Patients With Unilateral Peripheral Vestibular DeficitsVRVESTNCT04280302
Virtual Reality-based Rehabilitation
A study testing Virtual Reality-based Rehabilitation and Conventional Therapy in people with Patients With Unilateral Peripheral Vestibular Deficits, run by Universitat Pompeu Fabra at 1 site in Spain.
Trial summary
Vertigo / dizziness, imbalance and other symptoms related to vestibular pathology have a life prevalence of 7.4%. Peripheral and unilateral vestibulopathy are among the most common types, and in some patients the symptoms become chronic and disabling, which makes it difficult for them to lead a normal life and has a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Unilateral Peripheral Vestibular Deficits
- What is being tested?
- Virtual Reality-based Rehabilitation and Conventional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 1 Mar 2021
- 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
- Unilateral vestibular deficit
- Vestibular neuritis
- Sudden hearing loss with vestibular involvement
- Labyrinthitis
- Ménière's disease
- Vestibular Shwannoma
Show all 9Show fewer
- Benign paroxysmal positional vertigo
- Vestibular symptoms (vertigo, dizziness, imbalance, gait instability, kinosis and / or oscillopsy) chronic (more than 6 weeks of evolution)
- Over 18 years old
Who cannot join
- Failure to meet some of the inclusion criteria
- Neurological, traumatological, rheumatological, ophthalmological or systemic pathology that may interfere with the balance
- Inability to understand participation in the study
- Non-acceptance to participate in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43005
Rosa Maria San Segundo Mozo, +34977295800, rosamaria.sansegundo@urv.cat
About this study
Official title: Realitat Virtual Com a Tractament Coadjuvant en rehabilitació Vestibular
Vertigo / dizziness, imbalance and other symptoms related to vestibular pathology have a life prevalence of 7.4%. Peripheral and unilateral vestibulopathy are among the most common types, and in some patients the symptoms become chronic and disabling, which makes it difficult for them to lead a normal life and has a significant socio-economic impact. In recent years, the effect of vestibular rehabilitation with virtual reality has been studied and positive results have been obtained when compared with traditional rehabilitation, but despite rehabilitation there is patients who are still chronic, and the reasons for this prognostic variability are still unknown and require further treatment. Virtual reality-based stimulation can play a significant role as an adjunct to conventional vestibular rehabilitation, improving its effectiveness.
- Being tested
- Virtual Reality-based Rehabilitation, Conventional Therapy
- Keywords
- vestibular, unilateral vestibular, virtual reality, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-based RehabilitationBehavioural
VR-based eye stabilization exercises and balance exercises
Conventional TherapyBehavioural
Conventional rehabilitation therapy based on eye stabilization exercises and balance exercises
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality based therapy | Experimental | Not described Receives: Behavioral: Virtual Reality-based Rehabilitation |
| Conventional Therapy | Active comparator | Not described Receives: Behavioral: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Secondary outcomes (8)
Change pre-post treatment in Posturography (Wii+software RombergLab)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Change pre-post treatment in Test up and go (TUG)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Change pre-post treatment in Berg Scale (0-56)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Change pre-post treatment in Tinneti Test (1-28)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Change pre-post treatment in Simulator Sickness Questionnaire (SSQ) (0-14)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Change pre-post treatment in the Video-head impulse test (vHIT)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Change pre-post treatment in the Barthel Index (0-100)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Change pre-post treatment in the SF 12 Test (0-100)
Change within subjects from baseline to the end of week 4
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Unilateral Peripheral Vestibular DeficitsStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Verschure, Universitat Pompeu Fabra
- Investigators
- Sandra Sáez Felipe, Principal investigator, ssaezfelipe@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280302
- Sponsor's protocol ID
- VESTHJXXIII
- Acronym
- VRVEST
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Realitat Virtual Com a Tractament Coadjuvant en rehabilitació Vestibular
- ClinicalTrials.gov ID
- NCT04280302
- Acronym / sponsor ID
- VRVEST / VESTHJXXIII
- Keywords
- vestibular, unilateral vestibular, virtual reality, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 21 Feb 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.
Vertigo / dizziness, imbalance and other symptoms related to vestibular pathology have a life prevalence of 7.4%. Peripheral and unilateral vestibulopathy are among the most common types, and in some patients the symptoms become chronic and disabling, which makes it difficult for them to lead a normal life and has a significant socio-economic impact. In recent years, the effect of vestibular rehabilitation with virtual reality has been studied and positive results have been obtained when compared with traditional rehabilitation, but despite rehabilitation there is patients who are still chronic, and the reasons for this prognostic variability are still unknown and require further treatment. Virtual reality-based stimulation can play a significant role as an adjunct to conventional vestibular rehabilitation, improving its effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality based therapy | Experimental | Behavioral: Virtual Reality-based Rehabilitation |
| Conventional Therapy | Active comparator | Behavioral: Conventional Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Unilateral vestibular deficit
- Vestibular neuritis
- Sudden hearing loss with vestibular involvement
- Labyrinthitis
- Ménière's disease
Key exclusion criteria (4 listed)
- Failure to meet some of the inclusion criteria
- Neurological, traumatological, rheumatological, ophthalmological or systemic pathology that may interfere with the balance
- Inability to understand participation in the study
- Non-acceptance to participate in the study
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 Reality-based RehabilitationVR-based eye stabilization exercises and balance exercises | Behavioural | Virtual reality based therapy |
| Conventional TherapyConventional rehabilitation therapy based on eye stabilization exercises and balance exercises | Behavioural | Conventional Therapy |
Primary outcome
Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100)
Time frame: 4 weeks
Change within subjects from baseline to the end of week 4
8 secondary outcomes
Change pre-post treatment in Posturography (Wii+software RombergLab)
Time frame: 4 weeks
Change pre-post treatment in Test up and go (TUG)
Time frame: 4 weeks
Change pre-post treatment in Berg Scale (0-56)
Time frame: 4 weeks
Change pre-post treatment in Tinneti Test (1-28)
Time frame: 4 weeks
Change pre-post treatment in Simulator Sickness Questionnaire (SSQ) (0-14)
Time frame: 4 weeks
Change pre-post treatment in the Video-head impulse test (vHIT)
Time frame: 4 weeks
Change pre-post treatment in the Barthel Index (0-100)
Time frame: 4 weeks
Change pre-post treatment in the SF 12 Test (0-100)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
Related trials for Patients With Unilateral Peripheral Vestibular Deficits
Recruiting
Mapping of Vestibular Centers Activation Using fMRI in Patients With Vestibular Schwannoma
Vestibular Schwannoma, Unilateral Vestibular Deficit
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.
Sandra Sáez Felipe principal investigator
ssaezfelipe@gmail.com
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 Reality-based Rehabilitation and Conventional Therapy in people with Patients With Unilateral Peripheral Vestibular Deficits, run by Universitat Pompeu Fabra 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 9 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: status not confirmed, as of the sponsor's last update on 21 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Sáez Felipe (+34977295800, ssaezfelipe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100) (time frame: 4 weeks). 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 21 Feb 2020.