- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chiu-Mieh Huang, PhD
- Número de teléfono: +886-2-28267362
- Correo electrónico: cmhuang2021@nycu.edu.tw
Ubicaciones de estudio
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Taipei City
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Taipei, Taipei City, Taiwán, 112304
- National Yang Ming Chiao Tung University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
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Participants perform facial exercises using the Smart Facial Coaching System for approximately 10-15 minutes per day for 5 consecutive days.
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Comparador activo: 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.
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Participants perform facial exercises by following a video-based facial exercise program for approximately 10-15 minutes per day for 5 consecutive days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Facial Exercise Behavior
Periodo de tiempo: Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
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Assessed using a structured questionnaire evaluating facial exercise behavior.
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Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
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Psychosocial Outcomes Related to Facial Exercise
Periodo de tiempo: Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
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Assessed using structured questionnaires evaluating psychosocial outcomes related to facial exercise.
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Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
|
Eye Discomfort and Oral Function
Periodo de tiempo: Baseline and immediately after completion of the 5-day intervention.
|
Assessed using structured questionnaires evaluating eye discomfort symptoms and oral function.
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Baseline and immediately after completion of the 5-day intervention.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Repetitive Saliva Swallowing Test (RSST)
Periodo de tiempo: Baseline and immediately after completion of the 5-day intervention.
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Assessed using the Repetitive Saliva Swallowing Test (RSST), measuring the number of saliva swallows completed within 30 seconds.
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Baseline and immediately after completion of the 5-day intervention.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chiu-Mieh Huang, PhD, National Yang Ming Chiao Tung University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NYCU115098AE
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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