An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis: a Clinical and Neuroimaging Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS San Raffaele
RECRUITING
Milan
Contact Information
Primary
Maria A Rocca, MD
rocca.mara@hsr.it
0226433019
Backup
Paola Valsasina, MSc
valsasina.paola@hsr.it
0226433944
Time Frame
Start Date: 2023-11-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: VR-AOT
Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation
Active_comparator: VR-LO
Home-based landscape observation with virtual-reality for upper limb rehabilitation
Related Therapeutic Areas
Sponsors
Collaborators: Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov