Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial

BACKGROUND: There is compelling evidence of beneficial effects of non-immersive virtual reality (VR)-based intervention in the rehabilitation of patients with stroke, whereby patients experience both the real world and the virtual environment. However, to date, research on immersive VR-based rehabilitation is minimal. This study aims to design a randomized controlled trial to assess the effectiveness of immersive VR-based upper extremity rehabilitation in patients with subacute stroke and explore the underlying brain mechanisms of immersive VR-based rehabilitation. METHODS: Subjects (n = 60) with subacute stroke (defined as more than 1 week and less than 12 weeks after stroke onset) will be recruited to participate in a single-blinded, randomized controlled trial. Subjects will be randomized 1:1 to either (1) an experimental intervention group, or (2) a conventional group (control). Over a 3-week time period immediately following baseline assessments and randomization, subjects in the experimental group will receive both immersive VR and conventional rehabilitation, while those in the control group will receive conventional rehabilitation only. During the rehabilitation period and over the following 12 weeks, upper extremity function, cognitive function, mental status, and daily living activity performance will be evaluated in the form of questionnaires. To trace brain reorganization in which upper extremity functions previously performed by ischemic-related brain areas are assumed by other brain areas, subjects will have brain scans immediately following enrollment but before randomization, immediately following the conclusion of rehabilitation, and 12 weeks after rehabilitation has concluded. DISCUSSION: Effectiveness is assessed by evaluating motor improvement using the arm motor section of the Fugl-Meyer assessment. The study utilizes a cutting-edge brain neuroimaging approach to longitudinally trace the effectiveness of both VR-based and conventional training on stroke rehabilitation, which will hopefully describe the effects of the brain mechanisms of the intervention on recovery from stroke. Findings from the trial will greatly contribute to evidence on the use of immersive-VR-based training for stroke rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03086889. Registered on March 22, 2017.