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

NCT ID: NCT05870254

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2024-03-29

Brief 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.

Conditions

Multiple Sclerosis; Physical Therapy; Exercise; Virtual Reality Exposure Therapy; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

ExeRVIEM Protocol

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

Group Type: EXPERIMENTAL

ExeRVIEM Program

Intervention Type: OTHER

Virtual exercise based program

Usual center program

Intervention Type: OTHER

Usual center cares

Usual Protocol

They will carry out the usual protocol of Association

Group Type: ACTIVE_COMPARATOR

Usual center program

Intervention Type: OTHER

Usual center cares

Interventions

ExeRVIEM Program

Virtual exercise based program

Intervention Type: OTHER

Usual center program

Usual center cares

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asociación Viguesa de Esclerosis Múltiple de Pontevedra

UNKNOWN

Sponsor Role: collaborator

University of Vigo

OTHER

Sponsor Role: lead

Responsible Party

Pablo Campo-Prieto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vigo

Pontevedra, Galicia, Spain

University of Vigo

Pontevedra, , Spain

Countries

Spain

Other Identifiers

HEALTHYFIT-UVIGO 1/2023

Identifier Type: -

Identifier Source: org_study_id