Vestibular SyndromeEquiRVNCT03838562
Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes.
A study testing Vestibular rehabilitation with virtual reality and Standard optokinetic stimulator or dynamic visual surround in people with Vestibular Syndrome and Optokinetic Stimulation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Context and justification: Vertigo leads to medical consultation, interruption of daily activities or work stoppage in 80% of cases. Optokinetic stimulation is used in awareness and adaptation exercises. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Syndrome, Optokinetic Stimulation
- What is being tested?
- Vestibular rehabilitation with virtual reality and Standard optokinetic stimulator or dynamic visual surround
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2019to 4 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatology related to a vestibular disorder, eligible for a rehabilitation program Possible standing position
- Informed subject and having signed the informed consent form
- Major subject
- Affiliation to a social security scheme
Who cannot join
- Badly sighted or blind subject (sharpness <1 / 10th)
- Absence of vision of the reliefs
- Strabismus important
- History of epilepsy
- General state strongly altered
- Pregnant subject
- Major protected by law
- Subject deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site
CH Paul Coste Floret/ Pavillon Jeanne d'Arc/ Leroy
Lamalou-les-Bains
About this study
Official title: Non-inferiority of Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes. Randomized Controlled Trial.
Context and justification: Vertigo leads to medical consultation, interruption of daily activities or work stoppage in 80% of cases. Optokinetic stimulation is used in awareness and adaptation exercises. The technology of three-dimensional head-mounted provides a strong immersion allowing optokinetic stimulation but studies interested in virtual reality in the context of balance rehabilitation have not been able to highlight the superiority of this therapy. The investigators therefore propose a non-inferiority trial because of the affordable price and small size of three-dimensional head-mounted.
Objectives : The objective of this study is to evaluate whether a rehabilitation program using virtual reality is as effective as a reference program using Smart Equitest and an optokinetic stimulator to improve the balance of patients with vestibular syndrome after 3 or 4 weeks of rehabilitation.
Read more
The investigators also assess the disability related to vertigo and balance disorders as well as the tolerance of virtual reality Methodology: Prospective, randomized controlled non-inferiority trial, monocentric, 2 parallel arm, with blind assessed after 3 or 4 weeks of follow-up.
The inclusion criteria are the pathologies eligible for a vestibular rehabilitation program and the possible standing position.
The criteria for non-inclusion are visually impaired or blind subjects, lack of relief vision, history of epilepsy, significant strabismus, permanent bilateral vestibular areflexes and Ménière's disease.
The main evaluation criterion is the balance score obtained with eyes closed on an unstable plane during a sensory organization test performed on a dynamic posturology platform, obtained during the final evaluation.
The secondary judgment criteria are:
- The balance scores obtained in the sensory organization test under other conditions.
- The Dizziness Handicap Inventory obtained during the final evaluation and three months after the end of the program.
- The tolerance of virtual reality will be measured weekly by the Simulator Sickness Questionnaire.
Statistics: The number of subjects to be included is 76, the analysis will first be performed per-protocol, the difference in scores between the two groups will be calculated, as well as its 95% confidence interval. If the lower bound of this interval is above the non-inferiority threshold, the same analysis will be performed on the population intending to treat (all randomized patients).
Process: Recruitment and rehabilitation take place at the CH Coste Floret. The duration of inclusions is 27 months, The duration of patient participation in the protocol is 4 months. Patients are cared for 21 or 28 days with two sessions of physiotherapy per day, five days a week, then resolved by telephone 3 months after the rehabilitation Feasibility: CH Coste Floret has the human and material resources necessary to carry out the protocol. The PMSI data show that the department receives about 40 patients per year who are likely to participate in the protocol.
Outcomes / perspectives: In the event of a result validating the non-inferiority of virtual reality, this study could provide further evidence of the value of this type of tool for the rehabilitation of subjects suffering from vestibular disorders. In addition, a medico-economic study would be possible in order to reinforce the advantages of virtual reality helmets.
