Unilateral Vestibular Dysfunction DiseaseNCT06004505
Effect of Vestibular Rehabilitation on Static Posturography Results
A study testing Vestibular Rehabilitation in people with Unilateral Vestibular Dysfunction Disease, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
Thirty subjects with unilateral vestibular hypofunction diagnosed by videonystagmography (VNG) were voluntarily included in the study. In addition to Static Posturography test, head thrust test, Unterberger test, bucket test, eyes open/closed tandem stance test, eyes open/closed semitandem stance test, Romberg test… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unilateral Vestibular Dysfunction Disease
- What is being tested?
- Vestibular Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2022to 16 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with unilateral vestibular hypofunction by VNG
- Individuals aged 18-65
- Normal otomicroscopic examination
Who cannot join
- Individuals with neurological disorders
- Having physical problems that may interfere with walking
- Central finding as a result of the VNG test
- Pathology in temporal bone MRI
- Having a cognitive impairment that prevents communication
- Have a severe visual impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Güneşli Erdem Hospital
Istanbul, Bağcılar, 34200
About this study
Official title: The Effect of Vestibular Rehabilitation on Static Posturography Results in Individuals With Unilateral Vestibular Hypofunction
Thirty subjects with unilateral vestibular hypofunction diagnosed by videonystagmography (VNG) were voluntarily included in the study. In addition to Static Posturography test, head thrust test, Unterberger test, bucket test, eyes open/closed tandem stance test, eyes open/closed semitandem stance test, Romberg test, one leg standing on foam floor with eyes open/closed and before vestibular rehabilitation treatment In the initial evaluations, the Visual Analogue Scale (VAS) and the Dizziness Disability Inventory (DHI) were applied to assess the severity of standing on one leg with eyes open/closed, dynamic visual acuity, vertigo, and fatigue. As a result of the study, it was concluded that vestibular rehabilitation is beneficial in patients with unilateral vestibular hypofunction and its effectiveness can be monitored with Static Posturography.
Read the detailed description
Patients were re-evaluated after 8 weeks of vestibular rehabilitation and the results were compared. The vestibular rehabilitation program was changed every two weeks. During the eight-week period, the patients performed the exercise program 3 times a day with 10 repetitions of each exercise. According to the evaluation results after the treatment, there was a statistically significant improvement in static posturography, especially in the modified-CTSIB test. There was a statistically significant improvement in dynamic visual acuity, head thrust test, bucket test, standing on one leg on firm and foam ground with eyes open/closed, tandem stance test with eyes closed, and Unterberger test. Statistically significant scores were obtained in VAS and DHI results.
- Being tested
- Vestibular Rehabilitation
- Keywords
- Unilateral vestibular hypofunction, balance, static posturography, vestibular rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular RehabilitationOther
The patients received vestibular rehabilitation treatment in 4 sessions at 15-day intervals and applied the given exercise programs as home exercise in the form of 10 repetitions, 3 times a day. The exercises were performed sitting, standing and walking, respectively. Balance exercises were developed by changing the support area, support surface and arm positions. When they come to each session, the exercise programs are according to the patient's condition; alternating standing and walking forward, backward, tandem and semitandem positions.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation Group | Other | Vestibular rehabilitation program; Gaze consisted of stabilization, adaptation, neck and balance exercises. Receives: Other: Vestibular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Posturography
In this study, balance assessment was performed using Otometrics ICS Balance Platform Version 7.1.331 Static Posturography device. The patients were asked to take off their shoes and stand on the pressure platform, align themselves at the zero point seen on the computer screen, and stand as still as possible with their hands at their sides. Posturography, Modified Clinical Test of Sensory Interaction Balance (mCTSIB), Limits of Stability (LOS) and Balance Training included in the device are the evaluations made in the study.
Measured: 8 weeks
Secondary outcomes (8)
Videonystagmography (VNG)
It captures eye movements related to vestibular dysfunction using a video recorder surrounding the eye. Oculomotor tests are done to determine the ability to move the eye at normal speeds. Abnormal responses indicate central dysfunction. Another component of VNG, caloric test; It is a noninvasive method that allows the evaluation of vestibular function as a result of the creation of current in the endolymph by introducing water or air in the low frequency area directly to the eardrum of both ears.
Measured: 8 weeks
Tandem Posture Test
The patient stretched one foot directly in front of the other for 30 seconds without support and tried to maintain his position without falling. The time was kept with a stopwatch.
Measured: 8 weeks
Semitandem Posture Test
The patient stretched one foot slightly in front of the other for 30 seconds without support and tried to maintain her/his position without falling.
Measured: 8 weeks
Romberg Test
The patient tried to maintain her position without falling for 30 seconds with her feet together, eyes closed, arms crossed over her/his shoulder.
Measured: 8 weeks
One Leg Standing Test
The patient was asked to raise one leg while standing. From the moment he lifted his foot, the time began to be kept. The time was kept for 30 seconds. The time was stopped when the patient lowered their foot before 30 seconds. It was applied to both feet with the eye open and closed. Then it was applied on soft ground with eyes open and closed.
Measured: 8 weeks
Head Thrust Test
This test is a simple bedside test aimed at determining the presence of unilateral canal paresis. It is performed by the examiner grasping the patient's head and turning his head to the right and left in a short, small amplitude, high acceleration. Before the movement, the patient is asked to look fixedly at the examiner's nose. If the vestibular system is intact on both sides, the patient's eyes should be facing the target when head thrust is stopped. If there is a decrease in vestibular function during rapid movements, the corrective saccade movement occurs in the eye and the head thrust test is positive.
