Home-based Action Observation Treatment With Virtual-reality for Arm R
An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis: a Clinical and Neuroimaging Study
What it found
No result yet.
What was tested
Treatment tested
- Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation
Compared with
- Home-based landscape observation with virtual-reality for upper limb rehabilitation
What it measured
Main measures
Change in right hand Nine-hole peg test (9HPT)
Baseline, after 3 weeks of training and after a 3-month follow-up
Disability progressionArm and hand function
Other measures (18)
Change in left hand Nine-hole peg test (9HPT)
Baseline, after 3 weeks of training and after a 3-month follow-up
Disability progressionArm and hand functionChange in hand grip strength
Baseline, after 3 weeks of training and after a 3-month follow-up
Arm and hand functionPhysical functionChange in finger tapping frequency
Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Medical Research Council (MRC) scale
Baseline, after 3 weeks of training and after a 3-month follow-up
Arm and hand functionPhysical functionChange in Modified Ashworth Scale (MAS)
Baseline, after 3 weeks of training and after a 3-month follow-up
Arm and hand functionSpasticityChange in items 1-6 of the Functional Independence Measure (FIM)
Baseline, after 3 weeks of training and after a 3-month follow-up
Arm and hand functionChange in Expanded Disability Status Scale (EDSS)
Baseline, after 3 weeks of training and after a 3-month follow-up
Disability progressionChange in Paced Auditory Serial Addition Test (PASAT)
Baseline, after 3 weeks of training and after a 3-month follow-up
Thinking and memoryChange in Symbol-Digit Modalities Test (SDMT)
Baseline, after 3 weeks of training and after a 3-month follow-up
Thinking and memoryChange in Montgomery-Asberg Depression Rating Scale (MADRS)
Baseline, after 3 weeks of training and after a 3-month follow-up
Mood and sleep
Who could take part
MS (type not specified) · 18 to 65 · EDSS 2.0 to 7.0
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.
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History
Started
Nov 2023
Main results due
Sept 2026
Finished
Dec 2026