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      A Pilot Study to Explore Patient Satisfaction With a Virtual Rehabilitation Program in Multiple Sclerosis: The RehabVR Study Protocol

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          Abstract

          Background: Virtual reality (VR) has emerged as a promising treatment approach in rehabilitation for patients with multiple sclerosis (MS) due to its potential to increase patient motivation and rehabilitation adherence. One of the key features for rehabilitation adherence is patient satisfaction with the VR rehabilitation (VRR) program, and information on user satisfaction and not only effectiveness is required to systematically include VRR in routine clinical practice. Given that information on patient satisfaction with VRR is scarce, the primary objective of this study is to assess long-term patient satisfaction with a novel VRR program. This program has been specifically designed for MS patients by a multidisciplinary team of specialists, based on an effective conventional rehabilitation (CR) program. Secondarily, discomfort with VRR will be evaluated, and therapy adherence and changes in a variety of domains typically affected by MS will be compared between patients receiving VRR and patients receiving CR.

          Methods: In this prospective single-center 6-months follow-up study, 32 and 16 MS patients will receive VRR or CR, respectively. Patients will attend twice weekly rehabilitation sessions on site during 4 weeks, and they will continue with rehabilitation at home for five additional months. Satisfaction, assessed by the User Satisfaction Evaluation Questionnaire (USEQ), at 6 months of the VRR program initiation will be the primary outcome. Secondary outcomes include adherence, disability, spasms and spasticity, balance, fatigue, activities of daily living (ADLs), depression, anxiety, work status, cognition, demographic, and clinical characteristics (in the VRR and CR groups), and discomfort (in the VRR group). Outcome measures will be assessed at baseline, and at 1 and 6 months of rehabilitation initiation.

          Discussion: The study is intended to provide a better understanding of long-term patient satisfaction with a VRR program specifically designed for MS patients. Additionally, the study will provide information on long-term adherence, changes in motor symptoms, cognitive functions and patient-reported outcomes after the rehabilitation program. The results from this study will help to gather valuable knowledge on the use of rehabilitation with a new VR tool in MS patients.

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          Most cited references69

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          The Hospital Anxiety and Depression Scale

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            Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

            Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.
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              Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria

              The 2010 McDonald criteria for the diagnosis of multiple sclerosis are widely used in research and clinical practice. Scientific advances in the past 7 years suggest that they might no longer provide the most up-to-date guidance for clinicians and researchers. The International Panel on Diagnosis of Multiple Sclerosis reviewed the 2010 McDonald criteria and recommended revisions. The 2017 McDonald criteria continue to apply primarily to patients experiencing a typical clinically isolated syndrome, define what is needed to fulfil dissemination in time and space of lesions in the CNS, and stress the need for no better explanation for the presentation. The following changes were made: in patients with a typical clinically isolated syndrome and clinical or MRI demonstration of dissemination in space, the presence of CSF-specific oligoclonal bands allows a diagnosis of multiple sclerosis; symptomatic lesions can be used to demonstrate dissemination in space or time in patients with supratentorial, infratentorial, or spinal cord syndrome; and cortical lesions can be used to demonstrate dissemination in space. Research to further refine the criteria should focus on optic nerve involvement, validation in diverse populations, and incorporation of advanced imaging, neurophysiological, and body fluid markers.
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                Author and article information

                Contributors
                Journal
                Front Neurol
                Front Neurol
                Front. Neurol.
                Frontiers in Neurology
                Frontiers Media S.A.
                1664-2295
                21 August 2020
                2020
                : 11
                : 900
                Affiliations
                [1] 1Neurology Department, Hospital Universitario de La Princesa , Madrid, Spain
                [2] 2Medical Department, Roche Farma , Madrid, Spain
                [3] 3La Frontera , Madrid, Spain
                [4] 4Rehabilitation Department and Physiotherapy Unit, Hospital Universitario de La Princesa , Madrid, Spain
                [5] 5Biomedical Research Foundation, Hospital Universitario de La Princesa , Madrid, Spain
                [6] 6Hospital Clínico Universitario , Valladolid, Spain
                [7] 7Physical Medicine and Rehabilitation Department, Hospital Universitario de La Princesa , Madrid, Spain
                Author notes

                Edited by: Annie Jane Hill, The University of Queensland, Australia

                Reviewed by: Marino Menozzi, ETH Zürich, Switzerland; Hannes Devos, University of Kansas, United States

                *Correspondence: Virginia Meca-Lallana virmeca@ 123456hotmail.com

                This article was submitted to Neurorehabilitation, a section of the journal Frontiers in Neurology

                Article
                10.3389/fneur.2020.00900
                7580492
                33162924
                3f188c72-2337-45aa-9e63-f5b18f6cd993
                Copyright © 2020 Meca-Lallana, Prefasi, Alabarcez, Hernández, García-Vaz, Portaña, Gomis, Téllez, García-Bernáldez, Mauriño, Medrano and Vázquez-Doce.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 22 April 2020
                : 13 July 2020
                Page count
                Figures: 3, Tables: 2, Equations: 0, References: 70, Pages: 12, Words: 10287
                Categories
                Neurology
                Study Protocol

                Neurology
                rehabilitation,virtual reality,multiple sclerosis,patient satisfaction,adherence
                Neurology
                rehabilitation, virtual reality, multiple sclerosis, patient satisfaction, adherence

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