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Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy

2026년 5월 30일 업데이트: 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.

연구 개요

상태

초대로 등록

정황

전정 기능 장애

상세 설명

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.

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

터키 (Türkiye)
- Küçükçekmece
  - Istanbul, Küçükçekmece, 터키 (Türkiye), 34295
    - İstanbul Aydın University Medicalpark Florya Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Step Length 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fenerbahce University

수사관

수석 연구원: Sümeyye Akçay, Asst. Prof., Fenerbahce University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 14일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 30일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

IstanbulAydinUni

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .