Vestibular DysfunctionNCT07611604
Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy
An observational study of Vestibular Dysfunction, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
This observational, cross-sectional, comparative study aims to evaluate gait and balance parameters in adults with chronic vestibulopathy and to compare the findings with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Dysfunction
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adults aged 18 to 65 years, including individuals with chronic vestibulopathy who apply to Istanbul Aydın University Medicalpark Florya Hospital and age- and sex-matched healthy volunteers without vestibular symptoms. Participants will be enrolled by convenience sampling.
Who may be able to join
- For the chronic vestibulopathy group:
- Aged 18 to 65 years
- Having dizziness and/or imbalance complaints for at least 1 year
- Having a clinical diagnosis of unilateral or bilateral chronic vestibular dysfunction
- Volunteering to participate in the study and signing the informed consent form
- Having sufficient cognitive and physical ability to understand and perform the assessment tests
Show all 13Show fewer
- For the healthy control group:
- Aged 18 to 65 years
- Having similar age and sex characteristics to the patient group
- No history of vestibular disease, dizziness, or imbalance
- No known neurological, orthopedic, or serious systemic disease that may affect gait or balance
- Volunteering to participate in the study and signing the informed consent form
- Having sufficient cognitive and physical ability to understand and perform the assessment tests
Who cannot join
- For both groups:
- Uncorrected visual impairment at a level that may affect assessment results
- Presence of neurological, orthopedic, or rheumatologic disease that may affect gait and balance performance
- History of surgery or serious trauma affecting the lower extremity within the last 6 months
- Cognitive, communication-related, or physical impairment that may prevent compliance with assessment tests
- Inability to stand or walk independently without an assistive device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İstanbul Aydın University Medicalpark Florya Hospital
Istanbul, Küçükçekmece, 34295
About this study
This observational, cross-sectional, comparative study aims to evaluate gait and balance parameters in adults with chronic vestibulopathy and to compare the findings with healthy individuals. Participants will include adults aged 18 to 65 years with chronic vestibular dysfunction and age- and sex-matched healthy controls without vestibular symptoms. Balance confidence, fear of falling, vestibular function, postural control, center of pressure measurements, and gait parameters will be assessed using clinical scales, videonystagmography, the modified Clinical Test of Sensory Interaction on Balance, and the Euleria Lab system. The study is expected to provide information about the functional effects of chronic vestibulopathy on gait and balance.
Read the detailed description
Chronic vestibulopathy may affect postural control, gait performance, balance confidence, and daily functioning. Although balance problems are commonly reported in individuals with vestibular dysfunction, the combined evaluation of objective gait and balance parameters together with subjective balance-related outcomes may provide a more comprehensive understanding of the functional consequences of chronic vestibular impairment.
This study is designed as an observational, analytical, cross-sectional, comparative study. The study population will consist of two groups: individuals with chronic vestibulopathy and healthy control participants. The patient group will include adults aged 18 to 65 years who have had dizziness and/or imbalance complaints for at least one year and who have been diagnosed with unilateral or bilateral chronic vestibular dysfunction based on clinical evaluation. The healthy control group will include age- and sex-matched adults without a history of vestibular disease, dizziness, or imbalance.
All participants will undergo face-to-face assessment at Istanbul Aydın University Medicalpark Florya Hospital. Demographic and clinical data including age, sex, height, body weight, body mass index, symptom duration, main complaint, vestibular dysfunction type, comorbidities, and fall history will be recorded. Subjective outcomes will include the Tinetti Falls Efficacy Scale to assess fear of falling and the Activities-specific Balance Confidence Scale to assess balance confidence during daily activities.
Vestibular and balance assessments will include the modified Clinical Test of Sensory Interaction on Balance and videonystagmography-based oculomotor evaluation. Postural control will be assessed using center of pressure measurements during static standing conditions with eyes open and eyes closed. Gait analysis will be performed using the Euleria Lab system during self-selected walking. Spatial and kinematic gait parameters, including step length, step width, and lower extremity internal and external rotation angles, will be recorded.
The primary purpose of the study is to compare gait and balance parameters between individuals with chronic vestibulopathy and healthy controls. Secondary aims include examining subjective balance confidence, fear of falling, vestibular findings, and postural control measures in relation to gait and balance performance.
- Conditions
- Vestibular Dysfunction
- Keywords
- Chronic vestibulopathy, Vestibular dysfunction, Gait analysis, Balance assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Vestibulopathy Group | Adults aged 18 to 65 years with dizziness and/or imbalance complaints for at least one year and a clinical diagnosis of unilateral or bilateral chronic vestibular dysfunction. | |
| Healthy Control Group | Age- and sex-matched healthy adults without a history of vestibular disease, dizziness, or imbalance, and without known neurological, orthopedic, or serious systemic disease that may affect gait or balance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Length
Step length will be assessed during free walking using the Euleria Lab system. The mean step length will be recorded for each participant and reported in centimeters.
