- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Chiu-Mieh Huang, PhD
- Numero di telefono: +886-2-28267362
- Email: cmhuang2021@nycu.edu.tw
Luoghi di studio
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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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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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Comparatore attivo: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Facial Exercise Behavior
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and immediately after completion of the 5-day intervention.
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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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Repetitive Saliva Swallowing Test (RSST)
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Chiu-Mieh Huang, PhD, National Yang Ming Chiao Tung University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- NYCU115098AE
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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