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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05676307
Other study ID # 31207858
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date November 12, 2022

Study information

Verified date December 2022
Source Istanbul Gedik University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the etiological factors that constitute bilateral vestibular hypofunction and to investigate the effect of vestibular rehabilitation in these patients. The Caloric test and Video Head Impulse test were applied to evaluate the vestibular hypofunction picture of the patients who applied to Clinic with complaints of vertigo, dizziness and imbalance. Among these patients with BVH, those with vestibular symptoms, imbalance complaints and limited daily living activities were included in rehabilitation. In order to investigate the effectiveness of rehabilitation, oculomotor functions were evaluated using Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System, balance assessment was done with timed balance tests and quality of life assessment was performed with Dizziness Handicap Inventory.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date November 12, 2022
Est. primary completion date October 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients between 18-70 years of age with bilateral vestibular hypofunction and peripheral vestibulopathy Exclusion Criteria: - Patients with unilateral vestibular hypofunction, cerebellar lesion, and cognitive problems were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Vestibular Rehabilitation
Cawthorne Cooksey Based Vestibular Rehabilitation Exercises (Oculomotor exercise, Vestibulo-ocular Exercise, posture exercise, balance training, etc)

Locations

Country Name City State
Turkey Gönül Ertunç Gülçelik Kocaeli?

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Gedik University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Oculomotor Activity (Saccade Frequency Level) Oculomotor Function Level was evaluated with Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System. The name of this web-based system that supports VOR wient in the evaluation part of the vestibular software.sth oculomotor and optokinetic stimuli is Simulation of Vestibulo-Ocular Reflex Exercises (SVORE). This system includes Assessment and Rehabilitation departments. The maximum saccade frequency levels were determined with the measurements. For the evaluation of saccade eye movement, patient will be asked to focus on the objects on the screen. 8 week
Primary Quality of Life Assesment The level of quality of life was evaluated with Dizziness Handicap inventory.The Dizziness Handicap Inventory (DHI), which evaluates the quality of life in vestibular diseases, was used in the study. This 25-item scale determines the emotional and functional outcomes of patients in vestibular system diseases as well as aggravating factors related to dizziness and impaired balance. 8 weeks
Primary Static Balance Tests To evaluate the static balance of the patients; Length of standing in romberg, semitandem, tandem, standing on one leg, eyes open-closed positions were recorded in seconds with a stopwatch. 8 weeks
Primary Evaluation of Oculomotor Activity (Pursuit Frequency Level) Oculomotor Function Level was evaluated with Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System. The name of this web-based system that supports VOR wient in the evaluation part of the vestibular software.sth oculomotor and optokinetic stimuli is Simulation of Vestibulo-Ocular Reflex Exercises (SVORE). This system includes Assessment and Rehabilitation departments. The maximum pursuit frequency levels were determined with the measurements.For the evaluation of pursuit eye movement, patient will be asked to focus continuely on the objects on the screen. 8 weeks
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