Telerehabilitation in Multiple Sclerosis

May 2, 2024 updated by: Francesca Baglio, Fondazione Don Carlo Gnocchi Onlus

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20148
        • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: VRRS 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.
Active Comparator: Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
Behavioral: Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
Experimental: 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
Behavioral: VRRS 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.
Active Comparator: 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
Behavioral: VRRS 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in measure of quality of life
Time Frame: 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
Baseline up to 6 weeks and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in balance
Time Frame: Baseline up to 6 weeks and 6 months
Mini-Balance Evalutation System (mini-BES) Test
Baseline up to 6 weeks and 6 months
Change in gait
Time Frame: Baseline up to 6 weeks and 6 months
12-item Multiple Sclerosis Walking Scale
Baseline up to 6 weeks and 6 months
Change gross manual dexterity
Time Frame: Baseline up to 6 weeks and 6 months
Box and Block Test
Baseline up to 6 weeks and 6 months
Change in global cognitive status
Time Frame: Baseline up to 6 weeks and 6 months
Montreal Cognitive Assessment (MoCA) test
Baseline up to 6 weeks and 6 months
Change cognitive status
Time Frame: Baseline up to 6 weeks and 6 months
Symbol Digit Modalities Test (Form Brief Repeatable Battery of Neuropsychological Tests )
Baseline up to 6 weeks and 6 months
Change in fatigue
Time Frame: 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
Baseline up to 6 weeks and 6 months
Change in Emotional Traits
Time Frame: 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
Baseline up to 6 weeks and 6 months
Change in Behavioral (depression)
Time Frame: Baseline up to 6 weeks and 6 months
Beck Depression Inventory
Baseline up to 6 weeks and 6 months
Change in Behavioral (anxiety)
Time Frame: Baseline up to 6 weeks and 6 months
State-trait anxiety inventory
Baseline up to 6 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

IRCCS San Camillo, Venezia, Italy
Istituti Clinici Scientifici Maugeri SpA
IRCCS San Raffaele Roma
IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT)
IRCCS Fondazione Istituto Neurologico Casimiro Mondino, Pavia (IT)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FdG_VRRS_MS_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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