Measured: Baseline
Step Width
Step width will be assessed during free walking using the Euleria Lab system. The mean step width will be recorded for each participant and reported in centimeters.
Measured: Baseline
Lower Extremity Internal Rotation Angle During Walking
Lower extremity internal rotation angle will be assessed during free walking using the Euleria Lab system. The mean internal rotation angle will be recorded for each participant and reported in degrees.
Measured: Baseline
Lower Extremity External Rotation Angle During Walking
Lower extremity external rotation angle will be assessed during free walking using the Euleria Lab system. The mean external rotation angle will be recorded for each participant and reported in degrees.
Measured: Baseline
Center of Pressure Amplitude With Eyes Open
Center of pressure amplitude will be measured during quiet standing with eyes open for 30 seconds using the Euleria Lab system. The value will be recorded for each participant and reported in millimeters.
Measured: Baseline
Center of Pressure Amplitude With Eyes Closed
Center of pressure amplitude will be measured during quiet standing with eyes closed for 30 seconds using the Euleria Lab system. The value will be recorded for each participant and reported in millimeters.
Measured: Baseline
Fear of Falling Score
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale. The scale includes 10 items scored as 0 or 1. The total score ranges from 0 to 10 points, with higher scores indicating greater fear of falling.
Measured: Baseline
Activities-specific Balance Confidence Score
Balance confidence will be assessed using the Activities-specific Balance Confidence Scale. The scale includes 16 items scored from 0% to 100%. The total score will be calculated as the mean of the item scores and reported as a percentage, with higher scores indicating greater balance confidence.
Measured: Baseline
Time Maintaining Balance During Modified Clinical Test of Sensory Interaction on Balance
Postural stability will be assessed using the modified Clinical Test of Sensory Interaction on Balance. The time the participant maintains balance under the test condition will be recorded and reported in seconds.
Measured: Baseline
Number of Participants With Abnormal Oculomotor Findings by Videonystagmography
Oculomotor function will be assessed using videonystagmography, including saccades, smooth pursuit, and gaze stability. The number of participants with abnormal oculomotor findings will be recorded and reported as participants.
Measured: Baseline
Center of Pressure Amplitude During Counting While Walking
Center of pressure amplitude will be measured during counting while walking using the Euleria Lab system. The mean center of pressure amplitude will be recorded for each participant and reported in millimeters.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DysfunctionStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Akçay, Fenerbahce University
- Investigators
- Sümeyye Akçay, Asst. Prof., Principal investigator, Fenerbahçe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611604
- Sponsor's protocol ID
- IstanbulAydinUni
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset will contain clinical and functional assessment data collected from a limited sample at a single center, and data sharing was not included in the informed consent process. Aggregated study results may be shared through scientific publications or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy
- ClinicalTrials.gov ID
- NCT07611604
- Acronym / sponsor ID
- IstanbulAydinUni
- Conditions
- Vestibular Dysfunction
- Keywords
- Chronic vestibulopathy, Vestibular dysfunction, Gait analysis, Balance assessment
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 May 2026 (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.
This observational, cross-sectional, comparative study aims to evaluate gait and balance parameters in adults with chronic vestibulopathy and to compare the findings with healthy individuals. Participants will include adults aged 18 to 65 years with chronic vestibular dysfunction and age- and sex-matched healthy controls without vestibular symptoms. Balance confidence, fear of falling, vestibular function, postural control, center of pressure measurements, and gait parameters will be assessed using clinical scales, videonystagmography, the modified Clinical Test of Sensory Interaction on Balance, and the Euleria Lab system. The study is expected to provide information about the functional effects of chronic vestibulopathy on gait and balance.
Detailed description
Chronic vestibulopathy may affect postural control, gait performance, balance confidence, and daily functioning. Although balance problems are commonly reported in individuals with vestibular dysfunction, the combined evaluation of objective gait and balance parameters together with subjective balance-related outcomes may provide a more comprehensive understanding of the functional consequences of chronic vestibular impairment.
This study is designed as an observational, analytical, cross-sectional, comparative study. The study population will consist of two groups: individuals with chronic vestibulopathy and healthy control participants. The patient group will include adults aged 18 to 65 years who have had dizziness and/or imbalance complaints for at least one year and who have been diagnosed with unilateral or bilateral chronic vestibular dysfunction based on clinical evaluation. The healthy control group will include age- and sex-matched adults without a history of vestibular disease, dizziness, or imbalance.
All participants will undergo face-to-face assessment at Istanbul Aydın University Medicalpark Florya Hospital. Demographic and clinical data including age, sex, height, body weight, body mass index, symptom duration, main complaint, vestibular dysfunction type, comorbidities, and fall history will be recorded. Subjective outcomes will include the Tinetti Falls Efficacy Scale to assess fear of falling and the Activities-specific Balance Confidence Scale to assess balance confidence during daily activities.
