Effectiveness of two different exergaming systems in addition to conventional treatment for physical therapy in patients with multiple sclerosis: A study protocol for a multicenter, assessor-blind, 24-week, randomized controlled trial

Abstract

Objectives: The main aim is to evaluate and compare the effectiveness of two specific exergaming systems in addition to conventional treatment on improving physical functional capacity, balance, muscle strength, spasticity in lower limbs, and quality of life in patients with multiple sclerosis. The secondary aim is to compare the effectiveness of each exergaming system to isolated conventional treatment. Design: A multicenter, assessor-blind, 24-week, randomized controlled trial. Methods: 39 patients diagnosed with multiple sclerosis will be allocated to three groups. A control group will perform a conventional treatment based on daily routine activities and/or combined training, whereas the experimental groups will be randomly divided to develop an active videogame-based exercise program through Nintendo Ring Fit Adventure© or Nintendo Wii Fit©, in addition to the conventional treatment. Study outcomes will be assessed at baseline and at 12 and 24 weeks. One-way ANOVA or Kruskal–Wallis tests will be used to analyze differences between groups at baseline and mixed ANOVA for differences between-within groups over time. Discussion: The findings from this evidence-based trial, which includes both Nintendo© active videogames, could potentially establish exergame training as a valuable and reliable therapeutic tool for neurorehabilitation. It is essential to consider the customization, specifically in our case, on each multiple sclerosis condition, and ensure patients’ adherence to the treatment.