Telerehabilitation in Multiple Sclerosis

The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System for Continuum of Care in Multiple Sclerosis

Status unknownNot a drug-phase studyMS (type not specified)NCT03444454

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • VRRS Khymeia
  • VRRS Khymeia plus active tDCS

Compared with

  • Usual care program

Placebo

  • VRRS Khymeia plus placebo tDCS

What it measured

Main measures

  • Change in measure of quality of life

    Baseline up to 6 weeks and 6 months

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)

Other measures (9)

  • Change in balance

    Baseline up to 6 weeks and 6 months

    Walking and mobility

  • Change in gait

    Baseline up to 6 weeks and 6 months

    Walking and mobility

  • Change gross manual dexterity

    Baseline up to 6 weeks and 6 months

    Arm and hand function

  • Change in global cognitive status

    Baseline up to 6 weeks and 6 months

    Thinking and memory

  • Change cognitive status

    Baseline up to 6 weeks and 6 months

    Thinking and memory

  • Change in fatigue

    Baseline up to 6 weeks and 6 months

    Fatigue

  • Change in Emotional Traits

    Baseline up to 6 weeks and 6 months

  • Change in Behavioral (depression)

    Baseline up to 6 weeks and 6 months

    Mood and sleep

  • Change in Behavioral (anxiety)

    Baseline up to 6 weeks and 6 months

    Mood and sleep

Who could take part

MS (type not specified) · 25 to 70

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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)

Papers

Loading reviews and guidelines…

History

    1. Started

      Feb 2018

    2. Main results due

      Dec 2018

    3. Finished

      Jun 2024

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