Multiple SclerosisExeRVIEM IINCT07543900
Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis
A study testing Virtual exercise based program in people with Multiple Sclerosis and Exercise (EX), run by University of Vigo at 1 site in Spain.
Trial summary
TITLE: Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis INTRODUCTION: Multiple sclerosis (MS) is a chronic neuroimmunological and degenerative disease characterized by demyelination within the central nervous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Exercise (EX), Physical Therapy
- What is being tested?
- Virtual exercise based program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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 referall hospital and will be members of AVEMPO.
- Ability to perform moderate exercise.
- Capacity to provide informed consent.
Who cannot join
- Comorbidities that hinder the development of the VR program
- Visual or vestibular impairment that would contraindicate VR use.
- Recent changes in disease modifying therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of a High-Intensity Exercise Program With Immersive Virtual Reality in Multiple Sclerosis: Exploratory Study
TITLE: Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis
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 (Effects of a Physiotherapy Program With High-Intensity Exercise and Immersive Virtual Reality in Multiple Sclerosis: Randomized Controlled Trial) represents a novel strategy to facilitate rehabilitation exercise programs using head-mounted virtual reality displays.
Read more
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 feasibility and 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/protocol for people with MS.
METHODOLOGY: A randomized controlled trial with two arms (experimental group and control group. The study will be conducted at the ACEM patient association (Santiago de Compostela, Spain). The intervention will consist of an 6-month supervised virtual physiotherapy program, with two weekly sessions on alternate days, in addition to the standard rehabilitation prescribed by the ACEM 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. Physical capacities assessments will be performed at the patient association supervising by physiotherapist, while the remaining assessments will be completed at the hospital by a neurologist specializing in MS (with blinding). The content of the assessments will be:
Patient characteristics: an ad hoc registration form 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 (side effects related to virtual reality exposure) using the Simulator Sickness Questionnaire (SSQ).
Level o disability: using the Expanded Disability Status Scale (EDSS). Gait will be evaluated using the 25Foot Walk Test (25FWT) and Timed Up and Go test Strengh with a hand dynamometer and the Five times to Sit and Stand test (FSST) Manual dexterity will be assessed using by 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
- Conditions
- Multiple Sclerosis, Exercise (EX), Physical Therapy, Virtual Reality Exposure Therapy, Rehabilitation Exercise
- Being tested
- Virtual exercise based program
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual exercise based programOther
The intervention will consist of a supervised virtual rehabilitation program delivered over 8 weeks, with two sessions per week on alternating days, in addition to the standard rehabilitation prescribed by the AVEMPO clinical team (physiotherapy, occupational therapy and cognitive training sessions). An Immersive Virtual Reality boxing-based exergame executed through a VR headset will be used.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: ExeRVIEM II Protocol | Experimental | Virtual exercise based program Receives: Other: Virtual exercise based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events linked to virtual reality exposure assessed by the Simulator Sickness Questionnaire (SSQ).
SSQ assess the IVR exposure by evaluating potential associated symptoms in three broad domains: 1. oculomotor symptoms; 2. disorientation; 3. nausea. Each item is rated on a four-point scale (0 = feel nothing; 1 = a little; 2 = moderately; and 3 = very much) and the total score (maximum of 48 points) is the sum of the scores of the three subscales.
Measured: Week 8
Usability of the virtual tool assessed by System Usability Scale (SUS).
SUS consists of ten questions on a Likert-type scale. Each question is scored from 1 to 5 based on the degree of agreement or disagreement with each statement, where 5 means strongly agree and 1 means strongly disagree. The algorithm resulting from these responses generates a maximum score of 100 points.
Measured: Week 8
Number of virtual sessions attended by each participant
Adherence rate via registration sheet
Measured: up to 8 weeks
Rate perceived effort (RPE) evaluated by the modified Borg scale.
The modified Borg scale and which measures the RPE on a scale of 0-10 from no exertion (0) to the greatest possible exertion (10).
Measured: up to 8 weeks
Secondary outcomes (10)
Level of disability using the Expanded Disability Status Scale (EDSS)
EDSS quantifies 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
Measured: Baseline
Level of disability using the Expanded Disability Status Scale (EDSS)
EDSS quantifies 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
Measured: Week 8
Gait evaluated by 25Foot Walk Test (25FWT)
25FWT assesses walking speed over 25 feet; shorter times reflect better gait capacity. The 25FWT is a validated, reliable measure accepted by regulatory consortia (MSOAC), 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.
Measured: Baseline
Gait evaluated by 25Foot Walk Test (25FWT)
25FWT assesses walking speed over 25 feet; shorter times reflect better gait capacity. The 25FWT is a validated, reliable measure accepted by regulatory consortia (MSOAC), 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.
Measured: Week 8
Manual dexterity assessed by 9-Hole Peg Test (9HPT)
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 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
Measured: Baseline
Manual dexterity assessed by 9-Hole Peg Test (9HPT)
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 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
Measured: Week 8
Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT)
SDMT assesses cognitive processing speed; higher scores indicate better performance. The SDMT is highly sensitive to cognitive impairment in 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
Measured: Baseline
Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT)
SDMT assesses cognitive processing speed; higher scores indicate better performance. The SDMT is highly sensitive to cognitive impairment in 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
Measured: Week 8
Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations
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 (Fujirebio).
