- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07611604
Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Küçükçekmece
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Istanbul, Küçükçekmece, Turquia (Türkiye), 34295
- İstanbul Aydın University Medicalpark Florya Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Step Length
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sümeyye Akçay, Asst. Prof., Fenerbahce University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- IstanbulAydinUni
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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