Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis: ExeRVIEM III (ExeRVIEM III)

July 28, 2026 updated by: Pablo Campo-Prieto, University of Vigo

Effects of a Physiotherapy Program With High-Intensity Exercise and Immersive Virtual Reality in Multiple Sclerosis: Randomized Controlled Trial

TITLE: Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis: ExeRVIEM III. INTRODUCTION: Multiple sclerosis (MS) is a chronic neuroimmunological and degenerative disease characterized by demyelination within the central nervous system. Its clinical course involves motor impairment, sensory disturbances, cognitive dysfunction, and a progressive decline in functional independence. MS is one of the leading causes of non-traumatic disability in young adults. This highlights the considerable impact of the disease, both in terms of healthcare burden and healthcare expenditure. Within this context, therapeutic exercise has evolved from being considered potentially harmful to being recognized as a safe and effective intervention capable of improving gait, balance, cardiorespiratory fitness, fatigue, and quality of life in people with MS. A model has been proposed for prescribing and progressing exercise at different stages of MS: passive range-of-motion exercises designed for patients with the most severe symptoms, a second stage incorporating active muscle-strengthening exercises, and finally, integrated exercise programs that incorporate strength, endurance, balance, and coordination training. Evidence from systematic reviews and meta-analyses shows that structured exercise (including high-intensity protocols when performed under supervision) is safe and can improve functional outcomes. Our ExeRVIEM III project (Physiotherapy program with High-Intensity Exercise Program and Immersive Virtual Reality in Multiple Sclerosis) represents a novel strategy to facilitate rehabilitation exercise programs using head-mounted virtual reality displays. HYPOTHESIS: The ExeRVIEM III project, based on training physical function in people with MS, is feasible and safe, and could have a potential clinical impact in the motor and cognitive domains, as well as applicability in community settings, such as patient associations. GENERAL OBJECTIVES: 1.1 To design and implement an ExeRVIEM III exercise program/protocol for people with MS. 1.2 To evaluate the safety of the high-intensity virtual reality exercise program. SPECIFIC OBJECTIVES: 2.1 To analyze the possible changes in disability, functional variables, cognitive domains and biomarkers in the short and medium term in people who attend a patient association and carry out the ExeRVIEM III exercise program for people with MS. METHODOLOGY: A randomized controlled trial, double-arm (experimental and control group) study will be conducted at a patient association (Santiago de Compostela, Spain). The intervention will consist of an 6-month supervised virtual rehabilitation program, with two weekly sessions on alternate days, in addition to the standard rehabilitation prescribed by the patient association clinical team (physiotherapy, occupational therapy, and cognitive training sessions). An inmersive virtual reality (IVR) body combat exercise videogame will be used, administered via a virtual reality headset. In accordance with clinical guidelines for IVR, sessions will be intentionally brief (10 minutes) to minimize cybersickness and excessive fatigue. Assessments will be conducted at baseline (week 0) and immediately after the intervention (week 24). Demographic and clinical data will also be collected, including sex, age, comorbidities, disease duration, MS subtype, and pharmacological treatment. Assessments will be conducted at the patient association and in the Neurology Department of the referral hospital. Feasibility, safety, strength parameters, dual-task performance and fatigue levels assessments will be performed at the patient association by physiotherapists, while the remaining assessments will be completed at the hospital by a neurologist specializing in MS. The content of the assessments will be: Patient characteristics that will include data on age, sex, years since diagnosis, MS subtype, and pharmacological treatment. Feasibility: Number of virtual sessions attended by each participant (adherence rate via registration sheet). Rate Perceived Effort using the modified Borg scale, which measures the level of perceived exertion on a scale of 0 to 10 from no effort to maximum effort. Safety: adverse events using the Simulator Sickness Questionnaire (SSQ).Strength parameters using Five times sit to stand test (FTSST) and handgrip test. Functional mobility will be assessed using Timed and Go test (TUG) and with dual task performance using TUG-cog. Level of fatigue using the Fatigue Severity Scale (FSS). Level of disability: using the Expanded Disability Status Scale (EDSS).Gait will be evaluated using the 25Foot Walk Test (25FWT). Manual dexterity will be assessed using 9-Hole Peg Test (9HPT). Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT)Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Pontevedra, Spain
        • Recruiting
        • University of Vigo
        • Contact:
          • Dr. Pablo Campo Prieto, PhD
          • Phone Number: +034 986801750
          • Email: pcampo@uvigo.gal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years of age.
  • Confirmed diagnosis of MS.
  • Stable disease with no relapse in the previous 6 weeks.
  • Patients who will be take follow up by a neurologist at the referral hospital and will be members of the patient association.
  • Ability to perform moderate exercise.
  • Capacity to provide informed consent.

