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

NCT05713890 | Recruiting DMC

• 1 other identifier: RF-2021-12374941
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in right hand Nine-hole peg test (9HPT)

  Time required to complete the 9HPT, a measure of hand dexterity, with the right hand (average of two tests).

  Baseline, after 3 weeks of training and after a 3-month follow-up

Secondary Outcomes (18)

• Change in left hand Nine-hole peg test (9HPT)

  Baseline, after 3 weeks of training and after a 3-month follow-up

• Change in hand grip strength

  Baseline, after 3 weeks of training and after a 3-month follow-up

• Change 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

• Change in Modified Ashworth Scale (MAS)

  Baseline, after 3 weeks of training and after a 3-month follow-up

Study Arms (2)

VR-AOT

EXPERIMENTAL

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

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

VR-LO

ACTIVE COMPARATOR

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

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

Interventions

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

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-AOT

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

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).

VR-LO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Istituto di Neuroscienze Consiglio Nazionale delle Ricerche: collaborator

Study Sites (1)

IRCCS San Raffaele

Milan, Milan, 20132, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 18077798 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.

  PMID: 30084706 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.

  PMID: 33910057 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.

  PMID: 31115046 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.

  PMID: 34782480 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.

  PMID: 31352180 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maria A Rocca, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria A Rocca, MD

CONTACT

0226433019; rocca.mara@hsr.it

Paola Valsasina, MSc

CONTACT

0226433944; valsasina.paola@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors (neurologists, physiotherapists and neuropsychologists) will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized, controlled, single-blinded, parallel study. A total sample size of 60 PwMS is planned, with 30 participants randomly assigned to each of the treatment arms (ratio 1:1) through a computer-generated list managed by a physician external to the study.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The dataset including all the data obtained from this study will be available 6 months after the publication of the results.
• Access Criteria: The dataset including all the data obtained from this study will be available from the Principal Investigator upon reasonable request.

Locations

IT (1)