Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitationOther: Home-based landscape observation with virtual-reality for upper limb rehabilitation
- Registration Number
- NCT05713890
- Lead Sponsor
- IRCCS San Raffaele
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 VR-LO Home-based landscape observation with virtual-reality for upper limb rehabilitation Home-based landscape observation with virtual-reality for upper limb rehabilitation
- Primary Outcome Measures
Name Time Method Change in right hand Nine-hole peg test (9HPT) 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).
- Secondary Outcome Measures
Name Time Method Change in finger tapping frequency Baseline, after 3 weeks of training and after a 3-month follow-up Number of taps performed with the index finger in 30 seconds (average of two trials). Measured for left and right hand separately.
Change in Expanded Disability Status Scale (EDSS) Baseline, after 3 weeks of training and after a 3-month follow-up 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).
Change in Symbol-Digit Modalities Test (SDMT) Baseline, after 3 weeks of training and after a 3-month follow-up 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.
Changes in regional gray matter volumes Baseline and after 3 weeks of training Tensor-based morphometry (TBM) will be used to map and compare longitudinal changes of regional GM volumes between groups
Change in left hand Nine-hole peg test (9HPT) 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 left hand (average of two tests).
Change in Modified Ashworth Scale (MAS) Baseline, after 3 weeks of training and after a 3-month follow-up 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.
Change in items 1-6 of the Functional Independence Measure (FIM) Baseline, after 3 weeks of training and after a 3-month follow-up 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).
Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54) Baseline, after 3 weeks of training and after a 3-month follow-up 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).
Changes in white matter microstructural architecture Baseline and after 3 weeks of training Tract-based spatial statistics (TBSS) will be used to map training-related changes of WM architecture.
Changes in brain activation during an object manipulation task Baseline and after 3 weeks of training 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.
Change in hand grip strength Baseline, after 3 weeks of training and after a 3-month follow-up Hand grip strength measured with the Jamar handheld dynamometer. Measured for left and right hand separately.
Change in Paced Auditory Serial Addition Test (PASAT) Baseline, after 3 weeks of training and after a 3-month follow-up 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.
Change in Medical Research Council (MRC) scale Baseline, after 3 weeks of training and after a 3-month follow-up 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.
Change in Modified Fatigue Impact Scale (MFIS) Baseline, after 3 weeks of training and after a 3-month follow-up 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.
Change in Arm Function in Multiple Sclerosis Questionnaire (AMSQ) Baseline, after 3 weeks of training and after a 3-month follow-up 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.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Baseline, after 3 weeks of training and after a 3-month follow-up 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.
Change in global brain volume Baseline and after 3 weeks of training Normalized volumes of the brain, GM and WM will be extracted from 3D T1 MRI sequences.
Changes in resting state functional connectivity Baseline and after 3 weeks of training 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.
Trial Locations
- Locations (1)
IRCCS San Raffaele
🇮🇹Milan, Italy