Vestibular DisorderDizzyVRNCT06350721
Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR
A study testing DizzyVR in people with Vestibular Disorder and Physical Disability, run by Universidad Loyola Andalucia at 1 site in Spain.
Trial summary
The main goals of this pilot study is to assess the feasibility, usability, satisfaction and safety of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. In addition, it aims to collect preliminary data about clinical effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vestibular Disorder, Physical Disability
- What is being tested?
- DizzyVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between the ages of 18 and 75.
- Confirmed diagnosis of central or peripheral vestibulopathy.
- Preserved walking ability.
- Presence of dizziness symptoms as assessed by the Dizziness Handicap Inventory (> 10 points).
Who cannot join
- Severe visual impairments.
- Cognitive impairment (Mini Mental State Examination < 24).
- Existence of comorbidities severely affecting postural control and balance.
- Uncontrolled systemic diseases that contradict physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
The main goals of this pilot study is to assess the feasibility, usability, satisfaction and safety of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. In addition, it aims to collect preliminary data about clinical effectiveness. The main questions it aims to answer are:
- To assess the feasibility, usability and safety of the system DizzyVR for the vestibular rehabilitation in participants with vestibular disorders.
- To detect and record possible adverse events due to the use of DizzyVR.
- To examine the degree of adherence of the participants to the intervention.
- To know the average success rate of the different games in each session.
- To evaluate the average difficulty levels overcome throughout the intervention.
- To know the usability and satisfaction with the system reported by participants and therapists.
- To assess preliminary efficacy data on the impact of this new vestibular rehabilitation system on dizziness, gait speed, balance confidence and gait stability.
Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR.
Read the detailed description
Once the patient is received in the physiotherapy area of the Vertigo Unit, the researchers will proceed to provide the informational sheet and informed consent, as well as verbally explain the project. After the informed consent is signed, the researchers will collect all descriptive variables, as well as the baseline score of the DHI questionnaire (T0). During the course of the research, the researchers will daily record participants' attendance, the overall percentage of correct answers in each session, the occurrence of undesired effects, and the score of the Simulator Sickness Questionnaire (T1). In the final physiotherapy session (T2), each participant will re-evaluate the DHI questionnaire, as well as the perceived usability questionnaire of the system (SUS) and the virtual systems satisfaction evaluation questionnaire (USEQ). Finally, approximately 15 days after the intervention concludes, participants will be scheduled for in-depth individual perceptions about the system through a semi-structured interview (T3). With the same purpose, after the period of using the DizzyVR system, the researchers will interview the physiotherapists who have participated in this study (T4).
Each patient will receive a total of 8 sessions of vestibular rehabilitation with the DizzyVR system. Each session will last for 50 minutes, with a frequency of one session per week. The total duration of the intervention will be 10 weeks, with the initial assessment/T0 taking place in the first week and the final assessment/T2 in the tenth week. Similarly, the total expected participation time for each participant is set at 12 weeks (T3).
- Conditions
- Vestibular Disorder, Physical Disability
- Being tested
- DizzyVR
- Keywords
- Virtual reality, Vestibular, Head Mounted Display, DizzyVR
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DizzyVRDevice
Each patient will receive a total of 8 sessions of vestibular rehabilitation with the DizzyVR system. Each session will last for 50 minutes, with a frequency of one session per week. The total duration of the intervention will be 10 weeks, with the initial assessment/T0 taking place in the first week and the final assessment/T2 in the tenth week. Similarly, the total expected participation time for each participant is set at 12 weeks (T3).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Each patient will receive a total of 8 sessions of vestibular rehabilitation with the DizzyVR system. Each session will last for 50 minutes, with a frequency of one session per week. The total duration of the intervention will be 10 weeks, with the initial assessment/T0 taking place in the first week and the final assessment/T2 in the tenth week. Similarly, the total expected participation time for each participant is set at 12 weeks (T3). Receives: Device: DizzyVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate
percentage of completed sessions
Measured: 10 weeks
Success rate
Mean success rates of the games per session
Measured: 10 weeks
Progression
Levels of the games accomplished during the sessions.
Measured: 10 weeks
System Usability Scale (SUS)
Participants perceived usability of the system.
Measured: 10 weeks
User Satisfaction Evaluation Questionnaire (USEQ)
Acceptability of the prototype device/software
Measured: 10 weeks
Simulator Sickness Questionnaire (SSQ)
Security of the system
Measured: 10 weeks
Register of risk and number of adverse events experimented by the stakeholders
Security of the prototype device
Measured: 10 weeks
Secondary outcomes (4)
Dizziness Handicap Inventory
Dizziness symptoms
Measured: 10 weeks
Timed Up and Go Test (TUG)
Gait speed
Measured: 10 weeks
Activities-specific Balance Confidence Scale (ABC)
Perceived balance confidence
Measured: 10 weeks
Functional Gait Assessment questionnaire (FGA)
Gait stability
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Oct 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Loyola Andalucia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seville, Universitat Politècnica de València, Universidad de Zaragoza
- Responsible party
- Principal investigator, Cristina García-Muñoz, Universidad Loyola Andalucia
- Investigators
- MARIA JESÚS CASUSO-HOLGADO, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350721
- Sponsor's protocol ID
- DizzyVR
- Acronym
- DizzyVR
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of study will be only manage by the researchers of study and the physiotherapist of the clinic
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR
- ClinicalTrials.gov ID
- NCT06350721
- Acronym / sponsor ID
- DizzyVR / DizzyVR
- Conditions
- Vestibular Disorder, Physical Disability
- Keywords
- Virtual reality, Vestibular, Head Mounted Display, DizzyVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad Loyola AndaluciaUniversity, hospital or other
- Collaborators
- University of Seville, Universitat Politècnica de València, Universidad de Zaragoza
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 5 Apr 2024 (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 main goals of this pilot study is to assess the feasibility, usability, satisfaction and safety of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. In addition, it aims to collect preliminary data about clinical effectiveness. The main questions it aims to answer are:
- To assess the feasibility, usability and safety of the system DizzyVR for the vestibular rehabilitation in participants with vestibular disorders.
