Feasibility and safety of an immersive virtual reality-based vestibular rehabilitation programme in people with multiple sclerosis experiencing vestibular impairment: a protocol for a pilot randomised controlled trial

Cristina García-Muñoz, María Jesús Casuso-Holgado, Juan Carlos Hernández-Rodríguez, Elena Pinero-Pinto, Rocío Palomo-Carrión, María-Dolores Cortés-Vega, Cristina García-Muñoz, María Jesús Casuso-Holgado, Juan Carlos Hernández-Rodríguez, Elena Pinero-Pinto, Rocío Palomo-Carrión, María-Dolores Cortés-Vega

Abstract

Introduction: Vestibular system damage in patients with multiple sclerosis (MS) may have a central and/or peripheral origin. Subsequent vestibular impairments may contribute to dizziness, balance disorders and fatigue in this population. Vestibular rehabilitation targeting vestibular impairments may improve these symptoms. Furthermore, as a successful tool in neurological rehabilitation, immersive virtual reality (VRi) could also be implemented within a vestibular rehabilitation intervention.

Methods and analysis: This protocol describes a parallel-arm, pilot randomised controlled trial, with blinded assessments, in 30 patients with MS with vestibular impairment (Dizziness Handicap Inventory ≥16). The experimental group will receive a VRi vestibular rehabilitation intervention based on the conventional Cawthorne-Cooksey protocol; the control group will perform the conventional protocol. The duration of the intervention in both groups will be 7 weeks (20 sessions, 3 sessions/week). The primary outcomes are the feasibility and safety of the vestibular VRi intervention in patients with MS. Secondary outcome measures are dizziness symptoms, balance performance, fatigue and quality of life. Quantitative assessment will be carried out at baseline (T0), immediately after intervention (T1), and after a follow-up period of 3 and 6 months (T2 and T3). Additionally, in order to further examine the feasibility of the intervention, a qualitative assessment will be performed at T1.

Ethics and dissemination: The study was approved by the Andalusian Review Board and Ethics Committee, Virgen Macarena-Virgen del Rocio Hospitals (ID 2148-N-19, 25 March 2020). Informed consent will be collected from participants who wish to participate in the research. The results of this research will be disseminated by publication in peer-reviewed scientific journals.

Trial registration number: NCT04497025.

Keywords: adult neurology; multiple sclerosis; rehabilitation medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The Consolidated Standards of Reporting Trials flow diagram of the participants’ recruitment and progress through the phases of the trial.
Figure 2
Figure 2
Virtual environments of exergames from the VRi vestibular rehabilitation, Oculus Quest, Facebook. (1) Main room of First Steps; (2) Dance with Robot; (3) Shots in the Space; (4) Beat Sabre; (5) Tennis (Sports Scramble); (6) Baseball (Sports Scramble); (7) Bowling (Sports Scramble). VRi, immersive virtual reality.

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Source: PubMed

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