- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07611604
Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
-
-
Küçükçekmece
-
Istanbul, Küçükçekmece, Türkei (türkiye), 34295
- İstanbul Aydın University Medicalpark Florya Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Step Length
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Sümeyye Akçay, Asst. Prof., Fenerbahçe University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- IstanbulAydinUni
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Vestibuläre Dysfunktion
-
Mohamed Adel AlfekyRekrutierungVestibular-Socket-Therapie | Sofortimplantat in Typ-2-ExtraktionsalveoleÄgypten
-
Venus MedTech (HangZhou) Inc.Noch keine RekrutierungNative Right Ventricle Outflow Tract(RVOT) Dysfunction
-
Alexandria UniversityAbgeschlossenSofortimplantation | Vestibular-Socket-Therapie | Typ II SteckdoseÄgypten
-
University Hospital, Strasbourg, FranceNoch keine RekrutierungBorderline-Persönlichkeitsstörung | SCHIZOPHRENIE 1 (Störung) | Vestibular -SyndromeFrankreich
-
Palacky UniversityRekrutierungTemporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal DisordersTschechien
-
Centre Hospitalier Universitaire de NiceRekrutierungZerebelläre Ataxie | Neuropathie | Vestibular AreflexiaFrankreich
-
Roberta BallardMallinckrodt; ONYAbgeschlossenBronchopulmonale Dysplasie | Atemnotsyndrom der Frühgeborenen (Surfactant Dysfunction)Vereinigte Staaten