Clinical trial NCT03444454: Telerehabilitation in Multiple Sclerosis
Official title: The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System for Continuum of Care in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Telerehabilitation
Virtual reality
Quality of life
transcranial Direct Current Stimulation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: IRCCS Centro Neurolesi Bonino Pulejo
name: Fondazione Mondino
name: IRCCS San Camillo, Venezia, Italy
name: IRCCS San Raffaele Roma
name: Istituti Clinici Scientifici Maugeri SpA
First posted: 2018-02-23
Enrollment: 136
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS, Khymeia) compared to usual care treatment for patients with MS at home.

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)


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Multiple Sclerosis (RR and SP) based on McDonald 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:

* Existence of visual acuity and acoustic perception problems, to prevent performance of VRRS activities
* Relapses next to the time of enrolment (3 months)
* EDSS \> 6.5.

Primary outcomes:
measure: Change in measure of quality of life
timeFrame: Baseline up to 6 weeks and 6 months
Secondary outcomes:
measure: Change in balance
timeFrame: Baseline up to 6 weeks and 6 months
measure: Change in gait
timeFrame: Baseline up to 6 weeks and 6 months
measure: Change gross manual dexterity
timeFrame: Baseline up to 6 weeks and 6 months
measure: Change in global cognitive status
timeFrame: Baseline up to 6 weeks and 6 months
measure: Change cognitive status
timeFrame: Baseline up to 6 weeks and 6 months
measure: Change in fatigue
timeFrame: Baseline up to 6 weeks and 6 months
measure: Change in Emotional Traits
timeFrame: Baseline up to 6 weeks and 6 months
measure: Change in Behavioral (depression)
timeFrame: Baseline up to 6 weeks and 6 months
measure: Change in Behavioral (anxiety)
timeFrame: Baseline up to 6 weeks and 6 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs Fondazione Don Carlo Gnocchi
state: MI
Study officials:
References:
citation: 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.
citation: 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.