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Multiple SclerosisExeRVIEMNCT05870254

Exergaming With Immersive Virtual Reality For People With Multiple Sclerosis (ExeRVIEM)

A study testing ExeRVIEM Program and Usual center program in people with Multiple Sclerosis and Physical Therapy, run by University of Vigo at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TITLE: Exergaming with Immersive Virtual Reality for people with Multiple Sclerosis INTRO: Multiple Sclerosis (MS) is an autoimmune and chronic neurodegenerative pathology caused by loss of the myelin sheath in the nervous system, causing motor, cognitive, behavioral and sensory symptoms. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis, Physical Therapy, Exercise
What is being tested?
ExeRVIEM Program and Usual center program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesSpain
Study dates
29 Jan 2024to 29 Mar 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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • People diagnosed with MS belonging to the AVEMPO VIGO Association
  • Ages between 18-65 years
  • Ability to stay on your feet and follow the intervention protocol and scheduled assessments

Who cannot join

  • Medical report that advises against the practice of physical activity and exercise
  • Uncontrolled outbreak of the disease
  • Dizziness, vertigo or severe visual impairment.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • University of Vigo

    Pontevedra, Galicia, 36005

  • University of Vigo

    Pontevedra, 36005

Other trials in Spain

About this study

Official title: Exergaming With Immersive Virtual Reality to Improve Functional Abilities in People With Multiple Sclerosis

TITLE: Exergaming with Immersive Virtual Reality for people with Multiple Sclerosis

INTRO: Multiple Sclerosis (MS) is an autoimmune and chronic neurodegenerative pathology caused by loss of the myelin sheath in the nervous system, causing motor, cognitive, behavioral and sensory symptoms.

Read more

Conventional physiotherapy often includes exercise therapies, based on repetitive performances that can sometimes be unmotivating for patients. Immersive Virtual Reality could offer programs based on exercise (exergames) that are motivating, as well as appropriate to the therapeutic objectives of the target group. This tool has already been successfully tested in other groups (post stroke, Parkinson's,...) with promising results.

Our ExeRVIEM project (Exergaming with Immersive Virtual Reality in Multiple Sclerosis) represents a new strategy to improve functionality in people with MS, using an exercise program with Virtual Reality glasses.

HYPOTHESIS: The practice of the ExeRVIEM protocol based on physical function training in people with MS contributes to the maintenance and improvement of functional capacities, reducing the number of falls and increasing their personal autonomy.

GENERAL OBJECTIVES:

1.1 Design and implement an ExeRVIEM exercise program/protocol to improve balance in older people

1.2 Analyze the effects of this ExeRVIEM program/protocol, in the short and medium term in people who attend an Association of patients.

1.3 Identify if there is a relationship between the variables that induce frailty and functional dependence and the ExeRVIEM protocol.

SPECIFIC OBJECTIVES:

2.1 Determine and apply the ExeRVIEM protocol to explore differential effects for 6 minutes a day (2 days a week for 8 weeks).

2.1.1 Improving the functional independence and mobility of people by improving balance, reducing the risk of falls and the correct development of activities of daily living.

2.1.2 Gait improvement. 2.1.3 Improved functionality. 2.1.4 Improving grip strength. 2.1.5 Improving reaction times. 2.1.6 Improving the perception of fatigue

2.2 Determine the influence of parameters related to exposure to RVI.

2.2.1 Safety of the virtual reality exhibition 2.2.2 Usability of the virtual reality exhibition 2.2.3 Personal experiences and satisfaction of the virtual reality exhibition

METHODS:

Design: Randomized controlled trial. People diagnosed with MS who attend the AVEMPO VIGO center in Spain on a regular basis will be invited to participate in the study. After they meet the selection criteria, they will be assigned to an experimental group and a control group. Information on the sociodemographic characteristics and a clinical history of the participants will be collected.

Intervention: Two groups (experimental and control). The experimental group will carry out the ExeRVIEM protocol sessions (6 min) focused on the upper and lower limbs. (2 sessions per week for 8 weeks). All sessions will begin with a warm-up focused on stimulating coordination and joint mobilization, so that the body is predisposed both centrally and peripherally to carry out the session and will end with a stretching routine accompanied by breathing calm and controlled cycles. The session will be supervised by the center's physiotherapist or occupational therapist.

