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Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy

Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07611604
Enrollment
58
Registered
2026-05-28
Start date
2026-06-01
Completion date
2026-12-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Dysfunction

Keywords

Chronic vestibulopathy, Vestibular dysfunction, Gait analysis, Balance assessment

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.

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.

Interventions

None listed

Sponsors

Fenerbahce University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Step LengthBaselineStep 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 WidthBaselineStep 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 WalkingBaselineLower 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 WalkingBaselineLower 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 OpenBaselineCenter 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 ClosedBaselineCenter 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 ScoreBaselineFear 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 ScoreBaselineBalance 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 BalanceBaselinePostural 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 VideonystagmographyBaselineOculomotor 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 WalkingBaselineCenter 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORSümeyye Akçay, Asst. Prof.

Fenerbahçe University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026