Telerehabilitation in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Usual care programBehavioral: VRRS KhymeiaBehavioral: VRRS Khymeia plus active tDCSBehavioral: VRRS Khymeia plus placebo tDCS
- Registration Number
- NCT03444454
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 136
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care program 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 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 plus active tDCS 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 placebo tDCS 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change gross manual dexterity Baseline up to 6 weeks and 6 months Box and Block Test
Change in balance Baseline up to 6 weeks and 6 months Mini-Balance Evalutation System (mini-BES) 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 Behavioral (anxiety) Baseline up to 6 weeks and 6 months State-trait anxiety inventory
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 outcomeChange in global cognitive status Baseline up to 6 weeks and 6 months Montreal Cognitive Assessment (MoCA) test
Change in gait Baseline up to 6 weeks and 6 months 12-item Multiple Sclerosis Walking Scale
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 outcomeChange in Behavioral (depression) Baseline up to 6 weeks and 6 months Beck Depression Inventory
Trial Locations
- Locations (1)
Irccs Fondazione Don Carlo Gnocchi
🇮🇹Milano, MI, Italy