Telerehabilitation in Multiple Sclerosis

Not Applicable

Active, not recruiting

• Conditions: Multiple Sclerosis

• 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

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-23
• Study Start: 2018-02-26
• Primary Completion: 2018-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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
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 outcome
Change 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 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