Multiple SclerosisExeRVIEM IIINCT07738120
Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis: ExeRVIEM III
A study testing Virtual Exercise based program and Standard rehabilitation in people with Multiple Sclerosis and Exercise, run by University of Vigo at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Exercise, Physical Therapy
- What is being tested?
- Virtual Exercise based program and Standard rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 6 Oct 2025to 7 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 referral hospital and will be members of the patient association.
- 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. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Vigo
Pontevedra
Dr. Pablo Campo Prieto, PhD, +034 986801750, pcampo@uvigo.gal
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis, Exercise, Physical Therapy, Virtual Reality Exposure Therapy, Rehabilitation Exercise
- Being tested
- Virtual Exercise based program, Standard rehabilitation
- 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 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.
Standard rehabilitationOther
Standard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognitive training sessions).
| Study group | Role | What they receive |
|---|---|---|
| ExeRVIEM III Protocol + Standard rehabilitation | Experimental | Virtual exercise based program + Standard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognition sessions) Receives: Other: Virtual Exercise based program; Other: Standard rehabilitation |
| Standard rehabilitation | Active comparator | Standard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognition sessions) Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of disability using the Expanded Disability Status Scale (EDSS)
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.
Measured: Baseline
Level of disability using the Expanded Disability Status Scale (EDSS)
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
Measured: week 24
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, 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, 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 24
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 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
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 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
Measured: Week 24
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 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
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 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
Measured: Week 24
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.
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.
Measured: Week 24
Lower limbs strength evaluated by five times sit to stand test (FTSST)
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.
Measured: Baseline
Lower limbs strength evaluated by five times sit to stand test (FTSST)
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
Measured: Week 24
Functional mobility evaluated by five timed and go test (TUG)
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.
Measured: Baseline
Functional mobility evaluated by five timed and go test (TUG)
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.
Measured: Week 24
Dual task performance evaluated by five timed and go test- cognitive (TUG-cog)
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.
Measured: Baseline
Dual task performance evaluated by five timed and go test- cognitive (TUG-cog)
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.
Measured: Week 24
Upper limbs strength evaluated by handgrip test
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.
Measured: Baseline
Upper limbs strength evaluated by handgrip test
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.
Measured: Week 24
Levels of fatigue evaluated with The Fatigue Severity Scale (FSS)
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.
Measured: Baseline
Levels of fatigue evaluated with The Fatigue Severity Scale (FSS)
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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start6 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion7 Aug 2026 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arms: experimental group (EG) and control group (CG)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Santiago, ACEM Asociación Compostelá de Esclerose Múltiple, Párkinson e ELA
- 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
- NCT07738120
- Sponsor's protocol ID
- HEALTHYFIT-UVIGO 3/2026
- Acronym
- ExeRVIEM III
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 31 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physiotherapy Program With High-Intensity Exercise and Immersive Virtual Reality in Multiple Sclerosis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07738120
- Acronym / sponsor ID
- ExeRVIEM III / HEALTHYFIT-UVIGO 3/2026
- Conditions
- Multiple Sclerosis, Exercise, Physical Therapy, Virtual Reality Exposure Therapy, Rehabilitation Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Santiago, ACEM Asociación Compostelá de Esclerose Múltiple, Párkinson e ELA
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 31 Jul 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: 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two arms: experimental group (EG) and control group (CG)
| Arm | Type | Receives |
|---|---|---|
| ExeRVIEM III Protocol + Standard rehabilitation | Experimental | Other: Virtual Exercise based program, Other: Standard rehabilitationVirtual exercise based program + Standard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognition sessions) |
| Standard rehabilitation | Active comparator | Other: Standard rehabilitationStandard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognition sessions) |
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 referral hospital and will be members of the patient association.
- 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 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 | ExeRVIEM III Protocol + Standard rehabilitation |
| Standard rehabilitationStandard rehabilitation provided by the clinical team of the patient association (physiotherapy, occupational therapy and cognitive training sessions). | Other | ExeRVIEM III Protocol + Standard rehabilitation, Standard rehabilitation |
Primary outcome
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.
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
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.
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.
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
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
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
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
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
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 and Standard rehabilitation in people with Multiple Sclerosis and Exercise, 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: looking for participants now, as of the sponsor's last update on 31 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Campo-Prieto, PhD (986801770, pcampo@uvigo.gal), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of disability using the Expanded Disability Status Scale (EDSS) (time frame: Baseline). The study lists 20 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 31 Jul 2026.