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Набор скоро начнётся NCT07700654

Smart Facial Exercise Coaching System for Older Adults

Без фазы С лечением Aging

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Smart Facial Coaching System, Video-Based Facial Exercise.
Кому может быть актуально
Состояния в реестре: Aging. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Development and Testing of a Smart Facial Coaching System for Older Adults

Обзор

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.

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

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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.

Первичные конечные точки

  • Facial Exercise Behavior [Срок оценки: Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.]
  • Psychosocial Outcomes Related to Facial Exercise [Срок оценки: Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.]
  • Eye Discomfort and Oral Function [Срок оценки: Baseline and immediately after completion of the 5-day intervention.]
Вторичные конечные точки (1)
  • Repetitive Saliva Swallowing Test (RSST) [Срок оценки: Baseline and immediately after completion of the 5-day intervention.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Тайвань · 1 центр
  • National Yang Ming Chiao Tung University — Taipei

Идентификаторы

NCT: NCT07700654 · NYCU115098AE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