Protocol for a pilot effectiveness and feasibility randomized controlled trial of an advanced telerehabilitation system for people with multiple sclerosis (PLATINUMS project)

Abstract

Background Multiple Sclerosis (MS) causes many different symptoms, with some of the most dominant being impaired balance and walking performance. Exercise effectively improves strength, balance, and walking performance, but barriers to performing exercise, such as fatigue and logistical issues, do exist. A potential strategy to overcome these barriers is the use of telerehabilitation, which has shown promising results. Few previous studies have measured strength, balance, and walking outcomes, and none have used systems that provided real-time feedback. Therefore, the present study aims to compare telerehabilitation to a paper-based home-based exercise program to evaluate the effectiveness on strength, balance, and walking outcomes. The telehealth intervention will be delivered through an innovative platform that uses Artificial Intelligence algorithms to provide users and clinicians with tailored feedback on performance and adherence. Methods This study is a multinational, feasibility, pilot randomised controlled trial investigating the effects of an AI-based telerehabilitation intervention in persons with multiple sclerosis (pwMS). Participants (n = 96) will be randomised to receive either 10 weeks of a home-based AI telerehabilitation intervention or a home-based exercise intervention with paper-based instructions. The primary clinical outcome is the 30-second sit-to-stand test (30STS), and secondary clinical outcomes are balance, fatigue, MS impact, quality of life, symptoms of anxiety and depression, and cost-effectiveness analyses. Feasibility, in terms of recruitment and retention, the acceptability of procedures, and compliance and adherence, will also be captured. Trial registration ClinicalTrials.gov NCT07310914