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

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.

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Exercise; Rehabilitation; Physical Therapy; Virtual Reality Exposure Therapy
• Intervention / Treatment: Other: ExeRVIEM Program; Other: Usual center program

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Pontevedra, Spain, 36005
    • University of Vigo
  • Galicia
    • Pontevedra, Galicia, Spain, 36005
      • University of Vigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Virtual exercise based program; Other: Usual center program; Usual center cares
Active Comparator: Usual Protocol; They will carry out the usual protocol of Association	Other: Usual center program; Usual center cares

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance, gait and risk of falling	TINETTI TEST	pre-intervention
Balance, gait and risk of falling	TINETTI TEST	immediately after the intervention
Balance, gait and risk of falling	TINETTI TEST	4 weeks after the intervention
functional autonomy	TIMED UP GO	pre-intervention
functional autonomy	TIMED UP GO	immediately after the intervention
functional autonomy	TIMED UP GO	4 weeks after the intervention
functional and cognitive autonomy	TIMED UP GO COGNITIVE	pre-intervention
functional and cognitive autonomy	TIMED UP GO COGNITIVE	immediately after the intervention
functional and cognitive autonomy	TIMED UP GO COGNITIVE	4 weeks after the intervention
functional mobility and lower limb strength	Five Times Sit to Stand Test	pre-intervention
functional mobility and lower limb strength	Five Times Sit to Stand Test	immediately after the intervention
functional mobility and lower limb strength	Five Times Sit to Stand Test	4 weeks after the intervention
Reaction Time	SOFTWARE REZZIL	pre-intervention
Reaction Time	SOFTWARE REZZIL	immediately after the intervention
Reaction Time	SOFTWARE REZZIL	4 weeks after the intervention
Fatigue	The Fatigue Severity Scale	pre-intervention
Fatigue	The Fatigue Severity Scale	immediately after the intervention
Fatigue	The Fatigue Severity Scale	4 weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the IVR intervention	Simulator Sickness Questionnaire	immediately after the intervention
Usability of the IVR intervention	System Usability Scale	immediately after the intervention
Satisfaction and experiences post IVR intervention	Game Experience Questionnaire-POST GAME MODULE	immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Vigo
• Collaborators: Asociación Viguesa de Esclerosis Múltiple de Pontevedra

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: HEALTHYFIT-UVIGO 1/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No