Clinical trial NCT04280302: Virtual Reality-based Rehabilitation
Official title: Realitat Virtual Com a Tractament Coadjuvant en rehabilitació Vestibular
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Unilateral Peripheral Vestibular Deficits
Keywords: vestibular
unilateral vestibular
virtual reality
rehabilitation
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Unilateral vestibular deficit
* Vestibular neuritis
* Sudden hearing loss with vestibular involvement
* Labyrinthitis
* Ménière's disease
* Vestibular Shwannoma
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change pre-post treatment in Posturography (Wii+software RombergLab)
timeFrame: 4 weeks
measure: Change pre-post treatment in Test up and go (TUG)
timeFrame: 4 weeks
measure: Change pre-post treatment in Berg Scale (0-56)
timeFrame: 4 weeks
measure: Change pre-post treatment in Tinneti Test (1-28)
timeFrame: 4 weeks
measure: Change pre-post treatment in Simulator Sickness Questionnaire (SSQ) (0-14)
timeFrame: 4 weeks
measure: Change pre-post treatment in the Video-head impulse test (vHIT)
timeFrame: 4 weeks
measure: Change pre-post treatment in the Barthel Index (0-100)
timeFrame: 4 weeks
measure: Change pre-post treatment in the SF 12 Test (0-100)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
Study officials:
affiliation: ssaezfelipe@gmail.com
name: Sandra Sáez Felipe
role: PRINCIPAL_INVESTIGATOR
References: