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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04280302
Other study ID # VESTHJXXIII
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date March 1, 2021

Study information

Verified date February 2020
Source Universitat Pompeu Fabra
Contact Sandra Sáez Felipe
Phone +34977295800
Email ssaezfelipe@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms

  • Patients With Unilateral Peripheral Vestibular Deficits

Intervention

Behavioral:
Virtual Reality-based Rehabilitation
VR-based eye stabilization exercises and balance exercises
Conventional Therapy
Conventional rehabilitation therapy based on eye stabilization exercises and balance exercises

Locations

Country Name City State
Spain Hospital Universitari de Tarragona Joan XXIII Tarragona

Sponsors (1)

Lead Sponsor Collaborator
Universitat Pompeu Fabra

Country where clinical trial is conducted

Spain, 

Outcome

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