Virtual Reality-based Rehabilitation (VRVEST)

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: Patients With Unilateral Peripheral Vestibular Deficits
• Intervention / Treatment: Behavioral: Virtual Reality-based Rehabilitation; Behavioral: Conventional Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona, Spain, 43005
    • Recruiting
    • Hospital Universitari de Tarragona Joan XXIII
    • Contact: Rosa Maria San Segundo Mozo; Phone Number: +34977295800; Email: rosamaria.sansegundo@urv.cat

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Universitat Pompeu Fabra
• Investigators: Principal Investigator: Sandra Sáez Felipe, ssaezfelipe@gmail.com

Study record dates

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: rehabilitation; vestibular; virtual reality; unilateral vestibular
• 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