- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07611604
Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskelupaikat
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Küçükçekmece
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Istanbul, Küçükçekmece, Turkki (Türkiye), 34295
- İstanbul Aydın University Medicalpark Florya Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Step Length
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Sümeyye Akçay, Asst. Prof., Fenerbahce University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- IstanbulAydinUni
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