- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07559162
Ai Chi-Based Rehabilitation for Peripheral Unilateral Vestibular Dysfunction (AICHI-VR)
Contribution of an Ai Chi-Based Rehabilitation Program in Patients With Peripheral Unilateral Vestibular Dysfunction: A Randomized Prospective Single-Blind Study
Обзор исследования
Статус
Условия
Подробное описание
Unilateral peripheral vestibular hypofunction is a clinical condition characterized by reduced vestibular function due to inner ear or vestibular nerve pathology. It presents with symptoms such as dizziness, imbalance, visual instability, and impaired postural control, significantly affecting functional independence and quality of life. Diagnosis is typically established by the otorhinolaryngology clinic and supported by vestibular function tests such as videonystagmography (VNG) and video head impulse testing (vHIT).
Vestibular rehabilitation is an evidence-based therapeutic approach aimed at promoting central compensation through mechanisms of adaptation, substitution, and habituation. These mechanisms contribute to the improvement of vestibulo-ocular reflex function, postural stability, and overall functional performance.
Ai Chi is an aquatic exercise program derived from Tai Chi and Qi Gong principles, consisting of slow, continuous, and controlled movements coordinated with breathing. The aquatic environment provides unique therapeutic properties such as buoyancy, hydrostatic pressure, and viscosity, allowing safe movement, reducing fall risk, and enhancing proprioceptive and sensory input. These features may support multisensory integration and facilitate central compensation in patients with vestibular dysfunction.
Although aquatic therapy has been increasingly used in rehabilitation, there is limited evidence regarding the effectiveness of Ai Chi specifically in patients with unilateral peripheral vestibular hypofunction. To the best of our knowledge, no randomized controlled study has specifically evaluated the effects of Ai Chi in this patient population.
In this randomized controlled study, participants will be allocated into two groups. Both groups will receive a standardized home-based vestibular rehabilitation program. In addition, the intervention group will participate in supervised Ai Chi sessions conducted in an aquatic environment over a 4-week period, consisting of a total of 10 sessions. All sessions will be delivered by a certified therapist, and adherence will be monitored using exercise logs.
Assessments will be performed at baseline, immediately after the intervention, and during the follow-up period by a blinded evaluator. The findings of this study are expected to contribute to the development of alternative rehabilitation strategies and provide additional evidence for the management of patients with vestibular disorders.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Yaren Çelik
- Номер телефона: +90-507-272-7674
- Электронная почта: celikyaren9797@gmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age between 18 and 70 years
- Diagnosis of unilateral peripheral vestibular hypofunction
- Presence of dizziness symptoms for at least 3 months
- Ability to participate in Ai Chi and aquatic exercise program
- Berg Balance Scale score ≥21
- Willingness to participate in the study
Exclusion Criteria:
- Inability to complete assessment tests and questionnaires
- Severe systemic disease that may interfere with exercise participation
- Central vestibular disorders
- Berg Balance Scale score ≤20
- Severe visual or hearing impairment
- Initiation or change of psychiatric medication within the last 3 weeks
- Severe cardiopulmonary disease
- Contraindications to hydrotherapy, including water phobia, behavioral disorders, dyspnea at rest, incontinence, known chlorine allergy, open wounds, acute systemic illness, epilepsy, tracheostomy, permanent drainage devices, immunodeficiency, or known neurological disorders
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Ai Chi Group
Participants in this group will receive an Ai Chi-based aquatic exercise program in addition to standard home-based vestibular rehabilitation exercises.
The Ai Chi program will be applied over 4 weeks with a total of 10 sessions under the supervision of a certified therapist.
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Ai Chi-based exercise program is a structured aquatic therapy approach consisting of slow, continuous, and controlled movements combined with breathing techniques.
The program will be conducted in a pool environment over 4 weeks, with a total of 10 sessions delivered as group sessions under the supervision of a certified therapist.
The exercises are designed to enhance balance, postural control, proprioceptive input, and multisensory integration, thereby supporting central compensation in patients with vestibular dysfunction.
Participants will receive a structured home-based vestibular rehabilitation program including gaze stabilization, head movement, balance, and postural control exercises.
The program aims to promote vestibulo-ocular reflex adaptation, improve postural stability, and reduce dizziness-related symptoms.
Participants will be instructed to perform the exercises regularly, and adherence will be monitored using exercise logs.
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Активный компаратор: Control Group
Participants in this group will receive standard home-based vestibular rehabilitation exercises without additional Ai Chi intervention.
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Participants will receive a structured home-based vestibular rehabilitation program including gaze stabilization, head movement, balance, and postural control exercises.
