- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07778654
Vestibular Stimulation Versus Foot Intrinsic Muscle Exercises in Children With Down Syndrome (VESTIB-FIME)
Effects of Vestibular Stimulation VS Foot Intrinsic Muscles Exercises on Balance and Functional Mobility in Children With Down's Syndrome
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Down syndrome (DS) is a genetic disorder commonly associated with hypotonia, ligamentous laxity, impaired postural control, motor incoordination, and balance difficulties. These impairments can negatively affect functional mobility and participation in activities of daily living. Balance is one of the major functional domains affected in children and adolescents with Down syndrome. Postural instability may result in increased displacement of the center of mass during gait and center of pressure during standing, which can further affect gait performance, transfers, and other functional activities.
Pes planus (flat foot) is also frequently observed in individuals with Down syndrome and may contribute to impaired balance, physical activity, and quality of life. Vestibular stimulation exercises (VSE) provide repetitive sensory information regarding body position, movement, and orientation in space and may improve postural control and balance. Similarly, foot intrinsic muscle exercises (FIMEs) aim to strengthen the muscles responsible for foot stability and may improve foot function, postural control, gait, and functional mobility.
Previous studies have reported beneficial effects of vestibular stimulation and foot intrinsic muscle exercises when used independently in individuals with Down syndrome or balance-related impairments. However, there is limited research directly comparing these two approaches in children with Down syndrome. Therefore, this study will compare the effects of vestibular stimulation exercises and foot intrinsic muscle exercises on balance and functional mobility in children aged 4-15 years with Down syndrome.
Balance will be assessed using the Pediatric Balance Scale (PBS), while functional mobility will be evaluated using the Timed Up and Go (TUG) test. The study aims to determine which intervention provides greater improvement in balance and functional mobility. The findings may help physiotherapists and rehabilitation professionals select an appropriate exercise approach for children with Down syndrome and contribute to the development of more effective pediatric rehabilitation strategies.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: laiba shad, DPT
- Номер телефона: 03066493073
- Электронная почта: laibashad27@gmail.com
Учебное резервное копирование контактов
- Имя: arooj hanif, DPT
- Номер телефона: 03206550216
- Электронная почта: aroojhanif6@gmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- • Children with Down syndrome with age range (4-15 years) both male and female children included [12]. • Children who are able to stand and walk/ambulate independently and follow verbal instructions and commands and comply with intervention protocol [13]. • No visual and hearing impairment • Parent/guardian willing to provide consent for participant
Exclusion Criteria:
- Associated congenital heart disease • Hearing impairment, eye problems such as cataract or other visual impairment • Dementia and cognitive decline. • Lower limb trauma or surgical intervention within the previous 6 months affecting comprehension or ability to perform balance/mobility activities [13]
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: Vestibular Stimulation Exercise Group
Participants in this group will receive vestibular stimulation exercises 3 times per week for 8 weeks, for a total of 24 sessions.
Each session will last 20 minutes, with a 5-minute rest interval.
The intervention will include spinning while sitting on a Swiss ball, sliding while lying on a large roller pillow, and vertical bouncing while sitting on a roller.
Balance and functional mobility will be assessed at baseline (Week 0), immediately after the intervention (Week 8), and at follow-up (Week 12).
Balance will be measured using the Pediatric Balance Scale (PBS), and functional mobility will be assessed using the Timed Up and Go (TUG) test.
|
A structured vestibular stimulation exercise program designed to improve postural control, balance, and functional mobility in children with Down syndrome.
The program includes sensory-motor activities involving controlled rotational, linear, and vertical movements.
Другие имена:
|
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Экспериментальный: Foot Intrinsic Muscle Exercises
Participants in this group will receive foot intrinsic muscle exercises 3 times per week for 8 weeks, for a total of 24 sessions.
Each session will last 20 minutes, with a 5-minute rest interval.
The intervention will include toe curls, marble pickups, short foot exercises, ball rolling, heel raises, step-ups, and football kicking.
Seated calf stretching will be performed as a warm-up and cool-down before and after strengthening exercises.
Balance and functional mobility will be assessed at baseline (Week 0), immediately after the intervention (Week 8), and at follow-up (Week 12).
Balance will be measured using the Pediatric Balance Scale (PBS), and functional mobility will be assessed using the Timed Up and Go (TUG) test.
|
A structured foot muscle strengthening program designed to improve foot stability, postural control, balance, and functional mobility in children with Down syndrome.
The program targets the intrinsic muscles of the foot through functional strengthening activities.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Balance Measured by the Pediatric Balance Scale (PBS)
Временное ограничение: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
|
Balance will be assessed using the Pediatric Balance Scale (PBS), a 14-item clinical measure of functional balance in children.
The total score ranges from 0 to 56, with higher scores indicating better balance.
The change in PBS score from baseline will be evaluated to determine the effect of the interventions on balance.
|
Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test
Временное ограничение: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
|
Functional mobility will be assessed using the Timed Up and Go (TUG) test.
The TUG measures the time, in seconds, required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
A shorter completion time indicates better functional mobility.
The change in TUG completion time from baseline will be evaluated.
|
Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
|
Соавторы и исследователи
Следователи
- Учебный стул: DR SADAF TABASSAM, PHD, Shalamar Hospital
Публикации и полезные ссылки
Общие публикации
- Bu Q, Qiang R, Cheng H, et al. Front Pediatr. 2022;10:882722. Khan F, Rahiyab M, Hussain I, et al. Int Health Rev. 2025;5(2):19-44. Giustino V, Messina G, Alesi M, et al. Hum Mov. 2021;22(1):66-71. Nahla IM, El-Sayed SE, Ragaa AE, et al. Afr Health Sci. 2022;22(1):377-383. Tuncer D, Erekdag A, Senaran H, et al. Eur J Pediatr. 2025;184:636. Halwsh SD, Algabbani MF, Alqabbani S, et al. Brain Sci. 2026;16(1):79. Siddiqui M, Farooqui S, Rizvi J, et al. Ann King Edward Med Univ. 2024;30(2):112-118. Ghouri EURK, Memon AG, Ali S, et al. J Liaquat Univ Med Health Sci. 2024;23(2):116-120. Adeeba N, Farooqui SI, Hasan ZM, et al. Dev Neurorehabil. 2024;27(5-6):145-153.
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
- Генетические заболевания, врожденные
- Нейроповеденческие проявления
- Врожденные аномалии
- Аномалии, Множественные
- Интеллектуальная недееспособность
- Хромосомные нарушения
- Врожденные, наследственные и неонатальные заболевания и аномалии
- Синдром Дауна
Другие идентификационные номера исследования
- SSAHS-2026-1126
Планирование данных отдельных участников (IPD)
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Описание плана IPD
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. .