Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy

30 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Inscription sur invitation

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

58

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Küçükçekmece
      • Istanbul, Küçükçekmece, Turquie (Türkiye), 34295
        • İstanbul Aydın University Medicalpark Florya Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Step Length
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Sümeyye Akçay, Asst. Prof., Fenerbahce University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

14 mai 2026

Première soumission répondant aux critères de contrôle qualité

20 mai 2026

Première publication (Réel)

28 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • IstanbulAydinUni

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner