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CompletedNCT05870254ExeRVIEMUpdated Jun 26, 2025

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

An interventional study of ExeRVIEM Program and Usual center program in Multiple Sclerosis, Physical Therapy and Exercise, sponsored by University of Vigo. Completed at 2 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by University of Vigo · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Multiple Sclerosis
  • Physical Therapy
  • Exercise
  • Virtual Reality Exposure Therapy
  • Rehabilitation
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 18 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Vigo is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Medical report that advises against the practice of physical activity and exercise
  • Uncontrolled outbreak of the disease
  • Dizziness, vertigo or severe visual impairment.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    ExeRVIEM Protocol

    They will carry out the ExeRVIEM program for 8 weeks (2 times a week). Intervention based on exercise therapies with RVI software.

    Other: ExeRVIEM Program · Other: Usual center program

  • Active comparator
    Usual Protocol

    They will carry out the usual protocol of Association

    Other: Usual center program

Interventions

  • OtherExeRVIEM Program

    Virtual exercise based program

  • OtherUsual center program

    Usual center cares

06

What researchers measure

Primary outcomes

  1. Balance, gait and risk of falling

    TINETTI TEST

    Time frame: pre-intervention

  2. Balance, gait and risk of falling

    TINETTI TEST

    Time frame: immediately after the intervention

  3. Balance, gait and risk of falling

    TINETTI TEST

    Time frame: 4 weeks after the intervention

  4. functional autonomy

    TIMED UP GO

    Time frame: pre-intervention

  5. functional autonomy

    TIMED UP GO

    Time frame: immediately after the intervention

  6. functional autonomy

    TIMED UP GO

    Time frame: 4 weeks after the intervention

  7. functional and cognitive autonomy

    TIMED UP GO COGNITIVE

    Time frame: pre-intervention

  8. functional and cognitive autonomy

    TIMED UP GO COGNITIVE

    Time frame: immediately after the intervention

  9. functional and cognitive autonomy

    TIMED UP GO COGNITIVE

    Time frame: 4 weeks after the intervention

  10. functional mobility and lower limb strength

    Five Times Sit to Stand Test

    Time frame: pre-intervention

  11. functional mobility and lower limb strength

    Five Times Sit to Stand Test

    Time frame: immediately after the intervention

  12. functional mobility and lower limb strength

    Five Times Sit to Stand Test

    Time frame: 4 weeks after the intervention

  13. Reaction Time

    SOFTWARE REZZIL

    Time frame: pre-intervention

  14. Reaction Time

    SOFTWARE REZZIL

    Time frame: immediately after the intervention

  15. Reaction Time

    SOFTWARE REZZIL

    Time frame: 4 weeks after the intervention

  16. Fatigue

    The Fatigue Severity Scale

    Time frame: pre-intervention

  17. Fatigue

    The Fatigue Severity Scale

    Time frame: immediately after the intervention

  18. Fatigue

    The Fatigue Severity Scale

    Time frame: 4 weeks after the intervention

Secondary outcomes

  1. Safety of the IVR intervention

    Simulator Sickness Questionnaire

    Time frame: immediately after the intervention

  2. Usability of the IVR intervention

    System Usability Scale

    Time frame: immediately after the intervention

  3. Satisfaction and experiences post IVR intervention

    Game Experience Questionnaire-POST GAME MODULE

    Time frame: immediately after the intervention

07

Study locations

2 sites
  • University of Vigo
    Pontevedra, Galicia 36005, Spain
  • University of Vigo
    Pontevedra, 36005, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05870254
Lead sponsor
University of Vigo
Collaborators
Asociación Viguesa de Esclerosis Múltiple de Pontevedra
Responsible party
Pablo Campo-Prieto (Principal Investigator, University of Vigo) — Principal investigator
First posted
May 23, 2023
Start date
Jan 29, 2024
Primary completion
Mar 25, 2024
Completion
Mar 29, 2024
Last update
Jun 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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