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Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy

30 maja 2026 zaktualizowane przez: Sümeyye Akçay, Fenerbahce University

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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Dysfunkcja przedsionkowa

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Turcja (Türkiye)
- Küçükçekmece
  - Istanbul, Küçükçekmece, Turcja (Türkiye), 34295
    - İstanbul Aydın University Medicalpark Florya Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Step Length Ramy czasowe: 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.	Baseline
Step Width Ramy czasowe: 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.	Baseline
Lower Extremity Internal Rotation Angle During Walking Ramy czasowe: 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.	Baseline
Lower Extremity External Rotation Angle During Walking Ramy czasowe: 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.	Baseline
Center of Pressure Amplitude With Eyes Open Ramy czasowe: 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.	Baseline
Center of Pressure Amplitude With Eyes Closed Ramy czasowe: 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.	Baseline
Fear of Falling Score Ramy czasowe: 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.	Baseline
Activities-specific Balance Confidence Score Ramy czasowe: 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.	Baseline
Time Maintaining Balance During Modified Clinical Test of Sensory Interaction on Balance Ramy czasowe: 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.	Baseline
Number of Participants With Abnormal Oculomotor Findings by Videonystagmography Ramy czasowe: 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.	Baseline
Center of Pressure Amplitude During Counting While Walking Ramy czasowe: 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.	Baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fenerbahce University

Śledczy

Główny śledczy: Sümeyye Akçay, Asst. Prof., Fenerbahce University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

14 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 maja 2026

Pierwszy wysłany (Rzeczywisty)

28 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

IstanbulAydinUni

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .