Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
136 participants
INTERVENTIONAL
2018-02-26
2024-06-30
Brief Summary
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The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care training. The investigators will assess the effect of VRRS system on the quality of life, motor, and cognitive abilities. (Phase I) In the second phase of the present study we aim to evaluate the effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (lDLPFC) combined with VRRS compared to placebo tDCS stimulation combined with VRRS. The effects of the intervention patient-relevant outcomes will be assessed using a randomized controlled trial design with four groups. The investigators will assess the effect of VRRS system on patient-relevant outcomes motor, cognitive and participation. (Phase II)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VRRS Khymeia
The group will receive a kit home-based (a tablet home, an exercise equipment, access to a daily individualized training program).
The exercise program will be remotely charged by therapist on the patient's computer.
Each patient's performed session will be reviewed remotely by the therapist.
VRRS Khymeia
Participants will receive an individualized exercise program set up by the therapist. The intervention applied to the experimental group will consist of 30 sessions of Khymeia VRRS training distributed in five sessions for week, each lasting 45 minutes.
Each session is constructed by alternating physical with cognitive activities. The sessions will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
VRRS Khymeia plus active tDCS
The group will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training
VRRS Khymeia plus active tDCS
Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training.
The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
VRRS Khymeia plus placebo tDCS
The group will receive 5 sessions of an individualized home-based VRRS training combined with placebo tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training
VRRS Khymeia plus placebo tDCS
Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training.
The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
Interventions
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VRRS Khymeia
Participants will receive an individualized exercise program set up by the therapist. The intervention applied to the experimental group will consist of 30 sessions of Khymeia VRRS training distributed in five sessions for week, each lasting 45 minutes.
Each session is constructed by alternating physical with cognitive activities. The sessions will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
VRRS Khymeia plus active tDCS
Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training.
The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
VRRS Khymeia plus placebo tDCS
Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training.
The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
Eligibility Criteria
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Inclusion Criteria
* Education ≥ 8 ages
* Italian mother language
* Right-handedness
* Use of corticosteroids for three months prior to the study, having and no acute exacerbations of symptoms within three months of the study.
Exclusion Criteria
* Relapses next to the time of enrolment (3 months)
* EDSS \> 6.5.
25 Years
70 Years
ALL
No
Sponsors
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IRCCS Centro Neurolesi Bonino Pulejo
OTHER
Fondazione Mondino
OTHER
IRCCS San Camillo, Venezia, Italy
OTHER
IRCCS San Raffaele Roma
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Francesca Baglio
MD, researcher
Locations
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Irccs Fondazione Don Carlo Gnocchi
Milan, MI, Italy
Countries
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References
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Di Tella S, Pagliari C, Blasi V, Mendozzi L, Rovaris M, Baglio F. Integrated telerehabilitation approach in multiple sclerosis: A systematic review and meta-analysis. J Telemed Telecare. 2020 Aug-Sep;26(7-8):385-399. doi: 10.1177/1357633X19850381. Epub 2019 May 27.
Pagliari C, Di Tella S, Jonsdottir J, Mendozzi L, Rovaris M, De Icco R, Milanesi T, Federico S, Agostini M, Goffredo M, Pellicciari L, Franceschini M, Cimino V, Bramanti P, Baglio F. Effects of home-based virtual reality telerehabilitation system in people with multiple sclerosis: A randomized controlled trial. J Telemed Telecare. 2024 Feb;30(2):344-355. doi: 10.1177/1357633X211054839. Epub 2021 Dec 1.
Other Identifiers
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FdG_VRRS_MS_01
Identifier Type: -
Identifier Source: org_study_id
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