Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
NCT ID: NCT05713890
Last Updated: 2025-12-09
Study Results
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Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-11-02
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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VR-AOT
Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation
Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation
Observation of a VR scenario depicting multiple repetitions of a specific upper limb motor task belonging to typical activities of daily living, followed by mental imagination of the action observed and then by the execution of the same task, using objects provided in a kit.
In each session, patients will watch 2 different videos and will perform the two corresponding actions. The time scheduled for observation, imagery and execution of each action will be of 5, 3, and 7 minutes, respectively, so that each session will last about 30 minutes. New actions, chosen from a dataset of 50 stimuli showing progressively increasing levels of difficulty, will be weekly administered on the basis of patient's degree of motor impairment, to involve different manual skills.
30 minutes sessions, 5 times a week for 3 consecutive weeks (15 sessions in total).
VR-LO
Home-based landscape observation with virtual-reality for upper limb rehabilitation
Home-based landscape observation with virtual-reality for upper limb rehabilitation
Observation of virtually explorable landscapes followed by rest with eyes closed without focusing on any thought in particular and then execution of the same actions requested to VR-AOT-group. In each session, patients will explore 2 different landscapes and perform 2 different actions. The time scheduled for observation, rest and action execution will be of 5, 3, and 7 minutes, respectively, so that each session will last about 30 minutes.New actions, chosen from a dataset of 50 stimuli showing progressively increasing levels of difficulty, will be weekly administered on the basis of patient's degree of motor impairment, to involve different manual skills.
30 minutes sessions, 5 times a week for 3 consecutive weeks (15 sessions in total).
Interventions
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Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation
Observation of a VR scenario depicting multiple repetitions of a specific upper limb motor task belonging to typical activities of daily living, followed by mental imagination of the action observed and then by the execution of the same task, using objects provided in a kit.
In each session, patients will watch 2 different videos and will perform the two corresponding actions. The time scheduled for observation, imagery and execution of each action will be of 5, 3, and 7 minutes, respectively, so that each session will last about 30 minutes. New actions, chosen from a dataset of 50 stimuli showing progressively increasing levels of difficulty, will be weekly administered on the basis of patient's degree of motor impairment, to involve different manual skills.
30 minutes sessions, 5 times a week for 3 consecutive weeks (15 sessions in total).
Home-based landscape observation with virtual-reality for upper limb rehabilitation
Observation of virtually explorable landscapes followed by rest with eyes closed without focusing on any thought in particular and then execution of the same actions requested to VR-AOT-group. In each session, patients will explore 2 different landscapes and perform 2 different actions. The time scheduled for observation, rest and action execution will be of 5, 3, and 7 minutes, respectively, so that each session will last about 30 minutes.New actions, chosen from a dataset of 50 stimuli showing progressively increasing levels of difficulty, will be weekly administered on the basis of patient's degree of motor impairment, to involve different manual skills.
30 minutes sessions, 5 times a week for 3 consecutive weeks (15 sessions in total).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
NETWORK
IRCCS San Raffaele
OTHER
Responsible Party
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Prof. Massimo Filippi
Professor
Principal Investigators
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Maria A Rocca, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Locations
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IRCCS San Raffaele
Milan, Milan, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Jonsdottir J, Perini G, Ascolese A, Bowman T, Montesano A, Lawo M, Bertoni R. Unilateral arm rehabilitation for persons with multiple sclerosis using serious games in a virtual reality approach: Bilateral treatment effect? Mult Scler Relat Disord. 2019 Oct;35:76-82. doi: 10.1016/j.msard.2019.07.010. Epub 2019 Jul 20.
Rocca MA, Tortorella P, Ceccarelli A, Falini A, Tango D, Scotti G, Comi G, Filippi M. The "mirror-neuron system" in MS: A 3 tesla fMRI study. Neurology. 2008 Jan 22;70(4):255-62. doi: 10.1212/01.wnl.0000284667.29375.7e. Epub 2007 Dec 12.
Rocca MA, Meani A, Fumagalli S, Pagani E, Gatti R, Martinelli-Boneschi F, Esposito F, Preziosa P, Cordani C, Comi G, Filippi M. Functional and structural plasticity following action observation training in multiple sclerosis. Mult Scler. 2019 Oct;25(11):1472-1487. doi: 10.1177/1352458518792771. Epub 2018 Aug 7.
Rizzolatti G, Fabbri-Destro M, Nuara A, Gatti R, Avanzini P. The role of mirror mechanism in the recovery, maintenance, and acquisition of motor abilities. Neurosci Biobehav Rev. 2021 Aug;127:404-423. doi: 10.1016/j.neubiorev.2021.04.024. Epub 2021 Apr 25.
Nuara A, Avanzini P, Rizzolatti G, Fabbri-Destro M. Efficacy of a home-based platform for child-to-child interaction on hand motor function in unilateral cerebral palsy. Dev Med Child Neurol. 2019 Nov;61(11):1314-1322. doi: 10.1111/dmcn.14262. Epub 2019 May 21.
De Marco D, Scalona E, Bazzini MC, Nuara A, Taglione E, Lopomo NF, Rizzolatti G, Fabbri-Destro M, Avanzini P. Observation of others' actions during limb immobilization prevents the subsequent decay of motor performance. Proc Natl Acad Sci U S A. 2021 Nov 23;118(47):e2025979118. doi: 10.1073/pnas.2025979118.
Other Identifiers
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RF-2021-12374941
Identifier Type: -
Identifier Source: org_study_id
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