Telerehabilitation in Multiple Sclerosis

Don Carlo Gnocchi Onlus Foundation

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Behavioral: VRRS Khymeia plus placebo tDCS; Behavioral: VRRS Khymeia; Behavioral: VRRS Khymeia plus active tDCS; Behavioral: Usual care program

Study type: Interventional

Funder types: Other

Identifiers

NCT03444454

FdG_VRRS_MS_01

Details and patient eligibility

About

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)

Enrollment: 136 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 4 patient groups

VRRS Khymeia

Experimental group

Description:

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.

Treatment:

Behavioral: VRRS Khymeia

Usual care program

Active Comparator group

Description:

The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.

Treatment:

Behavioral: Usual care program

VRRS Khymeia plus active tDCS

Experimental group

Description:

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

Treatment:

Behavioral: VRRS Khymeia plus active tDCS

VRRS Khymeia plus placebo tDCS

Active Comparator group

Description:

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

Treatment:

Behavioral: VRRS Khymeia plus placebo tDCS