Virtual Reality-based Rehabilitation

NCT04280302 | Unknown

• 1 other identifier: VESTHJXXIII
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Unilateral Peripheral Vestibular Deficits

Keywords

vestibular; unilateral vestibular; virtual reality; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 Berg Scale (0-56)

  4 weeks

• Change pre-post treatment in Tinneti Test (1-28)

  4 weeks

• Change pre-post treatment in Simulator Sickness Questionnaire (SSQ) (0-14)

  4 weeks

Study Arms (2)

Virtual reality based therapy

EXPERIMENTAL

Behavioral: Virtual Reality-based Rehabilitation

Conventional Therapy

ACTIVE COMPARATOR

Behavioral: Conventional Therapy

Interventions

Virtual Reality-based Rehabilitation BEHAVIORAL

VR-based eye stabilization exercises and balance exercises

Virtual reality based therapy

Conventional Therapy BEHAVIORAL

Conventional rehabilitation therapy based on eye stabilization exercises and balance exercises

Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Pompeu Fabra: lead

Study Sites (1)

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43005, Spain

RECRUITING

Study Officials

• Sandra Sáez Felipe

  ssaezfelipe@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Sáez Felipe

CONTACT

+34977295800; ssaezfelipe@gmail.com

Rosa M San Segundo

CONTACT

+34977295800; rosamaria.sansegundo@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 21, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

ES (1)