Multiple SclerosisNCT03444454
Telerehabilitation in Multiple Sclerosis
A study testing VRRS Khymeia and VRRS Khymeia plus active tDCS in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- VRRS Khymeia and VRRS Khymeia plus active tDCS
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteItaly
- Study dates
- 26 Feb 2018to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Conditions
- Multiple Sclerosis
- Being tested
- VRRS Khymeia, Usual care program, VRRS Khymeia plus active tDCS, VRRS Khymeia plus placebo tDCS
- Keywords
- Telerehabilitation, Virtual reality, Quality of life, transcranial Direct Current Stimulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRRS KhymeiaBehavioural
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.
Usual care programBehavioural
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
VRRS Khymeia plus active tDCSBehavioural
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 tDCSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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 Receives: Behavioral: VRRS Khymeia plus placebo tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline up to 6 weeks and 6 months
Secondary outcomes (9)
Change in balance
Mini-Balance Evalutation System (mini-BES) Test
Measured: Baseline up to 6 weeks and 6 months
Change in gait
12-item Multiple Sclerosis Walking Scale
Measured: Baseline up to 6 weeks and 6 months
Change gross manual dexterity
Box and Block Test
Measured: Baseline up to 6 weeks and 6 months
Change in global cognitive status
Montreal Cognitive Assessment (MoCA) test
Measured: Baseline up to 6 weeks and 6 months
Change cognitive status
Symbol Digit Modalities Test (Form Brief Repeatable Battery of Neuropsychological Tests )
Measured: Baseline up to 6 weeks and 6 months
Change in fatigue
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
Measured: Baseline up to 6 weeks and 6 months
Change in Emotional Traits
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
Measured: Baseline up to 6 weeks and 6 months
Change in Behavioral (depression)
Beck Depression Inventory
Measured: Baseline up to 6 weeks and 6 months
Change in Behavioral (anxiety)
State-trait anxiety inventory
Measured: Baseline up to 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start26 Feb 2018
- Primary completion31 Dec 2018
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Centro Neurolesi Bonino Pulejo, IRCCS National Neurological Institute "C. Mondino" Foundation, IRCCS San Camillo, Venezia, Italy, IRCCS San Raffaele Roma, Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Principal investigator, Francesca Baglio, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444454
- Sponsor's protocol ID
- FdG_VRRS_MS_01
- Status last verified
- May 2024
- First submitted
- 2 Feb 2018
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31132909Pagliari 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.
PubMed 34851211
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System for Continuum of Care in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03444454
- Acronym / sponsor ID
- FdG_VRRS_MS_01
- Conditions
- Multiple Sclerosis
- Keywords
- Telerehabilitation, Virtual reality, Quality of life, transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- IRCCS Centro Neurolesi Bonino Pulejo, IRCCS National Neurological Institute "C. Mondino" Foundation, IRCCS San Camillo, Venezia, Italy, IRCCS San Raffaele Roma, Istituti Clinici Scientifici Maugeri SpA
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VRRS Khymeia | Experimental | Behavioral: VRRS KhymeiaThe 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. |
| Usual care program | Active comparator | Behavioral: Usual care programThe usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment. |
| VRRS Khymeia plus active tDCS | Experimental | Behavioral: VRRS Khymeia plus active tDCSThe 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 |
| VRRS Khymeia plus placebo tDCS | Active comparator | Behavioral: VRRS Khymeia plus placebo tDCSThe 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 |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRRS KhymeiaParticipants 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. | Behavioural | VRRS Khymeia |
| Usual care programThe usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment. | Behavioural | Usual care program |
| VRRS Khymeia plus active tDCSParticipants 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. | Behavioural | VRRS Khymeia plus active tDCS |
| VRRS Khymeia plus placebo tDCSParticipants 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. | Behavioural | VRRS Khymeia plus placebo tDCS |
Primary outcome
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
9 secondary outcomes
Change in balance
Time frame: Baseline up to 6 weeks and 6 months
Change in gait
Time frame: Baseline up to 6 weeks and 6 months
Change gross manual dexterity
Time frame: Baseline up to 6 weeks and 6 months
Change in global cognitive status
Time frame: Baseline up to 6 weeks and 6 months
Change cognitive status
Time frame: Baseline up to 6 weeks and 6 months
Change in fatigue
Time frame: Baseline up to 6 weeks and 6 months
Change in Emotional Traits
Time frame: Baseline up to 6 weeks and 6 months
Change in Behavioral (depression)
Time frame: Baseline up to 6 weeks and 6 months
Change in Behavioral (anxiety)
Time frame: Baseline up to 6 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 31132909Di 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.
- Derived from this study: PubMed 34851211Pagliari 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRRS Khymeia and VRRS Khymeia plus active tDCS in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measure of quality of life (time frame: Baseline up to 6 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444454, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.