Effect of an interactive Pilates-based telerehabilitation intervention in people with multiple sclerosis: Protocol for a Randomized Controlled Trial. (Preprint)

Abstract

Multiple Sclerosis (MS) progressively worsens over time, leading to cumulative physical disability, cognitive deficits, and other symptoms that prevent people with MS (PwMS) from performing daily living activities correctly and regularly. Recently, physical activity (PA) has been recommended in MS to maintain good physical fitness and mental health, reduce symptoms severity and risk of relapse, and improve quality of life. In this context, Pilates has been suggested as an ideal PA to manage physical, cognitive and psychological MS symptoms and a method useful to maintain and improve balance and gait.

This paper presents the protocol for a study that aims to assess the efficacy on the physical domain, specifically balance and gait, of an at-home self-managed PA intervention delivered through the MS-FIT exergame. Additionally, measures of cognitive performances, quality of life (QoL) and wellbeing will be considered.

This is a multicentre 2-arm randomized controlled trial with three assessment points (baseline, post-intervention at 12 weeks, and follow-up at 6 weeks). PwMS with mild disability, low fall risk, preserved cognitive functions and low anxiety and depression are potential eligible participants. Participants in the experimental group (MS-FIT) will receive access to MS-FIT exergame for at-home self-administration in addition to their leisure time physical activities. MS-FIT is a tool for an individual interactive game-based training using Microsoft Kinect Sensor V2. It implements Pilates exercises appropriately adapted to MS requirements. Participants in the control group (CTRL) will only have access to their leisure time physical activities. Subjects in the MS-FIT group will train at home with MS-FIT for 12 weeks and they will be required to perform the exercises for a total of 30 minutes/day for at least 3 days/week. The primary outcome is the Timed Up and Go, a test deputed to assess ambulation. We will also administer other tests for the motor function and for cognition, fatigue, quality of life, wellbeing, and PA. Acceptance and satisfaction towards the received intervention and the subjective impression of changes in performances will be assessed with dedicated questionnaires.

Recruitment for the trial started on March 16, 2022, and the first participant was randomized on the same day. Data analysis and results are aimed to be published in early 2025.

Cumulative data suggest that Pilates has verified benefits in several neurological diseases and can be a PA tool for PwMS. With this study we will provide evidence for a use in the clinical practice of a digital tool for self-administration of Pilates exercises at home as a complement of rehabilitation and for the continuity-of-care of PwMS.

ClinicalTrials.gov (number ID: NCT04011579)