[ARTICLE] Feasibility, Safety and Efficacy of a Virtual Reality Exergame System to Supplement Upper Extremity Rehabilitation Post-Stroke: A Pilot Randomized Clinical Trial and Proof of Principle – Full Text

Abstract

(1) Background: Increasing the amount of therapy time has been shown to improve motor function in stroke survivors. However, it is often not possible to increase the amount of therapy time provided in the current one-on-one therapy models. Rehabilitation-based virtual reality exergame systems, such as Jintronix, can be offered to stroke survivors as an adjunct to traditional therapy. The goal of this study was to examine the safety and feasibility of providing additional therapy using an exergame system and assess its preliminary clinical efficacy.
(2) Methods: Stroke survivors receiving outpatient rehabilitation services participated in this pilot randomized control trial in which the intervention group received 4 weeks of exergaming sessions in addition to traditional therapy sessions.
(3) Results: Nine subjects in the intervention and nine subjects in the control group completed the study. The intervention group had at least two extra sessions per week, with an average duration of 44 min per session and no serious adverse events (falls, dizziness, or pain). The efficacy measures showed statistically meaningful improvements in the activities of daily living measures (i.e., MAL-QOM (motor activity log-quality of movement) and both mobility and physical domains of the SIS (stroke impact scale) with mean difference of 1.0%, 5.5%, and 6.7% between the intervention and control group, respectively) at post-intervention.
(4) Conclusion: Using virtual reality exergaming technology as an adjunct to traditional therapy is feasible and safe in post-stroke rehabilitation and may be beneficial to upper extremity functional recovery.

1. Introduction

Hemiplegia, weakness of one side of the body, is a common consequence of stroke that can lead to significant functional impairments, including loss of arm function that occurs in up to 85% of stroke survivors [1]. The impact of arm-related limitations on activities of daily living, leisure activities, or work is significant as the arm plays a central role in a person’s life from the ability to perform basic activities of daily life to carrying out family and social roles. Guidelines indicate that rehabilitation can improve upper extremity (UE) motor control and functional status post-stroke [2]. Intense and repetitive training post-stroke is widely recognized as being essential to maximize recovery and promote plasticity in the central nervous system [2,3,4,5,6]. However, in reality, the feasibility of providing intensive rehabilitation may be limited in a rehabilitation setting by a lack of resources or motivation from the patient [7]. Furthermore, stroke survivors discharged from acute care receive physical and occupational therapy services primarily in rehabilitation centers, on an in- and out-patient basis or at home, but budgetary constraints and shortage of specialized health care professionals limit accessibility to much needed rehabilitation services.
New models of service delivery and maximizing the use of existing resources are therefore essential. With the emergence of interactive technologies or “gamified” products, innovative treatment strategies are being developed. Virtual reality (VR) and computer games are recent technologies that, as they become more accessible and affordable [8], are increasingly being used in rehabilitation to allow patients to engage in repetitive practice of specific tasks. The so-called exergames or exergaming reflect the idea of exercising through computer games. A number of published reviews and meta-analyses have examined the use of VR and video games for post-stroke rehabilitation, focusing on or including UE rehabilitation [3,4,6,8,9,10,11].
Saposnik and his colleagues [9] examined the effectiveness of rehabilitation using VR on UE motor function post-stroke in a meta-analysis study. In total, 11 of the 12 included studies (5 randomized controlled trials and 7 pre-post interventions) showed a benefit on the primary outcome, with the pooled randomized controlled trials showing a 4.9 higher chance of improvement in motor impairment when VR was used in comparison to control. Similarly, another meta-analysis study included a subgroup of studies related to UE function [6] and showed that VR had a significant effect on arm function (seven studies) and activities of daily living (ADL) (three studies) in comparison to control groups. The updated Cochrane Review of the meta-analysis concluded that virtual reality has a statistically significant effect on upper limb function (based on 12 studies) and ADL outcome (based on 8 studies) [12]. Another meta-analysis looked at the effect of virtual environments and commercial games on each category of the International Classification of Function, Disability, and Health (ICF), i.e., body function, activity, and participation, in post-stroke rehabilitation [11]. The authors reported that there was a significant effect of using virtual environments in improving all three ICF categories and that these outcome improvements by VR rehabilitation are moderately higher than conventional therapy [11]. However, there is still insufficient evidence regarding the best dose of therapy, timing, and types of programs. In addition, few studies report the users’ perception of these technologies, for both patients and therapists, although Lange and her colleagues [4] discussed the importance of activity enjoyment in their review. Celinder and Peoples [13] studied patients’ experiences through interviews and observation of patients using the Wii Sports for in-patient rehabilitation post-stroke. Most patients reported that the Wii provides them with variety, more stimulation, and more meaningful activities in their rehabilitation. Overall, studies agree that there is limited but promising findings that VR and video games, when combined with conventional rehabilitation, have a positive impact on recovery post-stroke. Furthermore, the literature in the field of technology adoption suggests that the user’s perception plays an important role in the actual use of the technology [14].
The Jintronix system (Jintronix Inc., www.jintronix.com), based on the Microsoft Kinect technology, is one such product that allows patients who have had a stroke to train UE movements independently using challenging and engaging programs tailored to their level of ability. This exergame system allows therapists to objectively track patients’ activities during their recovery process and to adjust, as required, the training program. Graded tasks that challenge and provide feedback to the patient can optimize motor learning [2,15]; this system has embedded this concept in their exergames. In addition, eventually, the tracking functionality that the exergame system offers could allow patients to train without direct therapist supervision, thereby offering interesting opportunities for increased dosage of in-clinic rehabilitation as well as for home-based tele-rehabilitation. In other words, following a stroke, people could participate in a more intensive rehabilitation training without increasing staffing. That being said, prior to using this exergame system in a clinical setting when used as an adjunct to conventional therapy, its feasibility, safety, and efficacy must be assessed.
The goals of this pilot study were to assess the feasibility and safety of the rehabilitation exergaming system and to provide preliminary evidence regarding its clinical efficacy for UE functional recovery post-stroke as a supplement to conventional rehabilitation services, as proposed by Saposnik and colleagues [9]. The results of this study will serve as a basis for a larger multicenter trial, in order to determine the effectiveness of exergame systems as a supplement to UE therapy post-stroke.[…]

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Figure 1. The Jintronix rehabilitation exergaming system.

 

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