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Not Yet Recruiting NCT05713890

Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis

Conditions: Multiple Sclerosis

Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 60
Sponsor: IRCCS San Raffaele

Location: Italy

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, we 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). Our 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 Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05713890). StuddyBuddy aggregates publicly available trial information.