Measured: 8 weeks
Unterberger Test
It is an eyes-closed step test for the diagnosis of unilateral vestibular dysfunction. In this study, patients were first asked to count 10 steps with their eyes open to get used to it. Then, he was asked to count 50 steps in place with his hands at his sides and his eyes closed. If the patient turned more than 45 degrees to the right or left, the test was positive (abnormal), and straight progression without turning was considered normal.
Measured: 8 weeks
Dynamic Visual Acuity Test
In this study, the patient was seated in a chair 3 m away from the Snellen visual chart consisting of 10 lines of letters hanging on the wall. First, the patient was asked where he could read in the table. The letters in the table are reduced from top to bottom. The patient's head was started to be turned to the right and left 1-2 times per second. Meanwhile, the patient began to read the letters in front of him from top to bottom. When he told us the line where the clarity deteriorated and he started to see blurry, the test was terminated and recorded.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start21 Jan 2022
- Primary completion5 Jul 2022
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Vestibular Dysfunction DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begum Sultan Akar, Istanbul Gelisim University
- Investigators
- Ebru SEVER, Lecturer, Principal investigator, Department of Physiotherapy & RehabilitationGamze KILIÇ, PHD, Principal investigator, Department of Physiotherapy & RehabilitationKaan Can UYANIK, Lecturer, Principal investigator, Department of Health ManagementCengiz ÇELİKYURT, Assistant Professor/MD, Study director, Clinic of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004505
- Sponsor's protocol ID
- begümmaster
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Rehabilitation on Static Posturography Results in Individuals With Unilateral Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT06004505
- Acronym / sponsor ID
- begümmaster
- Keywords
- Unilateral vestibular hypofunction, balance, static posturography, vestibular rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty subjects with unilateral vestibular hypofunction diagnosed by videonystagmography (VNG) were voluntarily included in the study. In addition to Static Posturography test, head thrust test, Unterberger test, bucket test, eyes open/closed tandem stance test, eyes open/closed semitandem stance test, Romberg test, one leg standing on foam floor with eyes open/closed and before vestibular rehabilitation treatment In the initial evaluations, the Visual Analogue Scale (VAS) and the Dizziness Disability Inventory (DHI) were applied to assess the severity of standing on one leg with eyes open/closed, dynamic visual acuity, vertigo, and fatigue. As a result of the study, it was concluded that vestibular rehabilitation is beneficial in patients with unilateral vestibular hypofunction and its effectiveness can be monitored with Static Posturography.
Detailed description
Patients were re-evaluated after 8 weeks of vestibular rehabilitation and the results were compared. The vestibular rehabilitation program was changed every two weeks. During the eight-week period, the patients performed the exercise program 3 times a day with 10 repetitions of each exercise. According to the evaluation results after the treatment, there was a statistically significant improvement in static posturography, especially in the modified-CTSIB test. There was a statistically significant improvement in dynamic visual acuity, head thrust test, bucket test, standing on one leg on firm and foam ground with eyes open/closed, tandem stance test with eyes closed, and Unterberger test. Statistically significant scores were obtained in VAS and DHI results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation Group | Other | Other: Vestibular RehabilitationVestibular rehabilitation program; Gaze consisted of stabilization, adaptation, neck and balance exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with unilateral vestibular hypofunction by VNG
- Individuals aged 18-65
- Normal otomicroscopic examination
Key exclusion criteria (6 listed)
- Individuals with neurological disorders
- Having physical problems that may interfere with walking
- Central finding as a result of the VNG test
- Pathology in temporal bone MRI
- Having a cognitive impairment that prevents communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular RehabilitationThe patients received vestibular rehabilitation treatment in 4 sessions at 15-day intervals and applied the given exercise programs as home exercise in the form of 10 repetitions, 3 times a day. The exercises were performed sitting, standing and walking, respectively. Balance exercises were developed by changing the support area, support surface and arm positions. When they come to each session, the exercise programs are according to the patient's condition; alternating standing and walking forward, backward, tandem and semitandem positions. | Other | Vestibular Rehabilitation Group |
Primary outcome
Static Posturography
Time frame: 8 weeks
In this study, balance assessment was performed using Otometrics ICS Balance Platform Version 7.1.331 Static Posturography device. The patients were asked to take off their shoes and stand on the pressure platform, align themselves at the zero point seen on the computer screen, and stand as still as possible with their hands at their sides. Posturography, Modified Clinical Test of Sensory Interaction Balance (mCTSIB), Limits of Stability (LOS) and Balance Training included in the device are the evaluations made in the study.
8 secondary outcomes
Videonystagmography (VNG)
Time frame: 8 weeks
Tandem Posture Test
Time frame: 8 weeks
Semitandem Posture Test
Time frame: 8 weeks
Romberg Test
Time frame: 8 weeks
One Leg Standing Test
Time frame: 8 weeks
Head Thrust Test
Time frame: 8 weeks
Unterberger Test
Time frame: 8 weeks
Dynamic Visual Acuity Test
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Unilateral Vestibular Dysfunction Disease
Not yet recruiting
Ai Chi-Based Rehabilitation for Peripheral Unilateral Vestibular Dysfunction
Unilateral Peripheral Vestibular Hypofunction, Vestibular Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru SEVER, Lecturer principal investigator
Department of Physiotherapy & Rehabilitation
Gamze KILIÇ, PHD principal investigator
Department of Physiotherapy & Rehabilitation
Kaan Can UYANIK, Lecturer principal investigator
Department of Health Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation in people with Unilateral Vestibular Dysfunction Disease, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Posturography (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.