Exclusion Criteria:

  • Comorbidities that hinder the development of the VR program
  • Visual or vestibular impairment that would contraindicate VR use.
  • Recent changes in disease modifying therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ExeRVIEM III Protocol + Standard rehabilitation
Virtual exercise based program + Standard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognition sessions)
Other: Virtual Exercise based program
The intervention will consist of a supervised virtual rehabilitation program delivered over 6 months, with two sessions per week on alternating days. An Immersive Virtual Reality body combat-based exergame executed through a VR headset will be used.
Other: Standard rehabilitation
Standard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognitive training sessions).
Active Comparator: Standard rehabilitation
Standard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognition sessions)
Other: Standard rehabilitation
Standard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognitive training sessions).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Level of disability using the Expanded Disability Status Scale (EDSS)
Time Frame: Baseline
EDSS quantifies Multiple sclerosis (MS) related disability on a scale from 0 (normal neurological exa-mination) to 10 (MS related death). Lower scores indicate less disability and generally, and a change of between 0.5 and 1.0 points on the EDSS scale is considered clinically significant, indicating actual progression or improvement in disability.
Baseline
Level of disability using the Expanded Disability Status Scale (EDSS)
Time Frame: week 24
EDSS quantifies Multiple sclerosis (MS) related disability on a scale from 0 (normal neurological exa-mination) to 10 (MS related death). Lower scores indicate less disability and generally, and a change of between 0.5 and 1.0 points on the EDSS scale is considered clinically significant, indicating actual progression or improvement in disability
week 24
Gait evaluated by 25Foot Walk Test (25FWT)
Time Frame: Baseline
25FWT assesses walking speed over 25 feet; shorter times reflect better gait capacity. The 25FWT is a validated, reliable measure accepted by regulatory consortia, predictive of disability progression, where a change greater than 20% in the time taken to walk 25 feet (7.6 meters) is considered relevant to the patient's daily life, indicating a real improvement or deterioration of their functional capacity, beyond the natural variability of the test.
Baseline
Gait evaluated by 25Foot Walk Test (25FWT)
Time Frame: Week 24
25FWT assesses walking speed over 25 feet; shorter times reflect better gait capacity. The 25FWT is a validated, reliable measure accepted by regulatory consortia, predictive of disability progression, where a change greater than 20% in the time taken to walk 25 feet (7.6 meters) is considered relevant to the patient's daily life, indicating a real improvement or deterioration of their functional capacity, beyond the natural variability of the test.
Week 24
Manual dexterity assessed by 9-Hole Peg Test (9HPT)
Time Frame: Baseline
9HPT (right and left) evaluates fine manual dexterity. Lower times indicate better performance. Reductions of approximately 20% are often considered clinically meaningful, particularly in progressive Multiple sclerosis (MS) phenotypes. Often in clinical studies, a change of 2 seconds or more in the average test execution time is considered clinically relevant, indicating an impairment in manual dexterity and fine motor function
Baseline
Manual dexterity assessed by 9-Hole Peg Test (9HPT)
Time Frame: Week 24
9HPT (right and left) evaluates fine manual dexterity. Lower times indicate better performance. Reductions of approximately 20% are often considered clinically meaningful, particularly in progressive Multiple sclerosis (MS) phenotypes. Often in clinical studies, a change of 2 seconds or more in the average test execution time is considered clinically relevant, indicating an impairment in manual dexterity and fine motor function
Week 24
Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT)
Time Frame: Baseline
SDMT assesses cognitive processing speed; higher scores indicate better performance. The SDMT is highly sensitive to cognitive impairment in Multiple sclerosis (MS) and a variation of 4 to 5 points (or a change of at least 10% from baseline) is generally considered to indicate a real and clinically relevant change in the patient's cognitive performance
