Vestibular rehabilitation through cave automatic virtual environment versus traditional physical therapy to improve balance in patients with multiple slcerosis: a multicenter randomized controlled trial

Abstract

Background: Patent ductus arteriosus (PDA) is the most common cardiac disease in preterm newborns. Cyclooxygenase inhibitors, mainly indomethacin and ibuprofen, have been largely used in the prevention of this pathology. However, this therapeuthic approach has lately been abandoned since more adverse effects are being reported. Besides that, since 2011, paracetamol is gaining more and more importance in the treatment ofBackground: Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system (CNS), it affects mainly women, ans usually occurs in young adults. Balance impairment is one of the initial and most common causes of severe disability in MS patients, it contributes significantly to reducing the patient morbility and risk of accidental falls, the patient independence and the ability to perform daily life activities. MS has no cure, treatments currently available aim to reduce relapses and delay progressive worsening of the disability. Therefore, management of MS patients is based on a multidisciplinary approach in wich traditional physical therapy is widely used and aims to enable patients to live better their disease. Recently vestibular rehabilitation (VR) based on cave automatic virtual environment (CAVE) has been introduced as a relevant novelty in the physical and psychological rehabilitation of neurological diseases, especially for gait and balance impairment. Objectives: This study aims to compare the efficacy of VR through CAVE with traditional physical therapy to improve balance in MS patients. In addition, efficacy on the risk of falls, gait, patient and caregiver quality of life (QoL), disability progression and cost-effectiveness will be analyzed. Design: We designed a multicenter randomized clinical tria, where we will select of a total of 206 individuals. The reference center for this trial will be the Hospital de Figueres, although collaboration and coordination will be required from both the Hospital Universitari de Girona Dr. Josep Trueta and the Hopital Germans Trias i Pujol to obtain the necessary sample. Methods: By randomization, we will allocate equally the participants in 2 groups, one group will recieve VR through CAVE and the other group will receive traditional physical therapy exercises. We will report any complications that may occur during of after the intervention. For the statistical analysis of balance improvement obtained with each therapy, Chi-square test will be used in case of parametric data, and Fisher exact test in case of non-parametric data. Participants: Men and women aged from 18 to 50 years old with a confirmed diagnosis of relapsing remitting MS (RRMS), balance impairment accofrding to the Berg Balance Scale (BBS) and Expanded Disability Status Scale (EDSS) score between 3 and 5