Home-based exoskeleton use to improve quality of life in patients with multiple sclerosis: study protocol of a multicentre, randomised, cross-over trial

Background

Multiple sclerosis (MS) frequently leads to mobility impairment, fatigue and a significant decline in health-related quality of life (QoL). Home-based assistive technology, such as robotic exoskeletons, offers a promising solution to enhance independent mobility and increase the intensity of motor training. Long-term functional and quality of life benefits of light lower-limb exoskeleton home use have yet to be determined.

Objective

The primary objective of this study is to determine the efficacy of an 8-week period, home-based use of a robotic exoskeleton in improving QoL in individuals with MS, compared with a no-device control period.

Methods

This is a multicentre, randomised, controlled and single-blinded cross-over trial. A total of 28 patients with confirmed MS (Expanded Disability Status Scale (EDSS) score 5.0–7.0) will be recruited across three rehabilitation centres. Participants will be randomly assigned to two 8-week phases: intervention (daily home-based exoskeleton use) or control (physical activity advice), separated by an 8-week wash-out period. The primary outcome is the change in the MS Quality of Life assessed by the Functional Assessment of Multiple Sclerosis (FAMS) physical composite score from baseline to the end of each phase. Secondary outcomes include changes in walking performance (2-minute Walk, 10 M Walk, Timed Up-and-Go, Four Square Step Test and Sit-to-Stand Test), fatigue severity (Fatigue Severity Scale and Fatigue Impact Measurement Scale (EMIF)-MS), and strength capacity (Manual Muscle Testing, Tardieu scale), self-confidence (Rosenberg), anxiety and depression (Hospital Anxiety and Depression Scale), satisfaction to use (Technical Aid Satisfaction Scale) and intention to use (Unified Theory of Acceptance and Use of Technology).

Ethics and dissemination

This study was registered on ClinicalTrials.gov on 1 February 2024 (Trial registration number: NCT05835622 https://clinicaltrials.gov/ct2/show/ NCT05835622). Patient recruitment is currently underway and is anticipated to be completed by January 2026. Primary endpoint data collection is expected to be completed in June 2026.

This study protocol describes a rigorous trial designed to provide high-level evidence on the impact of a home-based robotic exoskeleton on QoL in individuals with MS. By determining intervention effectiveness, the results will provide clinical guidelines, potentially facilitating the widespread adoption of home-based assistive robotics to substantially improve the independence and overall QoL for patients with MS.

Trial registration number

NCT05835622 .