- To detect and record possible adverse events due to the use of DizzyVR.
- To examine the degree of adherence of the participants to the intervention.
- To know the average success rate of the different games in each session.
- To evaluate the average difficulty levels overcome throughout the intervention.
- To know the usability and satisfaction with the system reported by participants and therapists.
- To assess preliminary efficacy data on the impact of this new vestibular rehabilitation system on dizziness, gait speed, balance confidence and gait stability.
Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR.
Detailed description
Once the patient is received in the physiotherapy area of the Vertigo Unit, the researchers will proceed to provide the informational sheet and informed consent, as well as verbally explain the project. After the informed consent is signed, the researchers will collect all descriptive variables, as well as the baseline score of the DHI questionnaire (T0). During the course of the research, the researchers will daily record participants' attendance, the overall percentage of correct answers in each session, the occurrence of undesired effects, and the score of the Simulator Sickness Questionnaire (T1). In the final physiotherapy session (T2), each participant will re-evaluate the DHI questionnaire, as well as the perceived usability questionnaire of the system (SUS) and the virtual systems satisfaction evaluation questionnaire (USEQ). Finally, approximately 15 days after the intervention concludes, participants will be scheduled for in-depth individual perceptions about the system through a semi-structured interview (T3). With the same purpose, after the period of using the DizzyVR system, the researchers will interview the physiotherapists who have participated in this study (T4).
Each patient will receive a total of 8 sessions of vestibular rehabilitation with the DizzyVR system. Each session will last for 50 minutes, with a frequency of one session per week. The total duration of the intervention will be 10 weeks, with the initial assessment/T0 taking place in the first week and the final assessment/T2 in the tenth week. Similarly, the total expected participation time for each participant is set at 12 weeks (T3).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: DizzyVREach patient will receive a total of 8 sessions of vestibular rehabilitation with the DizzyVR system. Each session will last for 50 minutes, with a frequency of one session per week. The total duration of the intervention will be 10 weeks, with the initial assessment/T0 taking place in the first week and the final assessment/T2 in the tenth week. Similarly, the total expected participation time for each participant is set at 12 weeks (T3). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women between the ages of 18 and 75.
- Confirmed diagnosis of central or peripheral vestibulopathy.
- Preserved walking ability.
- Presence of dizziness symptoms as assessed by the Dizziness Handicap Inventory (> 10 points).
Key exclusion criteria (4 listed)
- Severe visual impairments.
- Cognitive impairment (Mini Mental State Examination < 24).
- Existence of comorbidities severely affecting postural control and balance.
- Uncontrolled systemic diseases that contradict physical activity.
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 |
|---|---|---|
| DizzyVREach patient will receive a total of 8 sessions of vestibular rehabilitation with the DizzyVR system. Each session will last for 50 minutes, with a frequency of one session per week. The total duration of the intervention will be 10 weeks, with the initial assessment/T0 taking place in the first week and the final assessment/T2 in the tenth week. Similarly, the total expected participation time for each participant is set at 12 weeks (T3). | Device | Intervention group |
Primary outcome
Adherence rate
Time frame: 10 weeks
percentage of completed sessions
Success rate
Time frame: 10 weeks
Mean success rates of the games per session
Progression
Time frame: 10 weeks
Levels of the games accomplished during the sessions.
System Usability Scale (SUS)
Time frame: 10 weeks
Participants perceived usability of the system.
User Satisfaction Evaluation Questionnaire (USEQ)
Time frame: 10 weeks
Acceptability of the prototype device/software
Simulator Sickness Questionnaire (SSQ)
Time frame: 10 weeks
Security of the system
Register of risk and number of adverse events experimented by the stakeholders
Time frame: 10 weeks
Security of the prototype device
4 secondary outcomes
Dizziness Handicap Inventory
Time frame: 10 weeks
Timed Up and Go Test (TUG)
Time frame: 10 weeks
Activities-specific Balance Confidence Scale (ABC)
Time frame: 10 weeks
Functional Gait Assessment questionnaire (FGA)
Time frame: 10 weeks
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 25 Sep 2025.
- Individual participant dataSharing planned: No. Data of study will be only manage by the researchers of study and the physiotherapist of the clinic
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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 JESÚS CASUSO-HOLGADO, PhD 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 DizzyVR in people with Vestibular Disorder and Physical Disability, run by Universidad Loyola Andalucia 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 4 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 25 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 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?
Adherence rate (time frame: 10 weeks). The study lists 7 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 25 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.