Multiple SclerosisExeRVIEMNCT05870254
Exergaming With Immersive Virtual Reality For People With Multiple Sclerosis (ExeRVIEM)
A study testing ExeRVIEM Program and Usual center program in people with Multiple Sclerosis and Physical Therapy, run by University of Vigo at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Physical Therapy, Exercise
- What is being tested?
- ExeRVIEM Program and Usual center program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesSpain
- Study dates
- 29 Jan 2024to 29 Mar 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical report that advises against the practice of physical activity and exercise
- Uncontrolled outbreak of the disease
- Dizziness, vertigo or severe visual impairment.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Vigo
Pontevedra, Galicia, 36005
University of Vigo
Pontevedra, 36005
About this study
Official title: Exergaming With Immersive Virtual Reality to Improve Functional Abilities in People With Multiple Sclerosis
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.
Read more
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.
- ExeRVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook)
- Balance, gait and risk of falling (Tinetti Test) 3. Functional mobility and lower limb strength (Five times sit to stand test) 4. Functional autonomy (Timed Up and Go Test- simple and cognitive) 5. Fatigue (Fatigue Severity Scale) 6 Handgrip (dynamometer) 7. Reaction time (Rezzil Software)
Hypothesis: Our findings aim to support the use of new health technologies in the field of rehabilitation and medical care for people with MS, achieving a feasible and safe Immersive Virtual Reality exergaming program.
- Conditions
- Multiple Sclerosis, Physical Therapy, Exercise, Virtual Reality Exposure Therapy, Rehabilitation
- Being tested
- ExeRVIEM Program, Usual center 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.
ExeRVIEM ProgramOther
Virtual exercise based program
Usual center programOther
Usual center cares
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ExeRVIEM Program; Other: Usual center program |
| Usual Protocol | Active comparator | They will carry out the usual protocol of Association Receives: Other: Usual center program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance, gait and risk of falling
TINETTI TEST
Measured: pre-intervention
Balance, gait and risk of falling
TINETTI TEST
Measured: immediately after the intervention
Balance, gait and risk of falling
TINETTI TEST
Measured: 4 weeks after the intervention
functional autonomy
TIMED UP GO
Measured: pre-intervention
functional autonomy
TIMED UP GO
Measured: immediately after the intervention
functional autonomy
TIMED UP GO
Measured: 4 weeks after the intervention
functional and cognitive autonomy
TIMED UP GO COGNITIVE
Measured: pre-intervention
functional and cognitive autonomy
TIMED UP GO COGNITIVE
Measured: immediately after the intervention
functional and cognitive autonomy
TIMED UP GO COGNITIVE
Measured: 4 weeks after the intervention
functional mobility and lower limb strength
Five Times Sit to Stand Test
Measured: pre-intervention
functional mobility and lower limb strength
Five Times Sit to Stand Test
Measured: immediately after the intervention
functional mobility and lower limb strength
Five Times Sit to Stand Test
Measured: 4 weeks after the intervention
Reaction Time
SOFTWARE REZZIL
Measured: pre-intervention
Reaction Time
SOFTWARE REZZIL
Measured: immediately after the intervention
Reaction Time
SOFTWARE REZZIL
Measured: 4 weeks after the intervention
Fatigue
The Fatigue Severity Scale
Measured: pre-intervention
Fatigue
The Fatigue Severity Scale
Measured: immediately after the intervention
Fatigue
The Fatigue Severity Scale
Measured: 4 weeks after the intervention
Secondary outcomes (3)
Safety of the IVR intervention
Simulator Sickness Questionnaire
Measured: immediately after the intervention
Usability of the IVR intervention
System Usability Scale
Measured: immediately after the intervention
Satisfaction and experiences post IVR intervention
Game Experience Questionnaire-POST GAME MODULE
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start29 Jan 2024
- Primary completion25 Mar 2024
- Study completion29 Mar 2024
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Viguesa de Esclerosis Múltiple de Pontevedra
- Responsible party
- Principal investigator, Pablo Campo-Prieto, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870254
- Sponsor's protocol ID
- HEALTHYFIT-UVIGO 1/2023
- Acronym
- ExeRVIEM
- Status last verified
- Jun 2025
- First submitted
- 22 Mar 2023
- Last updated
- 26 Jun 2025
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exergaming With Immersive Virtual Reality to Improve Functional Abilities in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05870254
- Acronym / sponsor ID
- ExeRVIEM / HEALTHYFIT-UVIGO 1/2023
- Conditions
- Multiple Sclerosis, Physical Therapy, Exercise, Virtual Reality Exposure Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Asociación Viguesa de Esclerosis Múltiple de Pontevedra
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 23 May 2023 (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: 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.
- ExeRVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook)
- Balance, gait and risk of falling (Tinetti Test) 3. Functional mobility and lower limb strength (Five times sit to stand test) 4. Functional autonomy (Timed Up and Go Test- simple and cognitive) 5. Fatigue (Fatigue Severity Scale) 6 Handgrip (dynamometer) 7. Reaction time (Rezzil Software)
Hypothesis: Our findings aim to support the use of new health technologies in the field of rehabilitation and medical care for people with MS, achieving a feasible and safe Immersive Virtual Reality exergaming program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ExeRVIEM Protocol | Experimental | Other: ExeRVIEM Program, Other: Usual center programThey will carry out the ExeRVIEM program for 8 weeks (2 times a week). Intervention based on exercise therapies with RVI software. |
| Usual Protocol | Active comparator | Other: Usual center programThey will carry out the usual protocol of Association |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Medical report that advises against the practice of physical activity and exercise
- Uncontrolled outbreak of the disease
- Dizziness, vertigo or severe visual impairment.
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 |
|---|---|---|
| ExeRVIEM ProgramVirtual exercise based program | Other | ExeRVIEM Protocol |
| Usual center programUsual center cares | Other | ExeRVIEM Protocol, Usual Protocol |
Primary outcome
Balance, gait and risk of falling
Time frame: pre-intervention
TINETTI TEST
Balance, gait and risk of falling
Time frame: immediately after the intervention
TINETTI TEST
Balance, gait and risk of falling
Time frame: 4 weeks after the intervention
TINETTI TEST
functional autonomy
Time frame: pre-intervention
TIMED UP GO
functional autonomy
Time frame: immediately after the intervention
TIMED UP GO
functional autonomy
Time frame: 4 weeks after the intervention
TIMED UP GO
functional and cognitive autonomy
Time frame: pre-intervention
TIMED UP GO COGNITIVE
functional and cognitive autonomy
Time frame: immediately after the intervention
TIMED UP GO COGNITIVE
functional and cognitive autonomy
Time frame: 4 weeks after the intervention
TIMED UP GO COGNITIVE
functional mobility and lower limb strength
Time frame: pre-intervention
Five Times Sit to Stand Test
functional mobility and lower limb strength
Time frame: immediately after the intervention
Five Times Sit to Stand Test
functional mobility and lower limb strength
Time frame: 4 weeks after the intervention
Five Times Sit to Stand Test
Reaction Time
Time frame: pre-intervention
SOFTWARE REZZIL
Reaction Time
Time frame: immediately after the intervention
SOFTWARE REZZIL
Reaction Time
Time frame: 4 weeks after the intervention
SOFTWARE REZZIL
Fatigue
Time frame: pre-intervention
The Fatigue Severity Scale
Fatigue
Time frame: immediately after the intervention
The Fatigue Severity Scale
Fatigue
Time frame: 4 weeks after the intervention
The Fatigue Severity Scale
3 secondary outcomes
Safety of the IVR intervention
Time frame: immediately after the intervention
Usability of the IVR intervention
Time frame: immediately after the intervention
Satisfaction and experiences post IVR intervention
Time frame: immediately after the intervention
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 26 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExeRVIEM Program and Usual center program in people with Multiple Sclerosis and Physical Therapy, run by University of Vigo at 2 sites 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 3 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Balance, gait and risk of falling (time frame: pre-intervention). The study lists 18 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 26 Jun 2025.