Multiple SclerosisNCT04497025
Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis
A study testing Immersive Virtual-based vestibular rehabilitation and Conventional vestibular rehabilitation protocol in people with Multiple Sclerosis and Vestibular Disease, run by Maria Jesus Casuso-Holgado at 1 site in Spain.
Trial summary
The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Vestibular Disease, Dizziness
- What is being tested?
- Immersive Virtual-based vestibular rehabilitation and Conventional vestibular rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2026to Dec 2029
- 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
- Both male and female subjects from 18-65 years old
- Clinically diagnosed with any type of multiple sclerosis in accordance with the revised McDonald criteria
- With walking ability according to the Expanded Disability Status Scale score (EDSS =6)
- With the objective presence of dizziness symptoms (Dizziness Handicap Inventory = 16)
Who cannot join
- Blurred vision
- Cognitive impairment (Mini Mental State Examination =24)
- Another neurologic disorder contributing to balance impairment
- Relapse within the last 3 months
- Changes in pharmacotherapy within the last 3 months
- History of vestibular rehabilitation within the last 6 months
- Acute cardiovascular of respiratory illness
- Any other contraindication to physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of an Immersive Virtual Reality-based Vestibular Rehabilitation Program for Dizziness, Balance and Fatigue Improvement in People With Multiple Sclerosis: Protocol for a Pilot Randomised Controlled Study
The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). However, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis.
The primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.
- Conditions
- Multiple Sclerosis, Vestibular Disease, Dizziness, Balance Disorders, Fatigue, Quality of Life
- Being tested
- Immersive Virtual-based vestibular rehabilitation, Conventional vestibular rehabilitation protocol
- Medical subject headings
- Multiple Sclerosis, Vestibular Diseases, Dizziness, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual-based vestibular rehabilitationOther
Vestibular rehabilitation based on virtual environment using a head mounted display
Conventional vestibular rehabilitation protocolOther
"Cawthorne-Cooksey" vestibular rehabilitation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Immersive virtual reality-based vestibular training. | Experimental | Subjects in this group will receive the same intervention than the other group of study, but they will wear a 3D head mounted display (Oculus Quest glasses) and will receive real-time gaming feedback in terms of visual and audio output while using the training system.
Participants will receive a total of 20 sessions (3 sessions of 50 minutes per week, 7 weeks). These sessions will be divided in 10 initial sessions (based on the three first blocks of Cawthorne-Cooksey protocol) and 10 advanced sessions in which vestibular exercises are gradually get more complicated by modifiying the following exercise parameters: base of support width, standing on unstable surface, alternatives single leg support, tandem position, increased velocity of head movements, higher head range motion and coordinated movements with arms and trunk.
Same location, tailoring parameters and physical therapist supervision than conventional vestibular training. Receives: Other: Immersive Virtual-based vestibular rehabilitation |
| Conventional vestibular training. | Active comparator | Subjects in the control group will receive a total of 20 sessions of 50 minutes (3 sessions per week, 7 weeks). They will receive traditional "Cawthorne-Cooksey" vestibular rehabilitation exercises. This program improves vestibular compensation through a mechanism of neuroplasticity known as adaptation, habituation and substitution. Just like the virtual reality intervention it will be divided in 10 initial sessions and 10 advanced sessions. For the advanced phase of intervention exercises parameters were the same described for the virtual vestibular rehabilitation intervention.
A physical therapy with at least two years of expertise in vestibular rehabilitation will adjust the difficulty level. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain). Receives: Other: Conventional vestibular rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of virtual reality-based vestibular rehabilitation
Usability of virtual reality device: System Usability Scale (0-100%). Higher Scores means higher usability
Participation rate
Retention rate
Adherence to treatment rate
Measured: 7 weeks of intervention
Safety of virtual reality-based vestibular rehabilitation
Cybersickness: Scores ranging between 10 and 15 mean significant symptoms and above 20 indicates a simulator problem
Falls registry
Adverse events registry
Measured: 7 weeks of intervention
Secondary outcomes (4)
Change from baseline dizziness symptoms at 7 weeks
Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms.
Measured: 7 weeks after intervention
Change from baseline static balance at 7 weeks
Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance.
Measured: 7 weeks after intervention
Change from baseline fatigue at 7 weeks
Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms.
Measured: 7 weeks after intervention
Change from baseline quality of life at 7 weeks
Multiple Sclerosis Quality of Life Scale 54 (0-100 points). Higher values indicate better quality of life.
Measured: 7 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study startJan 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Jesus Casuso-Holgado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Jesus Casuso-Holgado, University of Seville
- Investigators
- Maria Jesus Casuso-Holgado, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497025
- Sponsor's protocol ID
- RVEM2020
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Garcia-Munoz C, Casuso-Holgado MJ, Hernandez-Rodriguez JC, Pinero-Pinto E, Palomo-Carrion R, Cortes-Vega MD. Feasibility and safety of an immersive virtual reality-based vestibular rehabilitation programme in people with multiple sclerosis experiencing vestibular impairment: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Nov 22;11(11):e051478. doi: 10.1136/bmjopen-2021-051478.
PubMed 34810187
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of an Immersive Virtual Reality-based Vestibular Rehabilitation Program for Dizziness, Balance and Fatigue Improvement in People With Multiple Sclerosis: Protocol for a Pilot Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04497025
- Acronym / sponsor ID
- RVEM2020
- Conditions
- Multiple Sclerosis, Vestibular Disease, Dizziness, Balance Disorders, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maria Jesus Casuso-HolgadoUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Aug 2020 (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.
The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). However, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis.
The primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive virtual reality-based vestibular training. | Experimental | Other: Immersive Virtual-based vestibular rehabilitationSubjects in this group will receive the same intervention than the other group of study, but they will wear a 3D head mounted display (Oculus Quest glasses) and will receive real-time gaming feedback in terms of visual and audio output while using the training system. Participants will receive a total of 20 sessions (3 sessions of 50 minutes per week, 7 weeks). These sessions will be divided in 10 initial sessions (based on the three first blocks of Cawthorne-Cooksey protocol) and 10 advanced sessions in which vestibular exercises are gradually get more complicated by modifiying the following exercise parameters: base of support width, standing on unstable surface, alternatives single leg support, tandem position, increased velocity of head movements, higher head range motion and coordinated movements with arms and trunk. Same location, tailoring parameters and physical therapist supervision than conventional vestibular training. |
| Conventional vestibular training. | Active comparator | Other: Conventional vestibular rehabilitation protocolSubjects in the control group will receive a total of 20 sessions of 50 minutes (3 sessions per week, 7 weeks). They will receive traditional "Cawthorne-Cooksey" vestibular rehabilitation exercises. This program improves vestibular compensation through a mechanism of neuroplasticity known as adaptation, habituation and substitution. Just like the virtual reality intervention it will be divided in 10 initial sessions and 10 advanced sessions. For the advanced phase of intervention exercises parameters were the same described for the virtual vestibular rehabilitation intervention. A physical therapy with at least two years of expertise in vestibular rehabilitation will adjust the difficulty level. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both male and female subjects from 18-65 years old
- Clinically diagnosed with any type of multiple sclerosis in accordance with the revised McDonald criteria
- With walking ability according to the Expanded Disability Status Scale score (EDSS =6)
- With the objective presence of dizziness symptoms (Dizziness Handicap Inventory = 16)
Key exclusion criteria (8 listed)
- Blurred vision
- Cognitive impairment (Mini Mental State Examination =24)
- Another neurologic disorder contributing to balance impairment
- Relapse within the last 3 months
- Changes in pharmacotherapy within the last 3 months
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 |
|---|---|---|
| Immersive Virtual-based vestibular rehabilitationVestibular rehabilitation based on virtual environment using a head mounted display | Other | Immersive virtual reality-based vestibular training. |
| Conventional vestibular rehabilitation protocol"Cawthorne-Cooksey" vestibular rehabilitation exercises. | Other | Conventional vestibular training. |
Primary outcome
Feasibility of virtual reality-based vestibular rehabilitation
Time frame: 7 weeks of intervention
Usability of virtual reality device: System Usability Scale (0-100%). Higher Scores means higher usability Participation rate Retention rate Adherence to treatment rate
Safety of virtual reality-based vestibular rehabilitation
Time frame: 7 weeks of intervention
Cybersickness: Scores ranging between 10 and 15 mean significant symptoms and above 20 indicates a simulator problem Falls registry Adverse events registry
4 secondary outcomes
Change from baseline dizziness symptoms at 7 weeks
Time frame: 7 weeks after intervention
Change from baseline static balance at 7 weeks
Time frame: 7 weeks after intervention
Change from baseline fatigue at 7 weeks
Time frame: 7 weeks after intervention
Change from baseline quality of life at 7 weeks
Time frame: 7 weeks after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 34810187Garcia-Munoz C, Casuso-Holgado MJ, Hernandez-Rodriguez JC, Pinero-Pinto E, Palomo-Carrion R, Cortes-Vega MD. Feasibility and safety of an immersive virtual reality-based vestibular rehabilitation programme in people with multiple sclerosis experiencing vestibular impairment: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Nov 22;11(11):e051478. doi: 10.1136/bmjopen-2021-051478.
- Individual participant dataSharing planned: Yes
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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.
Maria Jesus Casuso-Holgado principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual-based vestibular rehabilitation and Conventional vestibular rehabilitation protocol in people with Multiple Sclerosis and Vestibular Disease, run by Maria Jesus Casuso-Holgado 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 6 May 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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of virtual reality-based vestibular rehabilitation (time frame: 7 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04497025, which also lists 1 linked publication.
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 6 May 2026.