Actively Recruiting
Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
Led by IRCCS San Raffaele · Updated on 2025-12-09
60
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele
Lead Sponsor
I
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- Diagnosis of multiple sclerosis according to 2017 revised McDonald criteria
- Ability to understand the study purpose and provide signed informed consent
- Ability to perform virtual reality action observation treatment remotely
- Right-handed before disease onset (EHI > 50)
- Muscle strength deficit in the right upper limb (at least 1 point decrease on MRC scale)
- Activity limitation of the right hand needing help or supervision for daily tasks (per FIM items 1-6)
- Expanded Disability Status Scale (EDSS) score between 2.0 and 7.0 inclusive
- Cerebellar function score on EDSS of 1 or less
- Baseline Nine-hole peg test (9HPT) time between greater than 21 seconds and less than 180 seconds
You will not qualify if you...
- Contraindications for MRI
- Significant visual deficits preventing observation of virtual reality stimuli
- Moderate to severe pain (Visual Analog Scale score 4 or higher)
- Other neuropsychiatric or systemic diseases besides multiple sclerosis
- Clinical relapse or steroid treatment in the last 3 months
- Changes in symptomatic treatment or botulinum toxin injection in the upper limb in the last 3 months
- Stable disease-modifying treatment for multiple sclerosis for less than 6 months
- Rehabilitation treatment in the last 3 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele
Milan, Milan, Italy, 20132
Actively Recruiting
Research Team
M
Maria A Rocca, MD
CONTACT
P
Paola Valsasina, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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