- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05676307
Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction
ETIOLOGICAL FACTORS AND EFFECT OF VESTIBULAR REHABILITATION ON BILATERAL VESTIBULAR HYPOFUNCTION
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kocaeli̇, Turkey, 41030
- Gönül Ertunç Gülçelik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bilateral Vestibular Hypofunction
Vestibular Rehabilitation in Bilateral Vestibular Hypofunction
|
Cawthorne Cooksey Based Vestibular Rehabilitation Exercises (Oculomotor exercise, Vestibulo-ocular Exercise, posture exercise, balance training, etc)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Oculomotor Activity (Saccade Frequency Level)
Time Frame: 8 week
|
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
|
Quality of Life Assesment
Time Frame: 8 weeks
|
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
|
Static Balance Tests
Time Frame: 8 weeks
|
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
|
Evaluation of Oculomotor Activity (Pursuit Frequency Level)
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31207858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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