PCs via Windows 8. It enables users to control and interact with the Xbox 360 without the need to touch a game controller, through a user interface using gestures and spoken commands. Kinect enables full-body depth-based three-dimensional motion-capture, facial recognition and voice recognition capabilities. This differentiates it from previous generations of interactive technologies that have been used in rehabilitation.

Despite the promise of such low-cost, consumer-based technologies, many, if not all, off-the-shelf video-game solutions are inappropriate for individuals with functional impairment [16]. There is an opportunity for purpose-built, clinically relevant video game-based rehabilitation to add significant value to current rehabilitation practice. Jintronix, a Montreal-based company, has recently launched a Kinect-based rehabilitation system, Jintronix Rehabilitation System (JRS), which provides an easy-to-use software solution (JRS WAVE) for patients to use. The software solution has been designed in collaboration with physical and occupational therapists and draws upon the motor relearning recommendations by Carr and Shepard [5]. As such, upper limb, sitting balance, standing balance and stepping rehabilitation tasks have been programmed in the JRS WAVE as fun and engaging video games that can be played at a number of different levels of complexity and speed. The system is also capable of automatically measuring changes in the range, speed and quality of motion to give patients instant feedback on their progress.

A second feature of the JRS WAVE is a cloud-based client management telehealth system for clinicians to recommend rehabilitation tasks and track and record performance of those tasks (JRS PORTAL). The PORTAL allows clinicians to provide patients regular updates and information on what has happened to them with daily, weekly or monthly progress reports on their rehabilitation, either face-to-face or remotely.

The proposed project will evaluate the feasibility, efficacy and safety of the JRS WAVE for use in an Australian stroke inpatient rehabilitation context. Elements of feasibility include recruitment into the trial, ongoing participation (adherence and dropout), perceived benefit, and enjoyment and ease of use of the games. Efficacy will be determined by measuring physical activity (using an accelerometer) and using upper-limb tasks as well as measuring changes in balance and mobility over time between the two groups. Adverse events will be monitored and changes in pain and fatigue with the interventions will be used to determine safety of the system. We will test the hypothesis that the intervention group will have increased levels of physical activity within rehabilitation and improved physical outcomes compared with the control group.

A single-blind randomized controlled trial will be conducted on two rehabilitation wards of a secondary referral hospital. Participants will be randomly assigned into the JRS WAVE intervention that will last for the duration of the stay on the ward, with a minimum dose of 8 days and maximum of 40 or usual care. All participants will provide written informed consent, and ethical clearance has been received.

Data Collection

Flow through the study is identified in Fig. 1.

The proposed project will discuss the feasibility and efficacy of the JRS WAVE. Uptake from screening to recruitment, adherence to the intervention and rates of dropout will be discussed. Feedback from clinicians in terms of system utility will be explored. Feedback from clients on the perceived benefits of this type of rehabilitation and enjoyment and ease of use of the games will also be discussed. Changes in pain and fatigue within each session and between the intervention and control groups will be analysed. Differences in activity levels during the two different interventions (JRS WAVE versus group exercise) will be investigated. Between-group differences for outcome measures of upper-limb function as well as balance and mobility will be investigated.

The primary outcome of efficacy consists of the differences in activity levels from using video technology in rehabilitation compared with usual rehabilitation. It will also provide data for new controller- and device-free motion capture software on measures of upper-limb function, balance and mobility. Much of the published research reviewing the effectiveness of interactive technology games with commercial devices has not used motion capture software in a controller-free situation. For example, the wii™ system for balance requires standing on a platform and the upper-limb tasks require the client to hold (or have strapped to their hand if they do not have grasp capacity) a device that the sensor recognises [6].

This software has been iteratively designed with feedback from the clinicians to form a system that meets the needs of stroke clients in the acute hospital setting as they begin their rehabilitation pathway. This system is vastly configurable, giving the clinicians the ability to tailor the program and modify it in an ongoing way to meet the needs of the clients. The different levels of disability of the clients enrolled will provide challenges when determining between-group differences.

Strengths of this study include that it collects feasibility data from both clients and clinicians. It is a well-powered study with an active control group to allow comparisons across a range of functional measures. Also, both groups are matched for time in rehabilitation (rather than the intervention as additional therapy) and this will allow direct comparison of the groups.

The novel nature of this bespoke software will provide valuable information to clinicians and researchers looking to improve engagement with rehabilitation, activity within rehabilitation and improved client outcomes in a cost-effective way.