Baseline
Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT)
Time Frame: Week 24
SDMT assesses cognitive processing speed; higher scores indicate better performance. The SDMT is highly sensitive to cognitive impairment in Multiple sclerosis (MS) and a variation of 4 to 5 points (or a change of at least 10% from baseline) is generally considered to indicate a real and clinically relevant change in the patient's cognitive performance
Week 24
Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations
Time Frame: Baseline
sNfL expressed in serum (pg/mL) evaluates disease progression. Lower levels suggest reduced neuroaxonal damage and may reflect decreased disease activity. In this study, it was performed using an automated assay for measuring sNfL.
Baseline
Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations
Time Frame: Week 24
sNfL expressed in serum (pg/mL) evaluates disease progression. Lower levels suggest reduced neuroaxonal damage and may reflect decreased disease activity. In this study, it was performed using an automated assay for measuring sNfL.
Week 24
Lower limbs strength evaluated by five times sit to stand test (FTSST)
Time Frame: Baseline
FTSST is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movement (5 repetitions standing up and sitting in a chair). Lower times indicate better performance.
Baseline
Lower limbs strength evaluated by five times sit to stand test (FTSST)
Time Frame: Week 24
FTSST is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements (5 repetitions standing up and sitting in a chair). Lower times indicate better performance
Week 24
Functional mobility evaluated by five timed and go test (TUG)
Time Frame: Baseline
TUG is a standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. Lower times indicate better performance.
Baseline
Functional mobility evaluated by five timed and go test (TUG)
Time Frame: Week 24
TUG is a standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. Lower times indicate better performance.
Week 24
Dual task performance evaluated by five timed and go test- cognitive (TUG-cog)
Time Frame: Baseline
It involves performing the TUG physical test while simultaneously carrying out a mental task (such as counting backwards in increments of three). It is an ideal tool for assessing the ability to multitask in older adults or individuals with neurological impairment. Lower times indicate better performance.
Baseline
Dual task performance evaluated by five timed and go test- cognitive (TUG-cog)
Time Frame: Week 24
It involves performing the TUG physical test while simultaneously carrying out a mental task (such as counting backwards in increments of three). It is an ideal tool for assessing the ability to multitask in older adults or individuals with neurological impairment. Lower times better performance.
Week 24
Upper limbs strength evaluated by handgrip test
Time Frame: Baseline
A handgrip strength test measures the maximum force your hand and forearm muscles can make. It acts as a key indicator for overall body strength and healthy aging. Higher scores indicates better performance.
Baseline
Upper limbs strength evaluated by handgrip test
Time Frame: Week 24
A handgrip strength test measures the maximum force your hand and forearm muscles can make. It acts as a key indicator for overall body strength and healthy aging. Higher scores indicates better performance.
Week 24
Levels of fatigue evaluated with The Fatigue Severity Scale (FSS)
Time Frame: Baseline
The FSS is a questionnaire with 9 questions that measures the extreme fatigue that affects many people with multiple sclerosis. Lower scores in the scale indicate less fatigue.
Baseline
Levels of fatigue evaluated with The Fatigue Severity Scale (FSS)
Time Frame: Week 24
The FSS is a questionnaire with 9 questions that measures the extreme fatigue that affects many people with multiple sclerosis. Lower scores in the scale indicate less fatigue.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Vigo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Complejo Hospitalario Universitario de Santiago
ACEM Asociación Compostelá de Esclerose Múltiple, Párkinson e ELA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pablo Campo-Prieto, PhD, University of Vigo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEALTHYFIT-UVIGO 3/2026

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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