NCT03444454

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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

February 2, 2018

Last Update Submit

May 2, 2024

Conditions

Multiple Sclerosis

Keywords

TelerehabilitationVirtual realityQuality of lifetranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in measure of quality of life

    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 Outcomes (9)

  • Change in balance

    Baseline up to 6 weeks and 6 months

  • Change in gait

    Baseline up to 6 weeks and 6 months

  • Change gross manual dexterity

    Baseline up to 6 weeks and 6 months

  • Change in global cognitive status

    Baseline up to 6 weeks and 6 months

  • Change cognitive status

    Baseline up to 6 weeks and 6 months

  • +4 more secondary outcomes

Study Arms (4)

VRRS Khymeia

EXPERIMENTAL

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

Usual care program

ACTIVE COMPARATOR

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

VRRS Khymeia plus active tDCS

EXPERIMENTAL

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

VRRS Khymeia plus placebo tDCS

ACTIVE COMPARATOR

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

Interventions

VRRS KhymeiaBEHAVIORAL

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.

VRRS Khymeia
Usual care programBEHAVIORAL

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

Usual care program
VRRS Khymeia plus active tDCSBEHAVIORAL

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.

VRRS Khymeia plus active tDCS
VRRS Khymeia plus placebo tDCSBEHAVIORAL

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.

VRRS Khymeia plus placebo tDCS

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Fondazione Don Carlo Gnocchi

Milan, MI, 20148, Italy

Location

Related Publications (2)

  • Di Tella S, Pagliari C, Blasi V, Mendozzi L, Rovaris M, Baglio F. Integrated telerehabilitation approach in multiple sclerosis: A systematic review and meta-analysis. J Telemed Telecare. 2020 Aug-Sep;26(7-8):385-399. doi: 10.1177/1357633X19850381. Epub 2019 May 27.

    PMID: 31132909BACKGROUND

  • Pagliari C, Di Tella S, Jonsdottir J, Mendozzi L, Rovaris M, De Icco R, Milanesi T, Federico S, Agostini M, Goffredo M, Pellicciari L, Franceschini M, Cimino V, Bramanti P, Baglio F. Effects of home-based virtual reality telerehabilitation system in people with multiple sclerosis: A randomized controlled trial. J Telemed Telecare. 2024 Feb;30(2):344-355. doi: 10.1177/1357633X211054839. Epub 2021 Dec 1.

    PMID: 34851211DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, researcher

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 23, 2018

Study Start

February 26, 2018

Primary Completion

December 31, 2018

Study Completion

June 30, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations

IT(1)