Evaluating the effect of immersive virtual reality technology on gait rehabilitation in stroke patients: a study protocol for a randomized controlled trial

Abstract

Background: The high incidence of cerebral apoplexy makes it one of the most important causes of adult disability. Gait disorder is one of the hallmark symptoms in the sequelae of cerebral apoplexy. The recovery of walking ability is critical for improving patients' quality of life. Innovative virtual reality technology has been widely used in post-stroke rehabilitation, whose effectiveness and safety have been widely verified. To date, however, there are few studies evaluating the effect of immersive virtual reality on stroke-related gait rehabilitation. This study outlines the application of immersive VR-assisted rehabilitation for gait rehabilitation of stroke patients for comparative evaluation with traditional rehabilitation.

Methods: The study describes a prospective, randomized controlled clinical trial. Thirty-six stroke patients will be screened and enrolled as subjects within 1 month of initial stroke and randomized into two groups. The VRT group (n = 18) will receive VR-assisted training (30 min) 5 days/week for 3 weeks. The non-VRT group (n = 18) will receive functional gait rehabilitation training (30 min) 5 days/week for 3 weeks. The primary outcomes and secondary outcomes will be conducted before intervention, 3 weeks after intervention, and 6 months after intervention. The primary outcomes will include time "up & go" test (TUGT). The secondary outcomes will include MMT muscle strength grading standard (MMT), Fugal-Meyer scale (FMA), motor function assessment scale (MAS), improved Barthel index scale (ADL), step with maximum knee angle, total support time, step frequency, step length, pace, and stride length.

Discussion: Virtual reality is an innovative technology with broad applications, current and prospective. Immersive VR-assisted rehabilitation in patients with vivid treatment scenarios in the form of virtual games will stimulate patients' interest through active participation. The feedback of VR games can also provide patients with performance awareness and effect feedback, which could be incentivizing. This study may reveal an improved method of stroke rehabilitation which can be helpful for clinical decision-making and future practice.

Trial registration: Chinese Clinical Trial Registry ChiCTR1900025375 . Registered on 25 August 2019.

Keywords: Gait rehabilitation; Immersive virtual reality; Randomized controlled trials; Stroke rehabilitation.

Fig. 1

Research flow chart of the experiment

Fig. 2

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure (numbers beside t represent weeks)

Fig. 3

Virtual reality (VR) system and virtual scene. a A participant wears a virtual reality system. b A participant is carrying out crossbar training

Fig. 4

Four virtual reality training scenes. a Nine-grid training: participants can score points by trampling on the blue grid, and the color change speed of the grid can be adjusted. b Single-plank bridge training: participants can score points when they walk to the end of a single-plank bridge; the plank spacing of the bridge is adjustable. c Climbing stairs training: participants can score points for successful mountaineering to voice prompts. d Crossbar training: participants can score points when they cross the bar; the height of the bar is adjustable