NCT05713890Recruiting
Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis: a Clinical and Neuroimaging Study
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 26 Jan 2023
- Start date
- 2 Nov 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Multiple sclerosis
- NCT number
- NCT05713890
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 2 Nov 2023 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant neuro-psychiatric or systemic diseases (other than MS);
- Clinical relapses or steroid treatment in the past 3 months;
Other illness
- Stable disease-modifying treatment for MS for ≤6 months;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.