Virtual Reality-based Rehabilitation (VRVEST)

February 20, 2020 updated by: Paul Verschure, Universitat Pompeu Fabra

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Tarragona, Spain, 43005
        • Recruiting
        • Hospital Universitari de Tarragona Joan XXIII
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Therapy
Behavioral: Conventional Therapy
Conventional rehabilitation therapy based on eye stabilization exercises and balance exercises
EXPERIMENTAL: Virtual reality based therapy
Behavioral: Virtual Reality-based Rehabilitation
VR-based eye stabilization exercises and balance exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change pre-post treatment in Posturography (Wii+software RombergLab)
Time Frame: 4 weeks
Change within subjects from baseline to the end of week 4
4 weeks
Change pre-post treatment in Test up and go (TUG)
Time Frame: 4 weeks
Change within subjects from baseline to the end of week 4
4 weeks
Change pre-post treatment in Berg Scale (0-56)
Time Frame: 4 weeks
Change within subjects from baseline to the end of week 4
4 weeks
Change pre-post treatment in Tinneti Test (1-28)
Time Frame: 4 weeks
Change within subjects from baseline to the end of week 4
4 weeks
Change pre-post treatment in Simulator Sickness Questionnaire (SSQ) (0-14)
Time Frame: 4 weeks
Change within subjects from baseline to the end of week 4
4 weeks
Change pre-post treatment in the Video-head impulse test (vHIT)
Time Frame: 4 weeks
Change within subjects from baseline to the end of week 4
4 weeks
Change pre-post treatment in the Barthel Index (0-100)
Time Frame: 4 weeks
Change within subjects from baseline to the end of week 4
4 weeks
Change pre-post treatment in the SF 12 Test (0-100)
Time Frame: 4 weeks
Change within subjects from baseline to the end of week 4
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Pompeu Fabra

Investigators

  • Principal Investigator: Sandra Sáez Felipe, ssaezfelipe@gmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (ACTUAL)

February 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VESTHJXXIII

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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