- Conditions
- Vestibular Syndrome, Optokinetic Stimulation
- Being tested
- Vestibular rehabilitation with virtual reality, Standard optokinetic stimulator or dynamic visual surround
- Keywords
- virtual reality, vestibular, balance, rehabilitation
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitation with virtual realityOther
Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening.
The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises.
Only visual misinformation is distinct in both groups. Optokinetic application with three-dimensional head-mounted is used in the experimental group.
Standard optokinetic stimulator or dynamic visual surroundOther
Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening.
The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises.
Only visual misinformation is distinct in both groups. Standard optokinetic stimulator (stimulopt) or dynamic visual surround (smart equitest) are used in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Arm | Experimental | Not described Receives: Other: Vestibular rehabilitation with virtual reality |
| Control Arm | Active comparator | Not described Receives: Other: Standard optokinetic stimulator or dynamic visual surround |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance score with eyes closed on an unstable plane during a sensory organization test
Realized with the Framiral® multitest equilibre. Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises
Measured: after 3 or 4 weeks of rehabilitation
Secondary outcomes (4)
Others score of the sensory organization test
Realized with the Framiral® multitest equilibre.Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises
Measured: 3 or 4 weeks
The Dizziness Handicap Inventory
Measured: 3 or 4 weeks
The Dizziness Handicap Inventory
Measured: 4 month
The Simulator Sickness Questionnaire
This questionnaire includes the following questions: "Not at all", "A little", "Moderately" and "Severely", each answer is worth 0, 1, 2 or 3 points. The total score is equal to 48, the two scores are calculable "Nausea" on 27 and "Oculomotor" on 21. The higher the score, the more the side effects are important.l 10 minutes
Measured: weekly from week 1 to week 3 or 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start23 Apr 2019
- Primary completion24 Nov 2023
- Study completion4 Mar 2024
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 Vestibular SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838562
- Sponsor's protocol ID
- RECHMPL18_0243
- Other IDs
- 2018-A02247-48
- Acronym
- EquiRV
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Perf G, Thebault G, Duflos C, Herman F, Cauquil-Gleizes S, Laffont I. Can virtual reality replace conventional vestibular rehabilitation tools in multisensory balance exercises for vestibular disorders? A non-inferiority study. J Neuroeng Rehabil. 2025 Apr 19;22(1):86. doi: 10.1186/s12984-025-01623-x.
PubMed 40253374
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority of Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03838562
- Acronym / sponsor ID
- EquiRV / RECHMPL18_0243
- Conditions
- Vestibular Syndrome, Optokinetic Stimulation
- Keywords
- virtual reality, vestibular, balance, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 12 Feb 2019 (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.
Context and justification: Vertigo leads to medical consultation, interruption of daily activities or work stoppage in 80% of cases. Optokinetic stimulation is used in awareness and adaptation exercises. The technology of three-dimensional head-mounted provides a strong immersion allowing optokinetic stimulation but studies interested in virtual reality in the context of balance rehabilitation have not been able to highlight the superiority of this therapy. The investigators therefore propose a non-inferiority trial because of the affordable price and small size of three-dimensional head-mounted.
Objectives : The objective of this study is to evaluate whether a rehabilitation program using virtual reality is as effective as a reference program using Smart Equitest and an optokinetic stimulator to improve the balance of patients with vestibular syndrome after 3 or 4 weeks of rehabilitation.
The investigators also assess the disability related to vertigo and balance disorders as well as the tolerance of virtual reality Methodology: Prospective, randomized controlled non-inferiority trial, monocentric, 2 parallel arm, with blind assessed after 3 or 4 weeks of follow-up.
The inclusion criteria are the pathologies eligible for a vestibular rehabilitation program and the possible standing position.
The criteria for non-inclusion are visually impaired or blind subjects, lack of relief vision, history of epilepsy, significant strabismus, permanent bilateral vestibular areflexes and Ménière's disease.
