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

NCT05870254 | Completed

• 1 other identifier: HEALTHYFIT-UVIGO 1/2023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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. 1.ExeRVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook)
2. 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)

Conditions

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

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (3)

• Safety of the IVR intervention

  immediately after the intervention

• Usability of the IVR intervention

  immediately after the intervention

• Satisfaction and experiences post IVR intervention

  immediately after the intervention

Study Arms (2)

ExeRVIEM Protocol

EXPERIMENTAL

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

Usual Protocol

ACTIVE COMPARATOR

They will carry out the usual protocol of Association

Other: Usual center program

Interventions

ExeRVIEM Program OTHER

Virtual exercise based program

ExeRVIEM Protocol

Usual center program OTHER

Usual center cares

ExeRVIEM Protocol; Usual Protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vigo: lead
• Asociación Viguesa de Esclerosis Múltiple de Pontevedra: collaborator

Study Sites (2)

University of Vigo

Pontevedra, Galicia, 36005, Spain

Location

University of Vigo

Pontevedra, 36005, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 23, 2023
• Study Start: January 29, 2024
• Primary Completion: March 25, 2024
• Study Completion: March 29, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)