- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Chiu-Mieh Huang, PhD
- Telefonnummer: +886-2-28267362
- E-post: cmhuang2021@nycu.edu.tw
Studieorter
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 112304
- National Yang Ming Chiao Tung University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
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.
|
Participants perform facial exercises by following a video-based facial exercise program for approximately 10-15 minutes per day for 5 consecutive days.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Facial Exercise Behavior
Tidsram: Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
Assessed using a structured questionnaire evaluating facial exercise behavior.
|
Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
|
Psychosocial Outcomes Related to Facial Exercise
Tidsram: Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
Assessed using structured questionnaires evaluating psychosocial outcomes related to facial exercise.
|
Baseline, immediately after completion of the 5-day intervention, and 1 month after completion of the intervention.
|
|
Eye Discomfort and Oral Function
Tidsram: Baseline and immediately after completion of the 5-day intervention.
|
Assessed using structured questionnaires evaluating eye discomfort symptoms and oral function.
|
Baseline and immediately after completion of the 5-day intervention.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Repetitive Saliva Swallowing Test (RSST)
Tidsram: 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.
|
Baseline and immediately after completion of the 5-day intervention.
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Chiu-Mieh Huang, PhD, National Yang Ming Chiao Tung University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NYCU115098AE
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