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

Qianqian Huang, Wei Wu, Xiaolong Chen, Bo Wu, Longqiang Wu, Xiaoli Huang, Songhe Jiang, Lejian Huang, Qianqian Huang, Wei Wu, Xiaolong Chen, Bo Wu, Longqiang Wu, Xiaoli Huang, Songhe Jiang, Lejian Huang

Abstract

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.

Keywords: Brain mechanism; Immersive virtual reality training; Magnetic resonance imaging; Randomized controlled trial; Stroke; Upper extremity.

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by the Second Hospital of Wenzhou Medical University Research Ethics Committee (reference number LCKY-2017-09). This trial is registered with ClinicalTrials.gov (NCT03086889). All participants must sign the written informed consent form. Participants are also given adequate time to decide if they wish to proceed with the trial or pursue other treatment options.

Consent for publication

The study findings will be published in open-access journals.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Chart of study flow. REDCap, Research electronic data capture; T1-MRI, high-resolution anatomical magnetic resonance imaging; RS-fMRI, resting-state functional magnetic resonance imaging; DTI, diffusion tensor imaging; VR, virtual reality
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments of the study. MRI (T1, RS-fMRI, DTI), magnetic resonance imaging (high-resolution anatomical, resting-state functional MRI, diffusion tensor imaging)
Fig. 3
Fig. 3
Virtual reality (VR) system and a virtual scenario. a A subject is wearing a VR system. b A subject is playing basketball
Fig. 4
Fig. 4
Six virtual reality (VR) programs. a Making scrambled eggs and frying dumplings in a virtual kitchen by controlling a hand and a pair of chopsticks, respectively. b Shooting ceramic plates and vases on a shelf by controlling a pistol in a virtual shooting gallery. c Playing a whack-a-mole game by controlling a wooden mallet hammer in a virtual playground. d Playing basketball in a virtual court, in which the ball is shot by a controller and the height and distance of the basket is varied over time. e Punching with dolls by controlling a big fist in a virtual boxing arena, in which the doll that is hit will retreat to its original position. f Popping balloons by controlling a sword in a virtual fencing hall

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