Home-based virtual-reality arm training for people with multiple sclerosis
Tests home virtual-reality action observation training to improve arm movement in multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
Key facts
- Where
- Milan, 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: NCT05713890, who can take part
Where in Italy
- IRCCS San RaffaeleMilan, ItalyTaking people
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
- Trial code
- NCT05713890
- Record updated
- 9 December 2025
- Original description
Action Observation Treatment (AOT) is a rehabilitative strategy which has been proposed as a promising approach to improve motor performance in neurological conditions, including multiple sclerosis (MS).Read full original descriptionShow less
An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis: a Clinical and Neuroimaging Study
Action Observation Treatment (AOT) is a rehabilitative strategy which has been proposed as a promising approach to improve motor performance in neurological conditions, including multiple sclerosis (MS).
In this clinical trial, the investigators aim to explore the role of a home-based AOT with virtual reality (VR) in improving upper limb motor function in people with MS (PwMS). The objectives are:
* To compare the effects of home-based VR-AOT versus VR-landscape observation (LO) on upper limb motor performance; * To measure brain network functional changes (functional plasticity) and structural variations of gray matter (GM) and white matter (WM) (structural plasticity) using advanced magnetic resonance imaging (MRI) techniques following VR-AOT and VR-LO; * To study the correlations between MRI changes and clinical improvements and the predictors of VR-AOT efficacy.
All participants will undergo treatment sessions for 3 weeks (5 consecutive days/week, total=15 sessions lasting 30 minutes each). Those in the VR-AOT group will observe, imagine and execute two upper limb motor tasks in each session. Those in the VR-LO group will perform the same tasks, but they will observe inanimate landscapes beforehand instead.
Inclusion: Age 18-65 years; Diagnosis of MS according to 2017 revised McDonald criteria; Ability to understand the purpose and risks of the study and provide signed informed consent; Ability to remotely perform VR-AOT; Right pre-morbid handedness (EHI>50); Muscle strength deficit involving the right upper limb (≥1 point decrease of MRC scale); Presence of activity limitation of the right hand (need of adaptations, supervision or help by another person for the execution of daily living activities according to items 1-6 of the FIM); EDSS score 2.0-7.0 (inclusive); Cerebellar functional system score of the EDSS ≤1; Baseline 9HPT score >21 seconds and <180 seconds.
Exclusion: Concomitant neuro-psychiatric or systemic diseases (other than MS); Clinical relapses or steroid treatment in the past 3 months; Stable disease-modifying treatment for MS for ≤6 months; MRI contraindications; Significant visual deficits not allowing to observe VR stimuli; Moderate to severe pain disturbances (VAS≥4); Modification of symptomatic treatment or botulin toxin injection in the upper limb in the past 3 months; Rehabilitation treatment in the past 3 months.