The main evaluation criterion is the balance score obtained with eyes closed on an unstable plane during a sensory organization test performed on a dynamic posturology platform, obtained during the final evaluation.
The secondary judgment criteria are:
- The balance scores obtained in the sensory organization test under other conditions.
- The Dizziness Handicap Inventory obtained during the final evaluation and three months after the end of the program.
- The tolerance of virtual reality will be measured weekly by the Simulator Sickness Questionnaire.
Statistics: The number of subjects to be included is 76, the analysis will first be performed per-protocol, the difference in scores between the two groups will be calculated, as well as its 95% confidence interval. If the lower bound of this interval is above the non-inferiority threshold, the same analysis will be performed on the population intending to treat (all randomized patients).
Process: Recruitment and rehabilitation take place at the CH Coste Floret. The duration of inclusions is 27 months, The duration of patient participation in the protocol is 4 months. Patients are cared for 21 or 28 days with two sessions of physiotherapy per day, five days a week, then resolved by telephone 3 months after the rehabilitation Feasibility: CH Coste Floret has the human and material resources necessary to carry out the protocol. The PMSI data show that the department receives about 40 patients per year who are likely to participate in the protocol.
Outcomes / perspectives: In the event of a result validating the non-inferiority of virtual reality, this study could provide further evidence of the value of this type of tool for the rehabilitation of subjects suffering from vestibular disorders. In addition, a medico-economic study would be possible in order to reinforce the advantages of virtual reality helmets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Arm | Experimental | Other: Vestibular rehabilitation with virtual reality |
| Control Arm | Active comparator | Other: Standard optokinetic stimulator or dynamic visual surround |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatology related to a vestibular disorder, eligible for a rehabilitation program Possible standing position
- Informed subject and having signed the informed consent form
- Major subject
- Affiliation to a social security scheme
Key exclusion criteria (8 listed)
- Badly sighted or blind subject (sharpness <1 / 10th)
- Absence of vision of the reliefs
- Strabismus important
- History of epilepsy
- General state strongly altered
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 |
|---|---|---|
| Vestibular rehabilitation with virtual realityBoth group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening. The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises. Only visual misinformation is distinct in both groups. Optokinetic application with three-dimensional head-mounted is used in the experimental group. | Other | Virtual Reality Arm |
| Standard optokinetic stimulator or dynamic visual surroundBoth group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening. The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises. Only visual misinformation is distinct in both groups. Standard optokinetic stimulator (stimulopt) or dynamic visual surround (smart equitest) are used in the control group. | Other | Control Arm |
Primary outcome
Balance score with eyes closed on an unstable plane during a sensory organization test
Time frame: after 3 or 4 weeks of rehabilitation
Realized with the Framiral® multitest equilibre. Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises
4 secondary outcomes
Others score of the sensory organization test
Time frame: 3 or 4 weeks
The Dizziness Handicap Inventory
Time frame: 3 or 4 weeks
The Dizziness Handicap Inventory
Time frame: 4 month
The Simulator Sickness Questionnaire
Time frame: weekly from week 1 to week 3 or 4
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 30 Sep 2025.
- Derived from this study: PubMed 40253374Le Perf G, Thebault G, Duflos C, Herman F, Cauquil-Gleizes S, Laffont I. Can virtual reality replace conventional vestibular rehabilitation tools in multisensory balance exercises for vestibular disorders? A non-inferiority study. J Neuroeng Rehabil. 2025 Apr 19;22(1):86. doi: 10.1186/s12984-025-01623-x.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular rehabilitation with virtual reality and Standard optokinetic stimulator or dynamic visual surround in people with Vestibular Syndrome and Optokinetic Stimulation, run by University Hospital, Montpellier at 1 site in France.
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: finished, as of the sponsor's last update on 30 Sep 2025. 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 France. 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 score with eyes closed on an unstable plane during a sensory organization test (time frame: after 3 or 4 weeks of rehabilitation). 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 NCT03838562, 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 30 Sep 2025.