Vestibular and balance assessments will include the modified Clinical Test of Sensory Interaction on Balance and videonystagmography-based oculomotor evaluation. Postural control will be assessed using center of pressure measurements during static standing conditions with eyes open and eyes closed. Gait analysis will be performed using the Euleria Lab system during self-selected walking. Spatial and kinematic gait parameters, including step length, step width, and lower extremity internal and external rotation angles, will be recorded.
The primary purpose of the study is to compare gait and balance parameters between individuals with chronic vestibulopathy and healthy controls. Secondary aims include examining subjective balance confidence, fear of falling, vestibular findings, and postural control measures in relation to gait and balance performance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Vestibulopathy Group | – | –Adults aged 18 to 65 years with dizziness and/or imbalance complaints for at least one year and a clinical diagnosis of unilateral or bilateral chronic vestibular dysfunction. |
| Healthy Control Group | – | –Age- and sex-matched healthy adults without a history of vestibular disease, dizziness, or imbalance, and without known neurological, orthopedic, or serious systemic disease that may affect gait or balance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 18 to 65 years, including individuals with chronic vestibulopathy who apply to Istanbul Aydın University Medicalpark Florya Hospital and age- and sex-matched healthy volunteers without vestibular symptoms. Participants will be enrolled by convenience sampling.
Key inclusion criteria (13 listed)
- Aged 18 to 65 years
- Having dizziness and/or imbalance complaints for at least 1 year
- Having a clinical diagnosis of unilateral or bilateral chronic vestibular dysfunction
- Volunteering to participate in the study and signing the informed consent form
- Having sufficient cognitive and physical ability to understand and perform the assessment tests
Key exclusion criteria (6 listed)
- Uncorrected visual impairment at a level that may affect assessment results
- Presence of neurological, orthopedic, or rheumatologic disease that may affect gait and balance performance
- History of surgery or serious trauma affecting the lower extremity within the last 6 months
- Cognitive, communication-related, or physical impairment that may prevent compliance with assessment tests
- Inability to stand or walk independently without an assistive device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Step Length
Time frame: Baseline
Step length will be assessed during free walking using the Euleria Lab system. The mean step length will be recorded for each participant and reported in centimeters.
Step Width
Time frame: Baseline
Step width will be assessed during free walking using the Euleria Lab system. The mean step width will be recorded for each participant and reported in centimeters.
Lower Extremity Internal Rotation Angle During Walking
Time frame: Baseline
Lower extremity internal rotation angle will be assessed during free walking using the Euleria Lab system. The mean internal rotation angle will be recorded for each participant and reported in degrees.
Lower Extremity External Rotation Angle During Walking
Time frame: Baseline
Lower extremity external rotation angle will be assessed during free walking using the Euleria Lab system. The mean external rotation angle will be recorded for each participant and reported in degrees.
Center of Pressure Amplitude With Eyes Open
Time frame: Baseline
Center of pressure amplitude will be measured during quiet standing with eyes open for 30 seconds using the Euleria Lab system. The value will be recorded for each participant and reported in millimeters.
Center of Pressure Amplitude With Eyes Closed
Time frame: Baseline
Center of pressure amplitude will be measured during quiet standing with eyes closed for 30 seconds using the Euleria Lab system. The value will be recorded for each participant and reported in millimeters.
Fear of Falling Score
Time frame: Baseline
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale. The scale includes 10 items scored as 0 or 1. The total score ranges from 0 to 10 points, with higher scores indicating greater fear of falling.
Activities-specific Balance Confidence Score
Time frame: Baseline
Balance confidence will be assessed using the Activities-specific Balance Confidence Scale. The scale includes 16 items scored from 0% to 100%. The total score will be calculated as the mean of the item scores and reported as a percentage, with higher scores indicating greater balance confidence.
Time Maintaining Balance During Modified Clinical Test of Sensory Interaction on Balance
Time frame: Baseline
Postural stability will be assessed using the modified Clinical Test of Sensory Interaction on Balance. The time the participant maintains balance under the test condition will be recorded and reported in seconds.
Number of Participants With Abnormal Oculomotor Findings by Videonystagmography
Time frame: Baseline
Oculomotor function will be assessed using videonystagmography, including saccades, smooth pursuit, and gaze stability. The number of participants with abnormal oculomotor findings will be recorded and reported as participants.
Center of Pressure Amplitude During Counting While Walking
Time frame: Baseline
Center of pressure amplitude will be measured during counting while walking using the Euleria Lab system. The mean center of pressure amplitude will be recorded for each participant and reported in millimeters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset will contain clinical and functional assessment data collected from a limited sample at a single center, and data sharing was not included in the informed consent process. Aggregated study results may be shared through scientific publications or presentations.
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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.
Sümeyye Akçay, Asst. Prof. principal investigator
Fenerbahçe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Dysfunction, run by Fenerbahce 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 13 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: enrolling by invitation, as of the sponsor's last update on 2 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Step Length (time frame: Baseline). The study lists 11 primary outcomes in all. 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 2 Jun 2026.