The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, Masticating, and Swallowing in Patients With Schizophrenia
Phase: NA
Conditions: Schizophrenia Disorder
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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The Official Title of the study:  
 
The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, 
Masticating, and Swallowing in Patients with Schizophrenia 
 
 
 
Date of the document: 2025/8/26 
 
 
 
 

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Study Design 
 
This study will adopt a randomized controlled experimental design with parallel 
groups. Participants will be recruited from two hospitals and randomly assigned in a 
1:1 ratio to either the experimental group or the control group. 
 
Participants 
 
Eligible participants will be adults meeting the study inclusion criteria (to be specified 
separately). A total of 100 participants will be enrolled, with 50 assigned to each 
group. 
 
Randomization and Allocation 
 
Random assignment will be performed using a computer-generated randomization 
sequence. Allocation concealment will be ensured through sealed opaque envelopes 
prepared by a research assistant not involved in recruitment or assessment. 
Interventions 
 
 
Experimental Group (n = 50): Participants will receive AI-assisted 
Masticatory Muscle Training sessions lasting 20 minutes each, administered 
before each of their three daily meals. 
 
Control Group (n = 50): Participants will continue with their routine 
scheduled daycare activities without any additional intervention. 
Outcome Measures 
 
Assessments will be conducted at baseline (T0), 3 months (T1), and 6 months (T2). 
The following variables will be measured: 
1. Plaque Index 
2. Winkle Tongue-Coating Index 
3. Dry Mouth Status 
4. Repetitive Saliva Swallowing Test (RSST) 
5. Saliva Flow Rate 

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6. Biting Force 
7. Tongue Pressure 
8. Oral Frailty Assessment 
9. Oral Diadochokinesis (DDK) 
10. Oral Care Behaviors 
 
Data Collection and Management 
 
Data will be collected by trained assessors blinded to group allocation. All data will 
be recorded in a secure electronic database with access restricted to the research team. 
Statistical Analysis 
 
Descriptive statistics will be used to summarize participant characteristics. 
Generalized Estimating Equations (GEE) will be employed to examine the effects of 
the intervention over time, accounting for repeated measures and potential covariates. 
Statistical significance will be set at p < 0.05. 
 
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