The program aims to promote vestibulo-ocular reflex adaptation, improve postural stability, and reduce dizziness-related symptoms.
Participants will be instructed to perform the exercises regularly, and adherence will be monitored using exercise logs.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in balance performance assessed by Berg Balance Scale
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in balance performance will be assessed using the Berg Balance Scale (BBS).
The BBS consists of 14 items scored from 0 to 4, with a total score ranging from 0 to 56.
Higher scores indicate better balance performance.
balance performance will be assessed using the Berg Balance Scale in participants receiving Ai Chi-based exercise program in addition to home-based vestibular rehabilitation, compared with participants receiving home-based vestibular rehabilitation alone.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in dizziness-related disability will be assessed using the Dizziness Handicap Inventory (DHI). The DHI consists of 25 items with a total score ranging from 0 to 100. Higher scoredizziness-related disability assessed by Dizziness Handicap Inventory
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in dizziness-related disability will be assessed using the Dizziness Handicap Inventory.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in dizziness severity assessed by Vertigo Symptom Scale-Short Form
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in vestibular symptoms will be assessed using the Vestibular Symptoms Scale (VSS).
The VSS consists of 15 items evaluating the frequency of vestibular symptoms.
Each item is scored from 0 to 4, with a total score ranging from 0 to 60. Higher scores indicate more severe symptoms.
dizziness severity will be assessed using the Vertigo Symptom Scale-Short Form.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in kinesiophobia assessed by Tampa Kinesiophobia Scale
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK).
The TSK consists of 17 items scored from 1 to 4, with total scores ranging from 17 to 68.
Higher scores indicate greater fear of movement.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in quality of life assessed by Short Form-36
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in quality of life will be assessed using the Short Form-36 Health Survey (SF-36).
The SF-36 consists of 8 subscales scored from 0 to 100, with higher scores indicating better health status.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in balance confidence assessed by Activities-specific Balance Confidence Scale
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABC).
The ABC includes 16 items scored from 0% to 100%, with higher scores indicating greater balance confidence.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in functional mobility assessed by Timed Up and Go Test
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in functional mobility will be assessed using the Timed Up and Go Test (TUG).
The time required to stand up, walk 3 meters, turn, and sit down is recorded in seconds.
Lower times indicate better performance.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in tandem balance performance assessed by tandem stance/walking duration
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in dynamic balance will be assessed using tandem walking performance.
The duration or number of steps maintained in tandem stance is recorded.
Higher performance indicates better balance.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in perceived benefit assessed by Vestibular Rehabilitation Benefit Questionnaire
Временное ограничение: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Change in perceived benefit will be assessed using the Vestibular Rehabilitation Benefit Questionnaire (VRBQ).
The questionnaire evaluates symptom severity and quality of life related to vestibular dysfunction.
Raw scores are converted to percentage values ranging from 0 to 100.
Higher scores indicate greater symptom severity and poorer quality of life.
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Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Kurt EE, Buyukturan B, Buyukturan O, Erdem HR, Tuncay F. Effects of Ai Chi on balance, quality of life, functional mobility, and motor impairment in patients with Parkinson's disease<sup/> Disabil Rehabil. 2018 Apr;40(7):791-797. doi: 10.1080/09638288.2016.1276972. Epub 2017 Jan 13.
- Covill LG, Utley C, Hochstein C. Comparison of Ai Chi and Impairment-Based Aquatic Therapy for Older Adults With Balance Problems: A Clinical Study. J Geriatr Phys Ther. 2017 Oct/Dec;40(4):204-213. doi: 10.1519/JPT.0000000000000100.
- Pereira CMM, Pinheiro do Vale JS, de Oliveira WP, Pinto DDS, Cal RVR, de Azevedo YJ, Bahmad F Jr. Aquatic physiotherapy: a vestibular rehabilitation option. Braz J Otorhinolaryngol. 2021 Nov-Dec;87(6):649-654. doi: 10.1016/j.bjorl.2019.12.003. Epub 2020 Jan 13.
- Elbar O, Tzedek I, Vered E, Shvarth G, Friger M, Melzer I. A water-based training program that includes perturbation exercises improves speed of voluntary stepping in older adults: a randomized controlled cross-over trial. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):134-40. doi: 10.1016/j.archger.2012.08.003. Epub 2012 Aug 28.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Заболевания нервной системы
- Оториноларингологические заболевания
- Расстройства чувствительности
- Ушные заболевания
- Лабиринтные болезни
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Вестибулярные заболевания
- Головокружение
- Доброкачественное позиционное пароксизмальное головокружение
- Головокружение
Другие идентификационные номера исследования
- AICHI VESTIBULAR RCT 2026
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .