- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Chiu-Mieh Huang, PhD
- Número de telefone: +886-2-28267362
- E-mail: cmhuang2021@nycu.edu.tw
Locais de estudo
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Taipei City
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Taipei, Taipei City, Taiwan, 112304
- National Yang Ming Chiao Tung University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Facial Exercise Behavior
Prazo: 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
Prazo: 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.
|
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Eye Discomfort and Oral Function
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Repetitive Saliva Swallowing Test (RSST)
Prazo: 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.
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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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- NYCU115098AE
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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