- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07611604
Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy
Aperçu de l'étude
Statut
Les conditions
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
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Küçükçekmece
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Istanbul, Küçükçekmece, Turquie (Türkiye), 34295
- İstanbul Aydın University Medicalpark Florya Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
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
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Step Length
Délai: Baseline
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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.
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Baseline
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Step Width
Délai: Baseline
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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.
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Baseline
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Lower Extremity Internal Rotation Angle During Walking
Délai: Baseline
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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.
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Baseline
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Lower Extremity External Rotation Angle During Walking
Délai: Baseline
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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.
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Baseline
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Center of Pressure Amplitude With Eyes Open
Délai: Baseline
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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.
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Baseline
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Center of Pressure Amplitude With Eyes Closed
Délai: Baseline
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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.
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Baseline
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Fear of Falling Score
Délai: Baseline
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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.
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Baseline
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Activities-specific Balance Confidence Score
Délai: Baseline
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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.
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Baseline
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Time Maintaining Balance During Modified Clinical Test of Sensory Interaction on Balance
Délai: Baseline
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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.
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Baseline
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Number of Participants With Abnormal Oculomotor Findings by Videonystagmography
Délai: Baseline
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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.
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Baseline
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Center of Pressure Amplitude During Counting While Walking
Délai: Baseline
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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.
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sümeyye Akçay, Asst. Prof., Fenerbahce University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
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) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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