BMJ Open. 2021 Nov 22;11(11):e051478. doi: 10.1136/bmjopen-2021-051478.
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.
PMID:34810187 | DOI:10.1136/bmjopen-2021-051478
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