このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Evaluation of Gait and Balance Parameters in Patients With Chronic Vestibulopathy

2026年5月30日 更新者: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.

調査の概要

状態

招待による登録

詳細な説明

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.

研究の種類

観察的

入学 (推定)

58

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Küçükçekmece
      • Istanbul、Küçükçekmece、トルコ(Türkiye)、34295
        • İstanbul Aydın University Medicalpark Florya Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Step Length
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Sümeyye Akçay, Asst. Prof.、Fenerbahce University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年5月14日

QC基準を満たした最初の提出物

2026年5月20日

最初の投稿 (実際)

2026年5月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月2日

QC基準を満たした最後の更新が送信されました

2026年5月30日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IstanbulAydinUni

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する