Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy

NCT07611604 | Enrolling By Invitation

• 1 other identifier: IstanbulAydinUni
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vestibular Dysfunction

Keywords

Chronic vestibulopathy; Vestibular dysfunction; Gait analysis; Balance assessment

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

İstanbul Aydın University Medicalpark Florya Hospital

Istanbul, Küçükçekmece, 34295, Turkey (Türkiye)

Location

Study Officials

• Sümeyye Akçay, Asst. Prof.

  Fenerbahçe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)