Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction
Primary Purpose
Bilateral Vestibular Loss, Vestibular Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vestibular Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Vestibular Loss
Eligibility Criteria
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.
Sites / Locations
- Gönül Ertunç Gülçelik
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bilateral Vestibular Hypofunction
Arm Description
Vestibular Rehabilitation in Bilateral Vestibular Hypofunction
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05676307
First Posted
December 2, 2022
Last Updated
December 22, 2022
Sponsor
Istanbul Gedik University
1. Study Identification
Unique Protocol Identification Number
NCT05676307
Brief Title
Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction
Official Title
ETIOLOGICAL FACTORS AND EFFECT OF VESTIBULAR REHABILITATION ON BILATERAL VESTIBULAR HYPOFUNCTION
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
October 23, 2022 (Actual)
Study Completion Date
November 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Gedik University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Vestibular Loss, Vestibular Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral Vestibular Hypofunction
Arm Type
Experimental
Arm Description
Vestibular Rehabilitation in Bilateral Vestibular Hypofunction
Intervention Type
Behavioral
Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
Cawthorne Cooksey Based Vestibular Rehabilitation Exercises (Oculomotor exercise, Vestibulo-ocular Exercise, posture exercise, balance training, etc)
Primary Outcome Measure Information:
Title
Evaluation of Oculomotor Activity (Saccade Frequency Level)
Description
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.
Time Frame
8 week
Title
Quality of Life Assesment
Description
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.
Time Frame
8 weeks
Title
Static Balance Tests
Description
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.
Time Frame
8 weeks
Title
Evaluation of Oculomotor Activity (Pursuit Frequency Level)
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Gönül Ertunç Gülçelik
City
Kocaeli̇
ZIP/Postal Code
41030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction
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