The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System for Continuum of Care in Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Change in measure of quality of life
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in measure of quality of life
Time Frame: Baseline up to 6 weeks and 6 months
Quality of life will be measured by 54-item Multiple Sclerosis Quality of Life (MSQOL-54) questionnaire There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In addition, there are 12 subscales: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. There are also two single-item measures: satisfaction with sexual function and change in health. Administration forms and scoring instructions can be downloaded (https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/MSQOL54\_995.pdf ). Higher values represent a better outcome
Secondary Outcomes
- Change gross manual dexterity(Baseline up to 6 weeks and 6 months)
- Change in balance(Baseline up to 6 weeks and 6 months)
- Change cognitive status(Baseline up to 6 weeks and 6 months)
- Change in Behavioral (anxiety)(Baseline up to 6 weeks and 6 months)
- Change in Emotional Traits(Baseline up to 6 weeks and 6 months)
- Change in global cognitive status(Baseline up to 6 weeks and 6 months)
- Change in gait(Baseline up to 6 weeks and 6 months)
- Change in fatigue(Baseline up to 6 weeks and 6 months)
- Change in Behavioral (depression)(Baseline up to 6 weeks and 6 months)
Investigators
Francesca Baglio
MD, researcher
Fondazione Don Carlo Gnocchi Onlus