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

San Donato Group (GSD)

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Home-based landscape observation with virtual-reality for upper limb rehabilitation; Other: Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05713890

RF-2021-12374941

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

VR-AOT

Experimental group

Description:

Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation

Treatment:

Other: Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation

VR-LO

Active Comparator group

Description:

Home-based landscape observation with virtual-reality for upper limb rehabilitation

Treatment:

Other: Home-based landscape observation with virtual-reality for upper limb rehabilitation