- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07700654
Smart Facial Exercise Coaching System for Older Adults
Development and Testing of a Smart Facial Coaching System for Older Adults
Participants will participate in a 5-day facial exercise program and will be assessed at baseline, immediately after completion of the intervention, and 1 month after completion of the intervention.
Older adults aged 60 years and above who are able to communicate in Mandarin or Taiwanese and who participate in activities at adult day-care centers or community care centers will be eligible for inclusion. Individuals with severe visual or hearing impairment, moderate to severe dementia, inability to communicate verbally, obvious facial wounds or lesions, or medical conditions affecting swallowing function (e.g., stroke) will be excluded from participation.
A total of approximately 130 participants will be recruited and assigned to one of two groups:
Intervention Group (n ≈ 65): Participants will perform facial exercises using the Smart Facial Coaching System.
Control Group (n ≈ 65): Participants will perform facial exercises by following a video-based facial exercise program.
After providing informed consent and meeting the eligibility criteria, participants will complete baseline assessments, including structured questionnaires and the Repetitive Saliva Swallowing Test (RSST).
Participants in both groups will then perform facial exercises for five consecutive days, with each session lasting approximately 10-15 minutes.
Upon completion of the 5-day facial exercise program, participants will complete post-intervention assessments, including structured questionnaires and the Repetitive Saliva Swallowing Test (RSST).
One month after completion of the intervention, participants will complete follow-up questionnaires assessing facial exercise behavior and psychosocial outcomes, which will take approximately 15-20 minutes.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Program description is as follows:
Intervention Group (n ≈ 65): Participants will perform facial exercises using the Smart Facial Coaching System. The program consists of four components, and each session will last approximately 10-15 minutes.
- Eye Exercises: Gentle eye closure, forceful eye closure, eye opening, and lateral eye stretching exercises to promote eye muscle activity (approximately 2-3 minutes).
- Mouth Opening Exercises: Maximum mouth opening and repetitive mouth-opening exercises to promote perioral muscle activity (approximately 3-4 minutes).
- Oral Function Exercises: Articulation exercises, cheek exercises, tongue exercises, salivary gland massage, and swallowing exercises to promote oral function (approximately 3-5 minutes).
- Smiling Exercises: Viewing happy facial expression images, facial relaxation exercises, and smile imitation exercises to promote facial muscle activity (approximately 1-2 minutes).
Control Group (n ≈ 65): Participants will perform facial exercises by following an oral health exercise video available on YouTube. The exercise program includes facial muscle exercises, tongue exercises, salivary gland massage, swallowing exercises, and articulation exercises.
YouTube video: https://youtu.be/_Q4DwWXJ4S4?si=Ld10bgiklFLwTHPc
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Chiu-Mieh Huang, PhD
- Номер телефона: +886-2-28267362
- Электронная почта: cmhuang2021@nycu.edu.tw
Места учебы
-
-
Taipei City
-
Taipei, Taipei City, Тайвань, 112304
- National Yang Ming Chiao Tung University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Willing to participate in this study voluntarily.
- Able to provide written informed consent.
- Aged 60 years or older.
- Able to communicate in Mandarin Chinese or Taiwanese.
Exclusion Criteria:
- Severe visual or hearing impairment.
- Diagnosis of moderate to severe dementia.
- Inability to communicate verbally.
- Presence of obvious structural or pathological lesions of the face.
- Diseases or conditions affecting swallowing function (e.g., stroke).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Smart Facial Coaching System
Participants perform facial exercises using the Smart Facial Coaching System for approximately 10-15 minutes per day for 5 consecutive days.
|
Participants perform facial exercises using the Smart Facial Coaching System for approximately 10-15 minutes per day for 5 consecutive days.
|
|
Активный компаратор: Video-Based Facial Exercise
Participants perform facial exercises by following a video-based facial exercise program for approximately 10-15 minutes per day for 5 consecutive days.
|
Participants perform facial exercises by following a video-based facial exercise program for approximately 10-15 minutes per day for 5 consecutive days.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Facial Exercise Behavior
Временное ограничение: Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
Assessed using a structured questionnaire evaluating facial exercise behavior.
|
Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
|
Psychosocial Outcomes Related to Facial Exercise
Временное ограничение: Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
Assessed using structured questionnaires evaluating psychosocial outcomes related to facial exercise.
|
Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
|
Eye Discomfort and Oral Function
Временное ограничение: Baseline and immediately after completion of the 5-day intervention.
|
Assessed using structured questionnaires evaluating eye discomfort symptoms and oral function.
|
Baseline and immediately after completion of the 5-day intervention.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Repetitive Saliva Swallowing Test (RSST)
Временное ограничение: Baseline and immediately after completion of the 5-day intervention.
|
Assessed using the Repetitive Saliva Swallowing Test (RSST), measuring the number of saliva swallows completed within 30 seconds.
|
Baseline and immediately after completion of the 5-day intervention.
|
Соавторы и исследователи
Следователи
- Главный следователь: Chiu-Mieh Huang, PhD, National Yang Ming Chiao Tung University
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
Другие идентификационные номера исследования
- NYCU115098AE
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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. .