- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07775183
The Effects of Light-Targeted Balance Training on Balance, Functional Performance, and Fear of Falling in Individuals With a History of Falls
The Effects of Light-Targeted Balance Training on Balance, Functional Performance, and Fear of Falling in Individuals With a History of Falls: A Randomized Controlled Trial
In recent years, exercise programs based on visual stimuli have been reported to improve balance and motor control . However, studies investigating the effects of light-targeted balance training on balance, functional performance, and fear of falling in individuals with a history of falls are limited.
The aim of this study is to determine the effects of light-targeted balance training on balance, functional performance, and fear of falling in individuals with a history of falls. In addition, the study aims to investigate whether this training method provides additional benefits compared with traditional balance training. The findings of this study are expected to contribute to the development of rehabilitation programs aimed at preventing falls.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Inclusion Criteria
- Having experienced at least one fall within the previous 12 months.
- Being 18 years of age or older.
- Being able to walk independently or with the assistance of a walking aid.
- Being able to understand and follow verbal and visual instructions.
- Providing voluntary consent to participate in the study and signing the informed consent form.
Exclusion Criteria
- Presence of an acute orthopedic injury or an active musculoskeletal condition causing pain.
- Having undergone lower extremity surgery within the previous 6 months.
- Having advanced neurological disorders (e.g., advanced Parkinson's disease, advanced dementia).
- Having severe vestibular dysfunction or significant visual impairment.
- Having a cardiovascular condition that contraindicates exercise.
- Having advanced systemic diseases that significantly impair balance.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Shirin Khezritomatari
- Номер телефона: +905342494709
- Электронная почта: shirin.khezry8401@gmail.com
Места учебы
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Istanbul
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Istanbul, Istanbul, Турция (Туркие), 34000
- Рекрутинг
- Uskudar University
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Контакт:
- Shirin Khezritomatari, Master student
- Номер телефона: +905342494709
- Электронная почта: Shirin.khezry8401@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- History of at least one fall within the past 12 months
- Age 18 years or older
- Ability to walk independently or with an assistive device
- Ability to understand and follow verbal and visual instructions
- Voluntary participation in the study and provision of written informed consent by signing the informed consent form
Exclusion Criteria:
- Acute orthopedic injury or an active musculoskeletal condition causing pain
- History of lower extremity surgery within the past 6 months
- Advanced neurological disorders (e.g., advanced Parkinson's disease, advanced dementia)
- Severe vestibular dysfunction or significant visual impairment
- Medical conditions that contraindicate exercise due to severe cardiovascular disease
- Advanced systemic diseases that severely affect balance
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental Group
Participants in this group will receive light-targeted balance training in addition to the standard program.
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Exercises aimed at improving coordination, balance, and functional performance using visual and auditory cues.
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Активный компаратор: Control Group
Participants in this group will receive standard balance exercises.
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Conventional balance training exercises.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Balance Performance (Berg Balance Scale)
Временное ограничение: Baseline and after 8 weeks of intervention
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Balance performance is assessed using the Berg Balance Scale (BBS).
The scale consists of 14 functional tasks scored from 0 to 4. The total score ranges from 0 to 56, where higher scores indicate better balance and lower fall risk.
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Baseline and after 8 weeks of intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Functional Mobility (Timed Up and Go Test - TUG)
Временное ограничение: Baseline and after 8 weeks of intervention
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Dynamic balance and mobility are assessed using the Timed Up and Go (TUG) test.
The time (in seconds) taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down is recorded.
Shorter completion times indicate better mobility.
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Baseline and after 8 weeks of intervention
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Change in Dynamic Balance (Y-Balance Test)
Временное ограничение: Baseline and after 8 weeks of intervention
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Dynamic postural control is evaluated using the Y-Balance Test (YBT) in anterior, posteromedial, and posterolateral reach directions for both lower extremities.
Reach distance is normalized to limb length ((reach distance / limb length) x 100) and composite scores are calculated.
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Baseline and after 8 weeks of intervention
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Change in Lower Body Strength (30-Second Chair Stand Test)
Временное ограничение: Baseline and after 8 weeks of intervention
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Lower extremity functional muscle strength is measured using the 30-Second Chair Stand Test.
The total number of full stands completed from a seated position in 30 seconds is recorded.
A higher number of repetitions indicates greater lower body strength.
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Baseline and after 8 weeks of intervention
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Change in Gait Speed (10-Meter Walk Test - 10MWT)
Временное ограничение: Baseline and after 8 weeks of intervention
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Walking speed is assessed using the 10-Meter Walk Test (10MWT).
Participants walk a 10-meter course at their comfortable and/or fast walking pace, and the time taken (in seconds) to traverse the intermediate 6 meters is recorded to calculate gait speed (m/s).
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Baseline and after 8 weeks of intervention
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Change in Fear of Falling (Falls Efficacy Scale-International - FES-I)
Временное ограничение: Baseline and after 8 weeks of intervention
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Fear of falling is evaluated using the 16-item Falls Efficacy Scale-International (FES-I).
Each item is scored on a 4-point Likert scale from 1 (not at all concerned) to 4 (very concerned).
Total score ranges from 16 to 64, with higher scores reflecting greater fear of falling.
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Baseline and after 8 weeks of intervention
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Change in Balance Confidence (Activities-specific Balance Confidence Scale - ABC)
Временное ограничение: Baseline and after 8 weeks of intervention
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Balance confidence is measured using the 16-item Activities-specific Balance Confidence (ABC) Scale.
Participants rate their confidence in performing specific activities without losing balance on a scale from 0% to 100%.
The overall score is the mean percentage across all items.
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Baseline and after 8 weeks of intervention
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Ключевые слова
Другие идентификационные номера исследования
- 61351342/020-2288
Планирование данных отдельных участников (IPD)
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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. .