Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Step Length [Срок оценки: Baseline]
• Step Width [Срок оценки: Baseline]
• Lower Extremity Internal Rotation Angle During Walking [Срок оценки: Baseline]
• Lower Extremity External Rotation Angle During Walking [Срок оценки: Baseline]
• Center of Pressure Amplitude With Eyes Open [Срок оценки: Baseline]
• Center of Pressure Amplitude With Eyes Closed [Срок оценки: Baseline]
• Fear of Falling Score [Срок оценки: Baseline]
• Activities-specific Balance Confidence Score [Срок оценки: Baseline]
• Time Maintaining Balance During Modified Clinical Test of Sensory Interaction on Balance [Срок оценки: Baseline]
• Number of Participants With Abnormal Oculomotor Findings by Videonystagmography [Срок оценки: Baseline]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• İstanbul Aydın University Medicalpark Florya Hospital — Istanbul

Идентификаторы

NCT: NCT07611604 · IstanbulAydinUni

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