The control group will continue with the usual activities proposed by the center team.

Evaluations: 3 evaluations will be carried out: initial, final (at 8 weeks) and follow-up (one month after the end of the program).

The contents of the evaluations will be:

Patient characteristics: "Ad hoc" record sheet that will include data on age, sex, years since diagnosis, MS subtype, and drug treatment.

  1. ExeRVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook)
  2. Balance, gait and risk of falling (Tinetti Test) 3. Functional mobility and lower limb strength (Five times sit to stand test) 4. Functional autonomy (Timed Up and Go Test- simple and cognitive) 5. Fatigue (Fatigue Severity Scale) 6 Handgrip (dynamometer) 7. Reaction time (Rezzil Software)

Hypothesis: Our findings aim to support the use of new health technologies in the field of rehabilitation and medical care for people with MS, achieving a feasible and safe Immersive Virtual Reality exergaming program.

Being tested
ExeRVIEM Program, Usual center program
Medical subject headings
Multiple Sclerosis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExeRVIEM ProgramOther

    Virtual exercise based program

  • Usual center programOther

    Usual center cares

Study groups in NCT05870254
Study groupRoleWhat they receive
ExeRVIEM ProtocolExperimentalThey will carry out the ExeRVIEM program for 8 weeks (2 times a week). Intervention based on exercise therapies with RVI software.
Receives: Other: ExeRVIEM Program; Other: Usual center program
Usual ProtocolActive comparatorThey will carry out the usual protocol of Association
Receives: Other: Usual center program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance, gait and risk of falling

    TINETTI TEST

    Measured: pre-intervention

  2. Balance, gait and risk of falling

    TINETTI TEST

    Measured: immediately after the intervention

  3. Balance, gait and risk of falling

    TINETTI TEST

    Measured: 4 weeks after the intervention

  4. functional autonomy

    TIMED UP GO

    Measured: pre-intervention

  5. functional autonomy

    TIMED UP GO

    Measured: immediately after the intervention

  6. functional autonomy

    TIMED UP GO

    Measured: 4 weeks after the intervention

  7. functional and cognitive autonomy

    TIMED UP GO COGNITIVE

    Measured: pre-intervention

  8. functional and cognitive autonomy

    TIMED UP GO COGNITIVE

    Measured: immediately after the intervention

  9. functional and cognitive autonomy

    TIMED UP GO COGNITIVE

    Measured: 4 weeks after the intervention

  10. functional mobility and lower limb strength

    Five Times Sit to Stand Test

    Measured: pre-intervention

  11. functional mobility and lower limb strength

    Five Times Sit to Stand Test

    Measured: immediately after the intervention

  12. functional mobility and lower limb strength

    Five Times Sit to Stand Test

    Measured: 4 weeks after the intervention

  13. Reaction Time

    SOFTWARE REZZIL

    Measured: pre-intervention

  14. Reaction Time

    SOFTWARE REZZIL

    Measured: immediately after the intervention

  15. Reaction Time

    SOFTWARE REZZIL

    Measured: 4 weeks after the intervention

  16. Fatigue

    The Fatigue Severity Scale

    Measured: pre-intervention

  17. Fatigue

    The Fatigue Severity Scale

    Measured: immediately after the intervention

  18. Fatigue

    The Fatigue Severity Scale

    Measured: 4 weeks after the intervention

Secondary outcomes (3)
  1. Safety of the IVR intervention

    Simulator Sickness Questionnaire

    Measured: immediately after the intervention

  2. Usability of the IVR intervention

    System Usability Scale

    Measured: immediately after the intervention

  3. Satisfaction and experiences post IVR intervention

    Game Experience Questionnaire-POST GAME MODULE

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2023
  2. Study start29 Jan 2024
  3. Primary completion25 Mar 2024
  4. Study completion29 Mar 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05870254
Sponsor's protocol ID
HEALTHYFIT-UVIGO 1/2023
Acronym
ExeRVIEM
Status last verified
Jun 2025
First submitted
22 Mar 2023
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ExeRVIEM Program and Usual center program in people with Multiple Sclerosis and Physical Therapy, run by University of Vigo at 2 sites in Spain.

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 3 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: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Balance, gait and risk of falling (time frame: pre-intervention). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Jun 2025.

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