- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chiu-Mieh Huang, PhD
- Phone Number: +886-2-28267362
- Email: cmhuang2021@nycu.edu.tw
Study Locations
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 112304
- National Yang Ming Chiao Tung University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Participants perform facial exercises using the Smart Facial Coaching System for approximately 10-15 minutes per day for 5 consecutive days.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial Exercise Behavior and Related Psychosocial Outcomes
Time Frame: Baseline, immediately post-intervention, and 1 month after the intervention
|
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.
|
Baseline, immediately post-intervention, and 1 month after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Repetitive Saliva Swallowing Test (RSST)
Time Frame: Baseline and immediately post-intervention
|
Assessed using the Repetitive Saliva Swallowing Test (RSST), recording the number of saliva swallows completed within 30 seconds.
|
Baseline and immediately post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chiu-Mieh Huang, PhD, National Yang Ming Chiao Tung University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NYCU115098AE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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