- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07700654
Smart Facial Exercise Coaching System for Older Adults
Development and Testing of a Smart Facial Coaching System for Older Adults
Participants will be invited to take part in a facial exercise program and will be assessed before the intervention, immediately after the intervention, and one month after 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 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 the structured questionnaires and perform the Repetitive Saliva Swallowing Test (RSST).
One month after the intervention, participants will complete a follow-up questionnaire, which will take approximately 15-20 minutes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Chiu-Mieh Huang, PhD
- Telefonnummer: +886-2-28267362
- E-mail: cmhuang2021@nycu.edu.tw
Studiesteder
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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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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Facial Exercise Behavior and Related Psychosocial Outcomes
Tidsramme: Baseline, immediately post-intervention, and 1 month after the intervention
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Assessed using structured questionnaires measuring facial exercise behavior and related psychosocial outcomes, including eye discomfort, oral function, attitudes toward facial exercise, decisional balance, self-efficacy, and well-being.
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Baseline, immediately post-intervention, and 1 month after the intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Repetitive Saliva Swallowing Test (RSST)
Tidsramme: Baseline and immediately post-intervention
|
Assessed using the Repetitive Saliva Swallowing Test (RSST), recording the number of saliva swallows completed within 30 seconds.
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Baseline and immediately post-intervention
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Chiu-Mieh Huang, PhD, National Yang Ming Chiao Tung University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NYCU115098AE
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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