Virtual Reality-based Rehabilitation

Not Applicable

• Conditions: Patients With Unilateral Peripheral Vestibular Deficits
• Interventions: Behavioral: Virtual Reality-based Rehabilitation; Behavioral: Conventional Therapy

• Registration Number: NCT04280302
• Lead Sponsor: Universitat Pompeu Fabra

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-20
• Last Update Submitted: 2020-02-20
• Study First Posted: 2020-02-21
• Last Update Posted: 2020-02-21
• Primary Completion: 2021-01-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality based therapy	Virtual Reality-based Rehabilitation	-
Conventional Therapy	Conventional Therapy	-

Primary Outcome Measures

Name	Time	Method
Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100)	4 weeks	Change within subjects from baseline to the end of week 4

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitari de Tarragona Joan XXIII; 🇪🇸 Tarragona, Spain