Tele-rehabilitation Program in People With Multiple Sclerosis and Mild Disability
Key facts
- Where
- Roma, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07924410, who can take part
Where in Italy
- IRCCS San RaffaeleRoma, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele Roma
- Trial code
- NCT07924410
- Record updated
- 9 November 2026
- Original description
MS-FatigueCARE is a prospective, multicenter study aimed at investigating the mechanisms underlying fatigue in people with multiple sclerosis (MS) and mild disability, and at evaluating the efficacy of a personalized home-based telerehabilitation program. Fatigue is one of the most debilitating symptoms of MS and can significantly impact daily activities and quality of life, even in individuals with low levels of neurological disability. Current assessment relies primarily on patient-reported measures, highlighting the need for objective and sensitive fatigue biomarkers.Read full original descriptionShow less
Exploring Mechanisms and Fatigue Management Strategies Through a Tele-rehabilitation Program in People With Multiple Sclerosis and Mild Disability
MS-FatigueCARE is a prospective, multicenter study aimed at investigating the mechanisms underlying fatigue in people with multiple sclerosis (MS) and mild disability, and at evaluating the efficacy of a personalized home-based telerehabilitation program. Fatigue is one of the most debilitating symptoms of MS and can significantly impact daily activities and quality of life, even in individuals with low levels of neurological disability. Current assessment relies primarily on patient-reported measures, highlighting the need for objective and sensitive fatigue biomarkers.
The study comprises two complementary phases. Phase 1 is a cross-sectional observational study comparing people with relapsing-remitting MS and mild disability (EDSS score 0-3.5) with healthy controls. The objective is to investigate the relationship between perceived fatigue and objective physiological and motor parameters, focusing specifically on oxygen consumption (VO₂), the metabolic cost of walking (CW), postural control, and gait-related parameters. In participants with MS, the potential association between fatigue and Epstein-Barr virus (EBV) serological status or reactivation will also be examined.
Phase 2 is a single-blind, randomized controlled crossover study involving MS participants who completed Phase 1. Participants will be randomly assigned to either a six-week multidomain telerehabilitation program-based on non-immersive virtual reality and "serious games"-or a self-managed therapeutic education program. The telerehabilitation intervention integrates motor, cognitive, and cardiorespiratory exercises to be performed at home four times a week for 60 minutes, with remote monitoring by rehabilitation professionals. After a six-week washout period, participants will switch to the alternative intervention. The primary outcome is the energy cost of walking, measured during the 6-Minute Walking Test. Secondary outcomes include subjective fatigue, cognitive and psychological functioning, walking and balance performance, quality of life, usability, and treatment adherence, as well as instrumental measures of VO₂/VCO₂, postural control, and lower-limb kinematics.
Overall, MS-FatigueCARE aims to identify objective markers of fatigue and determine whether a personalized, multi-domain telerehabilitation approach can reduce fatigue and improve functional outcomes and quality of life for people with MS, while fostering accessible and continuous rehabilitative care.
Inclusion: Individuals diagnosed with relapsing-remitting MS (RRMS); Age between 18 and 65 years; EDSS (Expanded Disability Status Scale) score between 0 and 3.5; No fixed or stable pharmacological therapy; Three months since the last relapse; Self-reported persistent fatigue with a significant impact on daily life, assessed using a Visual Analogue Scale (VAS) for fatigue impact, with a score >20 indicating moderate to severe fatigue; Ability to understand and sign the informed consent for the study; Ability to perform the study procedures.
Exclusion: Evidence of clinical relapses and/or steroid treatment (within 6 months prior to study start); Severe cardiorespiratory disease; Severe visual impairment; Severe joint and/or bone disorders interfering with balance and gait (based on clinical judgment); Individuals diagnosed with major depression (DSM-5); Recent Botulinum Toxin injection in the affected upper limb, or such an injection planned for the duration of the study; Interruption of treatment for 1 week or 5 consecutive sessions; Participation in other interventional studies aimed at fatigue management; Inability to adhere to the exercise program due to poor compliance.