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Dysphagia seems to be quite common and potentially severe in schizophrenia, which may lead to acute asphyxia or pneumonia. Dysphagia in schizophrenia could be associated with drug-induced Parkinsonism, dystonia, tardive dyskinesia, dry mouth, excessive saliva, and other complications. Inadequate oral hygiene may lead to the accumulation of plaque, which can cause oral diseases and consequently result in tooth loss. This could be one of the significant factors affecting impaired masticating and swallowing abilities.
An experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=50), and control group (n=50). The experimental group will receive 'AI-assisted Masticatory Muscle Training' sessions, each lasting 20 minutes, before each of their three daily meals. The plaque index, Winkle tongue-coating index, dry mouth, repetitive saliva swallowing, saliva flow rate, biting force, tongue pressure, oral frailty, RSST, DDK, and oral care behaviors were assessed at baseline, as well as during the 3-month follow-ups.
Dysphagia seems to be quite common and potentially severe in schizophrenia, which may lead to acute asphyxia or pneumonia. Dysphagia in schizophrenia could be associated with drug-induced Parkinsonism, dystonia, tardive dyskinesia, dry mouth, excessive saliva, and other complications. Inadequate oral hygiene may lead to the accumulation of plaque, which can cause oral diseases and consequently result in tooth loss. This could be one of the significant factors affecting impaired masticating and swallowing abilities.
An experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=50), and control group (n=50). The experimental group will receive 'AI-assisted Masticatory Muscle Training' sessions, each lasting 20 minutes, before each of their three daily meals. The control group will be maintained their scheduled activities in daycare as usual. The plaque index, Winkle tongue-coating index, dry mouth, repetitive saliva swallowing, saliva flow rate, biting force, tongue pressure, oral frailty, RSST, DDK, and oral care behaviors were assessed at baseline, as well as during the 3-month follow-ups. Generalized Estimating Equations (GEE) were used to analyses the indicated effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervented group | Experimental | The group member (n=50) will receive 'AI-assisted Masticatory Muscle Training' sessions, each lasting 20 minutes, before each of their three daily meals. The plaque index, Winkle tongue-coating index, dry mouth, repetitive saliva swallowing, saliva flow rate, biting force, tongue pressure, oral frailty, RSST, DDK, and oral care behaviors were assessed at baseline, as well as during the 3-month and 6-month follow-ups. |
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| Controlled group | No Intervention | The control group (n=50) will be maintained their scheduled activities in daycare as usual. The plaque index, Winkle tongue-coating index, dry mouth, repetitive saliva swallowing, saliva flow rate, biting force, tongue pressure, oral frailty, RSST, DDK, and oral care behaviors were assessed at baseline, as well as during the 3-month and 6-month follow-ups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted Mastisting Training App | Other | An artificial intelligence (AI) recognition system for the 'AI-assisted Masticatory Muscle Training,' tailored to train masticatory muscles in patients with schizophrenia. By finishing certain exercise per day, expecting the experimental oral hygience, masticating and swallowing fuction could be advanced, |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior tongue strength | Using the IPOI machine to test participants' tongue strength once a month for a total of 3 months, and a follow-up review 3 months after the end of treatment | From day 1 of enrollment to the end of the treatment period (up to 3 months) |
| Posterior tongue strength | Using the IPOI machine to test participants' tongue strength once a month for a total of 3 months, and a follow-up review 3 months after the end of treatment | From day 1 of enrollment to the end of the treatment period (up to 3 months) |
| Masticatory Performace | Using colour-changing chewing gum to assess the ability, the colour would be changed according to the frequency of chewing | From day 1 of enrollment to the end of the treatment period (up to 3 months) |
| Oral Hygiene | Using the Plaque index, Winkle tongue-coating index to assess participants' oral hygiene | From day 1 of enrollment to the end of the treatment period (up to 3 months) |
| Swallowing Performance | Using the Repetitive Saliva Swallowing Test to assess the ability to swallow. The times of participants swallowed within 30 seconds would be recorded | From day 1 of enrollment to the end of the treatment period (up to 3 months) |
| Oral Care Behaviours | Using a survey to collect participants' behaviours | From day 1 of enrollment to the end of the treatment period (up to 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsieh Hsiu Fen, PhD | Contact | 886-312-1101 | 2626 | hsiufen96@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hsieh Hsiu Fen, PhD | Kaohsiung medical university nursing faculty | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2025 | Aug 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Cognitive Function |
Using MoCA to assess cognitive ability once at the beginning of the experiment |
| From day 1 of enrollment to the end of the treatment period (up to 3 months) |