Skip to main content
Clinical Trials/NCT04280302
NCT04280302
Unknown
Not Applicable

Realitat Virtual Com a Tractament Coadjuvant en rehabilitació Vestibular

Universitat Pompeu Fabra1 site in 1 country20 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients With Unilateral Peripheral Vestibular Deficits
Sponsor
Universitat Pompeu Fabra
Enrollment
20
Locations
1
Primary Endpoint
Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
March 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul Verschure

PhD

Universitat Pompeu Fabra

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change pre-post treatment in Tinneti Test (1-28)(4 weeks)
  • Change pre-post treatment in Berg Scale (0-56)(4 weeks)
  • Change pre-post treatment in the SF 12 Test (0-100)(4 weeks)
  • Change pre-post treatment in Posturography (Wii+software RombergLab)(4 weeks)
  • Change pre-post treatment in Test up and go (TUG)(4 weeks)
  • Change pre-post treatment in the Barthel Index (0-100)(4 weeks)
  • Change pre-post treatment in Simulator Sickness Questionnaire (SSQ) (0-14)(4 weeks)
  • Change pre-post treatment in the Video-head impulse test (vHIT)(4 weeks)

Study Sites (1)

Loading locations...

Similar Trials