Multiple SclerosisNCT05713890
Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
A study testing Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation and Home-based landscape observation with virtual-reality for upper limb rehabilitation in people with Multiple Sclerosis, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation and Home-based landscape observation with virtual-reality for upper limb rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, Milan, 20132
Massimo Filippi, MD, 00390226433054, filippi.massimo@hsr.it
Maria A. Rocca, MD, 00390226433019, rocca.mara@hsr.it
About this study
Official title: An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis: a Clinical and Neuroimaging Study
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:
Read more
- 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
- Being tested
- Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation, Home-based landscape observation with virtual-reality for upper limb rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitationOther
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 rehabilitationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| VR-AOT | Experimental | Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation Receives: 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 Receives: Other: Home-based landscape observation with virtual-reality for upper limb rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Time required to complete the 9HPT, a measure of hand dexterity, with the left hand (average of two tests).
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in hand grip strength
Hand grip strength measured with the Jamar handheld dynamometer. Measured for left and right hand separately.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in finger tapping frequency
Number of taps performed with the index finger in 30 seconds (average of two trials). Measured for left and right hand separately.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Medical Research Council (MRC) scale
Segmental upper limb strength measured using the MRC scale. Scores on this scale range from 0 (no visible contraction) to 5 (normal strength). Measured for left and right upper limb separately.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Modified Ashworth Scale (MAS)
Upper limb spasticity (shoulder adductors, elbow flexors, wrist flexors and pronators) measured using the MAS. Scores in this scale range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Measured for left and right upper limb separately.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in items 1-6 of the Functional Independence Measure (FIM)
Autonomy in upper limb-related activities of daily living measured with items 1-6 of the FIM. Each item's score ranges from 1 (total assistance needed) to 7 (complete independence).
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Expanded Disability Status Scale (EDSS)
Multiple sclerosis-related global disability and functional systems subscores. Scores in this scale range from 0 (normal neurological function) to 10 (death due to multiple sclerosis).
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Paced Auditory Serial Addition Test (PASAT)
A cognitive task that measures sustained attention and working memory. The scores of this test, ranging from 0 to 60, are corrected for age, sex and years of education. Higher scores reflect a better performance in the test.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Symbol-Digit Modalities Test (SDMT)
A cognitive task that measures information processing speed. The scores of this test, ranging from 0 to 110, are corrected for age, sex and years of education. Higher scores reflect a better performance in the test.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
An instrument that rates the severity of depressive symptoms. It is administered by a clinician through an interview. It is composed by 10 items, each with a score ranging from 0 to 6. The overall score ranges from 0 to 60, with higher scores reflecting greater severity of depressive symptoms.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Modified Fatigue Impact Scale (MFIS)
A 21-item scale where patients rate their perceived feeling of fatigue in three subscales (physical, cognitive and psychosocial). The total score of this scale ranges from 0 to 84, with higher scores reflecting more impact of fatigue in everyday life.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Arm Function in Multiple Sclerosis Questionnaire (AMSQ)
A self-reported measure of upper limb function containing 31 items. The score of this scale ranges from 31 to 186, with higher scores indicating more limitation in hand and arm function.
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54)
A health-related measure of quality of life in people with MS. It contains 54 items grouped in 12 subscales. Two summary scores can be extracted from this scale: the physical health and mental health composite scores. These scores can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates better quality of life).
Measured: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in global brain volume
Normalized volumes of the brain, GM and WM will be extracted from 3D T1 MRI sequences.
Measured: Baseline and after 3 weeks of training
Changes in regional gray matter volumes
Tensor-based morphometry (TBM) will be used to map and compare longitudinal changes of regional GM volumes between groups
Measured: Baseline and after 3 weeks of training
Changes in white matter microstructural architecture
Tract-based spatial statistics (TBSS) will be used to map training-related changes of WM architecture.
Measured: Baseline and after 3 weeks of training
Changes in resting state functional connectivity
Independent Component Analysis will be used to decompose resting state functional MRI data into spatially independent maps and time courses, and to select the main sensory and motor functional networks of interest, as well as the Mirror Neuron System network.
Measured: Baseline and after 3 weeks of training
Changes in brain activation during an object manipulation task
Statistical Parametric Mapping (SPM) 12 will be applied to functional MRI sequences acquired during the object manipulation task to evaluate the modifications of functional activations during this task.
Measured: Baseline and after 3 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start2 Nov 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
- Investigators
- Maria A Rocca, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713890
- Sponsor's protocol ID
- RF-2021-12374941
- Status last verified
- Dec 2025
- First submitted
- 26 Jan 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset including all the data obtained from this study will be available from the Principal Investigator upon reasonable request.
Publications
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.
PubMed 18077798Rocca 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.
PubMed 30084706Rizzolatti 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.
PubMed 33910057Nuara 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.
PubMed 31115046De 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.
PubMed 34782480Jonsdottir 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.
PubMed 31352180
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis: a Clinical and Neuroimaging Study
- ClinicalTrials.gov ID
- NCT05713890
- Acronym / sponsor ID
- RF-2021-12374941
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR-AOT | Experimental | Other: Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitationHome-based Action Observation Treatment with virtual-reality for upper limb rehabilitation |
| VR-LO | Active comparator | Other: Home-based landscape observation with virtual-reality for upper limb rehabilitationHome-based landscape observation with virtual-reality for upper limb rehabilitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitationObservation 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). | Other | VR-AOT |
| Home-based landscape observation with virtual-reality for upper limb rehabilitationObservation 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). | Other | VR-LO |
Primary outcome
Change in right hand Nine-hole peg test (9HPT)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Time required to complete the 9HPT, a measure of hand dexterity, with the right hand (average of two tests).
18 secondary outcomes
Change in left hand Nine-hole peg test (9HPT)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in hand grip strength
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in finger tapping frequency
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Medical Research Council (MRC) scale
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Modified Ashworth Scale (MAS)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in items 1-6 of the Functional Independence Measure (FIM)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Expanded Disability Status Scale (EDSS)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Paced Auditory Serial Addition Test (PASAT)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Symbol-Digit Modalities Test (SDMT)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Arm Function in Multiple Sclerosis Questionnaire (AMSQ)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time frame: Baseline, after 3 weeks of training and after a 3-month follow-up
Change in global brain volume
Time frame: Baseline and after 3 weeks of training
Changes in regional gray matter volumes
Time frame: Baseline and after 3 weeks of training
Changes in white matter microstructural architecture
Time frame: Baseline and after 3 weeks of training
Changes in resting state functional connectivity
Time frame: Baseline and after 3 weeks of training
Changes in brain activation during an object manipulation task
Time frame: Baseline and after 3 weeks of training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 18077798Rocca 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: PubMed 30084706Rocca 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: PubMed 33910057Rizzolatti 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: PubMed 31115046Nuara 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: PubMed 34782480De 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: PubMed 31352180Jonsdottir 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.
- Individual participant dataSharing planned: Yes. The dataset including all the data obtained from this study will be available from the Principal Investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria A Rocca, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation and Home-based landscape observation with virtual-reality for upper limb rehabilitation in people with Multiple Sclerosis, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria A Rocca, MD (0226433019 ext. 0039, rocca.mara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in right hand Nine-hole peg test (9HPT) (time frame: Baseline, after 3 weeks of training and after a 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713890, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.