Measured: Baseline
Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations
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 (Fujirebio).
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Mar 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Álvaro Cunqueiro, Complejo Hospitalario Universitario de Santiago, Asociación Viguesa de Esclerosis Múltiple de Pontevedra
- Responsible party
- Principal investigator, Pablo Campo-Prieto, University of Vigo
- Investigators
- Pablo Campo Prieto, PhD, Principal investigator, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543900
- Sponsor's protocol ID
- HEALTHYFIT-UVIGO 1/2026
- Acronym
- ExeRVIEM II
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a High-Intensity Exercise Program With Immersive Virtual Reality in Multiple Sclerosis: Exploratory Study
- ClinicalTrials.gov ID
- NCT07543900
- Acronym / sponsor ID
- ExeRVIEM II / HEALTHYFIT-UVIGO 1/2026
- Conditions
- Multiple Sclerosis, Exercise (EX), Physical Therapy, Virtual Reality Exposure Therapy, Rehabilitation Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Hospital Álvaro Cunqueiro, Complejo Hospitalario Universitario de Santiago, Asociación Viguesa de Esclerosis Múltiple de Pontevedra
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TITLE: Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis
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 (Effects of a Physiotherapy Program With High-Intensity Exercise and Immersive Virtual Reality in Multiple Sclerosis: Randomized Controlled Trial) 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 feasibility and 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/protocol for people with MS.
METHODOLOGY: A randomized controlled trial with two arms (experimental group and control group. The study will be conducted at the ACEM patient association (Santiago de Compostela, Spain). The intervention will consist of an 6-month supervised virtual physiotherapy program, with two weekly sessions on alternate days, in addition to the standard rehabilitation prescribed by the ACEM 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. Physical capacities assessments will be performed at the patient association supervising by physiotherapist, while the remaining assessments will be completed at the hospital by a neurologist specializing in MS (with blinding). The content of the assessments will be:
Patient characteristics: an ad hoc registration form 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 (side effects related to virtual reality exposure) using the Simulator Sickness Questionnaire (SSQ).
Level o disability: using the Expanded Disability Status Scale (EDSS). Gait will be evaluated using the 25Foot Walk Test (25FWT) and Timed Up and Go test Strengh with a hand dynamometer and the Five times to Sit and Stand test (FSST) Manual dexterity will be assessed using by 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: ExeRVIEM II Protocol | Experimental | Other: Virtual exercise based programVirtual exercise based program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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 referall hospital and will be members of AVEMPO.
- Ability to perform moderate exercise.
Key exclusion criteria (3 listed)
- Comorbidities that hinder the development of the VR program
- Visual or vestibular impairment that would contraindicate VR use.
- Recent changes in disease modifying therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual exercise based programThe intervention will consist of a supervised virtual rehabilitation program delivered over 8 weeks, with two sessions per week on alternating days, in addition to the standard rehabilitation prescribed by the AVEMPO clinical team (physiotherapy, occupational therapy and cognitive training sessions). An Immersive Virtual Reality boxing-based exergame executed through a VR headset will be used. | Other | Experimental: ExeRVIEM II Protocol |
Primary outcome
Adverse events linked to virtual reality exposure assessed by the Simulator Sickness Questionnaire (SSQ).
Time frame: Week 8
SSQ assess the IVR exposure by evaluating potential associated symptoms in three broad domains: 1. oculomotor symptoms; 2. disorientation; 3. nausea. Each item is rated on a four-point scale (0 = feel nothing; 1 = a little; 2 = moderately; and 3 = very much) and the total score (maximum of 48 points) is the sum of the scores of the three subscales.
Usability of the virtual tool assessed by System Usability Scale (SUS).
Time frame: Week 8
SUS consists of ten questions on a Likert-type scale. Each question is scored from 1 to 5 based on the degree of agreement or disagreement with each statement, where 5 means strongly agree and 1 means strongly disagree. The algorithm resulting from these responses generates a maximum score of 100 points.
Number of virtual sessions attended by each participant
Time frame: up to 8 weeks
Adherence rate via registration sheet
Rate perceived effort (RPE) evaluated by the modified Borg scale.
Time frame: up to 8 weeks
The modified Borg scale and which measures the RPE on a scale of 0-10 from no exertion (0) to the greatest possible exertion (10).
10 secondary outcomes
Level of disability using the Expanded Disability Status Scale (EDSS)
Time frame: Baseline
Level of disability using the Expanded Disability Status Scale (EDSS)
Time frame: Week 8
Gait evaluated by 25Foot Walk Test (25FWT)
Time frame: Baseline
Gait evaluated by 25Foot Walk Test (25FWT)
Time frame: Week 8
Manual dexterity assessed by 9-Hole Peg Test (9HPT)
Time frame: Baseline
Manual dexterity assessed by 9-Hole Peg Test (9HPT)
Time frame: Week 8
Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT)
Time frame: Baseline
Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT)
Time frame: Week 8
Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations
Time frame: Baseline
Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Campo Prieto, PhD principal investigator
University of Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual exercise based program in people with Multiple Sclerosis and Exercise (EX), run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events linked to virtual reality exposure assessed by the Simulator Sickness Questionnaire (SSQ). (time frame: Week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.