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
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.
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.
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 →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.
Exclusion Criteria:
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
They will carry out the usual protocol of Association
Other: Usual center program
Virtual exercise based program
Usual center cares
Balance, gait and risk of falling
TINETTI TEST
Time frame: pre-intervention
Balance, gait and risk of falling
TINETTI TEST
Time frame: immediately after the intervention
Balance, gait and risk of falling
TINETTI TEST
Time frame: 4 weeks after the intervention
functional autonomy
TIMED UP GO
Time frame: pre-intervention
functional autonomy
TIMED UP GO
Time frame: immediately after the intervention
functional autonomy
TIMED UP GO
Time frame: 4 weeks after the intervention
functional and cognitive autonomy
TIMED UP GO COGNITIVE
Time frame: pre-intervention
functional and cognitive autonomy
TIMED UP GO COGNITIVE
Time frame: immediately after the intervention
functional and cognitive autonomy
TIMED UP GO COGNITIVE
Time frame: 4 weeks after the intervention
functional mobility and lower limb strength
Five Times Sit to Stand Test
Time frame: pre-intervention
functional mobility and lower limb strength
Five Times Sit to Stand Test
Time frame: immediately after the intervention
functional mobility and lower limb strength
Five Times Sit to Stand Test
Time frame: 4 weeks after the intervention
Reaction Time
SOFTWARE REZZIL
Time frame: pre-intervention
Reaction Time
SOFTWARE REZZIL
Time frame: immediately after the intervention
Reaction Time
SOFTWARE REZZIL
Time frame: 4 weeks after the intervention
Fatigue
The Fatigue Severity Scale
Time frame: pre-intervention
Fatigue
The Fatigue Severity Scale
Time frame: immediately after the intervention
Fatigue
The Fatigue Severity Scale
Time frame: 4 weeks after the intervention
Safety of the IVR intervention
Simulator Sickness Questionnaire
Time frame: immediately after the intervention
Usability of the IVR intervention
System Usability Scale
Time frame: immediately after the intervention
Satisfaction and experiences post IVR intervention
Game Experience Questionnaire-POST GAME MODULE
Time frame: immediately after the intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University of Vigo