Relationship Between Degree of Hypofunction and Vestibular Tests in Patients With Vestibular Hypofunction

August 26, 2024 updated by: Ebru Sever, Istanbul Medipol University Hospital

Investigation of the Relationship Between the Degree of Hypofunction and Vestibular Tests in Patients With Vestibular Hypofunction

Patients with complaints of dizziness and balance problems will be included in the study. Inclusion criteria for the study are; being between the ages of 12-85, having a diagnosis of peripheral vestibular hypofunction. Exclusion criteria from the study are; not being able to communicate, having a diagnosis of central vestibulopathy and having mental disorders. Demographic information form, vestibular tests, balance tests will be used in the evaluation. The demographic information form includes demographic information (name, surname, gender, smoking, alcohol use, etc.) and clinical conditions (past illnesses and/or surgeries, medications used, whether there is a history of falls, if any, frequency, whether they are afraid of heights and uncomfortable in the dark, etc.). The patients will be diagnosed with videonystagmography (VNG) after the decision of the ENT physician, and the degree of hypofunction will be recorded. Vestibular and balance tests will be applied to the patients in a clinical setting. At the end of the study, it will be examined whether there is a relationship between the degree of vestibular hypofunction and the vestibular tests applied in the clinic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Güneşli
      • Bağcılar, Güneşli, Turkey, 34200
        • Recruiting
        • Güneşli Erdem Hospital
        • Contact:
          • Güneşli Erdem Hospital
          • Phone Number: 08502220494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between 12-85 years old
  • Having peripheral vestibular hypofunction
  • Having good communication skills and participating in the work willingly

Exclusion Criteria:

  • Having wavy vertigo
  • Having mental retardation
  • Failure to communicate
  • Severely limited mobility
  • Having acute Meniere's disease
  • Having a neurological problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Vestibular Hypofunction Group
Diagnostic test: Vestibular Hypofunction Group
Demographic information form, vestibular tests, balance tests will be used in the evaluation. The demographic information form includes demographic information (name, surname, gender, smoking, alcohol use, etc.) and clinical conditions (past illnesses and/or surgeries, medications used, whether there is a history of falls, if any, frequency, whether they are afraid of heights and uncomfortable in the dark, etc.). The patients will be diagnosed with videonystagmography (VNG) after the decision of the ENT physician, and their hypofunction levels will be recorded. Vestibular and balance tests will be applied to the patients in the clinical setting. At the end of the study, it will be examined whether there is a relationship between the degree of vestibular hypofunction and the vestibular tests applied in the clinic.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographic information and data collection form
Time Frame: through study completion, average 2 months
This form will ask questions about the patient's age, gender, occupation, whether or not they smoke or drink alcohol, accompanying illnesses, previous surgeries, medications they use, daily activity level, history of the disease, onset and type of the disease, whether or not they have fallen in the last year and if so, how many falls, fear of heights, fear of darkness and discomfort with crowds.
through study completion, average 2 months
Unterberger Test
Time Frame: through study completion, average 2 months
It is a test that shows which labyrinth is affected and cannot function in peripheral vestibular diseases. The patient makes a counting movement in place 50 times with his eyes closed. If there is a deviation of 45 degrees or more to the right or left after the counting movement, this gives us information that the labyrinth on that side cannot function.
through study completion, average 2 months
Dynamic Visual Acuity
Time Frame: through study completion, average 2 months
It is the situation where the visual event is realized clearly while moving. The test is started by passively moving the patient's head in the horizontal plane with a 20° amplitude and 2 Hz speed and the patient starts reading the letters on the Snellen card. The line that can be seen clearly is recorded. The dynamic visual acuity score is the difference between the number of lines on the visual graph when the head is moving passively against the stationary head. In healthy individuals, visual acuity may change by one line in young individuals and by two lines in older individuals. In uncompensated patients, the degree of visual acuity may change by three or two lines in unilateral vestibular losses.
through study completion, average 2 months
Head Thrust Test
Time Frame: through study completion, average 2 months
It is a test used to evaluate the function of the vestibulo-ocular reflex (VOR). The head thrust test can be applied in all planes of the semicircular canals. The patient sits on a chair. The physiotherapist or the practitioner stands in front of the patient. The patient is asked to focus on his nose and the patient's head is held and the head is rotated in a horizontal plane with low amplitude and high acceleration. The patient's ability to keep his eyes fixed on the practitioner's nose indicates that there is no problem in the VOR, while corrective saccadic movement indicates that the test is positive.
through study completion, average 2 months
Timed Balance Tests
Time Frame: through study completion, average 2 months
Tandem, semitandem, romberg, tek ayak üzerinde durma testleri uygulanacaktır. Bu testler gözler açık ve kapalı olacak şekilde uygulanacaktır. Tek ayak üzerinde durma testleri yumuşak zemin ve sert zeminde olmak üzere iki farklı zeminde yapılacaktır. Testler (sn) olarak ölçülecektir.
through study completion, average 2 months
Dizziness Handicap Inventory (DHI)
Time Frame: through study completion, average 2 months
It is used to determine the physical, sensory and functional effects of vestibular system pathologies. Questions 1, 4, 8, 11, 13, 17 and 25 measure physical disability; questions 2, 9, 10, 15, 18, 20, 21, 22 and 23 measure emotional disability; questions 3, 5, 6, 7, 12, 14, 16, 19 and 24 measure functional disability. Each question consists of yes (4 points), no (0 points) and sometimes (2) answers. In scoring the subunits of the inventory, 28 points were accepted as the limit to determine physical disability and 36 points as the limit to determine functional and sensory disability. High scores indicate that the patient's dizziness complaint is at an advanced level.
through study completion, average 2 months
Tampa Kinesiophobia Scale (TKS)
Time Frame: through study completion, average 2 months
A 4-point Likert scale (1 = I completely disagree, 4 = I completely agree) is used. It consists of 17 questions. The total score is calculated after reversing items 4, 8, 12 and 16. It gets a total score between 17-68. A high score indicates that kinesiophobia is also high.
through study completion, average 2 months
Static Posture Assessment with ICS
Time Frame: through study completion, average 2 months
The Limit of Stability (LOS) program in the balance device called "Otometrics ICS Balance Platform" evaluates the points that the body reaches to maintain balance, the speed of movement and direct control in 8 directions. These directions are; front, right-front, right, right-back, back, left-back, left, left-front. The LOS test measures the maximum distance that an individual can consciously change their center of gravity and extend their body in a certain direction without losing their balance and without taking a step.
through study completion, average 2 months
Videonystagmography (VNG)
Time Frame: through study completion, average 2 months
It allows the evaluation of eye movements via cameras sensitive to infrared rays. It is a complex test that allows the examination of the inner ear, including many tests. The test includes; saccade, gaze, tracking, optokinetic, positional tests, Dix Hallpike maneuver and bithermal caloric test. Caloric test is known as the gold standard for the diagnosis of vestibular hypofunction. It reveals the degree, location of hypofunction, whether it is central or peripheral. During the caloric test, thermal stimuli are given and the vestibulo-ocular reflex is evaluated and the pathology is found on which side. 8 liters of air with 50 degrees and 24 degrees temperature, respectively, is sent to the eardrum in 60 seconds with 5-minute rest intervals in both ears. Involuntary eye movements are recorded, calculated and graphed for 120-140 seconds. While evaluating the test result; the onset time of nystagmus, its speed and the possibility of suppression with fixation are examined.
through study completion, average 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ebru SEVER, Master's, Physiotherapy and Rehabilitation
  • Study Director: Gamze KILIÇ, Asst. Prof., Physiotherapy and Rehabilitation
  • Study Director: Gönül ERTUNÇ GÜLÇELİK, Asst. Prof., Physiotherapy and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VNG-VESTIBULAR TESTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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