Multiple Sclerosis
Conditions
Keywords
Telerehabilitation, Virtual reality, Quality of life, transcranial Direct Current Stimulation
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)
Interventions
BEHAVIORALVRRS 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.
BEHAVIORALUsual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
BEHAVIORALVRRS 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.
BEHAVIORALVRRS 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.
Sponsors
IRCCS Centro Neurolesi Bonino Pulejo
Fondazione Mondino
IRCCS San Camillo, Venezia, Italy
IRCCS San Raffaele Roma
Istituti Clinici Scientifici Maugeri SpA
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in measure of quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in gait | Baseline up to 6 weeks and 6 months | 12-item Multiple Sclerosis Walking Scale |
| Change gross manual dexterity | Baseline up to 6 weeks and 6 months | Box and Block Test |
| Change in global cognitive status | Baseline up to 6 weeks and 6 months | Montreal Cognitive Assessment (MoCA) test |
| Change cognitive status | Baseline up to 6 weeks and 6 months | Symbol Digit Modalities Test (Form Brief Repeatable Battery of Neuropsychological Tests ) |
| Change in balance | Baseline up to 6 weeks and 6 months | Mini-Balance Evalutation System (mini-BES) Test |
| Change in Emotional Traits | Baseline up to 6 weeks and 6 months | The Regulatory Emotional Self-Efficacy (RESE) scale The RESE scale assesses self-efficacy in expressing positive emotions and self-efficacy in managing negative emotions. With this scale, participants rate (ranging from 1 \[not well at all\] to 5 \[very well\]) their capability to manage their emotional life. RESE scale consists of 12 items and are calculated 3 scores: 1) self-efficacy in expressing positive emotions (POS) score; 2)self-efficacy in managing negative emotions (NEG) score; 3)self-efficacy in managing despondency/distress (DES) score Higher values within each score represent a better outcome |
| Change in Behavioral (depression) | Baseline up to 6 weeks and 6 months | Beck Depression Inventory |
| Change in Behavioral (anxiety) | Baseline up to 6 weeks and 6 months | State-trait anxiety inventory |
| Change in fatigue | Baseline up to 6 weeks and 6 months | Fatigue Severity Scale A questionnaire with 9 items (questions) Grading of each FSS item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items Higher values represent a worse outcome |
Countries
Italy
Outcome results
None listed