Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
Recruiting · NCT05713890 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- MRI contraindications;
- Significant visual deficits not allowing to observe VR stimuli;
- Moderate to severe pain disturbances (VAS≥4);
- Concomitant neuro-psychiatric or systemic diseases (other than MS);
- Clinical relapses or steroid treatment in the past 3 months;
- Modification of symptomatic treatment or botulin toxin injection in the upper limb in the past 3 months;
- Stable disease-modifying treatment for MS for ≤6 months;
- Rehabilitation treatment in the past 3 months.
Where it is running
1 location listed.
- IRCCS San Raffaele - Milan, Milan, Italy