AI-assisted Masticatory Muscle Training in Patients With Schizophrenia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Psychiatric Outpatient Ward Schizophrenia Diagnosed patient with 20 years or above

Without Violence or suicidal tendencies

With a self-owned smartphone

Able to stabilise the IOPI machine while testing

Disqualifiers

Severe psychiatric symptoms

With medical history which affects oral hygiene and masticating function severely (such as stroke, oral cavity-related cancer, periodontitis)

Severe cognitive function with a score of less than 16 marks in the MoCA Test

Indicated with Motor Neuron Disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-assisted Mastisting Training App

    Other intervention

    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,

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervented groupExperimental treatment 1 intervention
Group B: Controlled groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From day 1 of enrollment to the end of the treatment period (up to 3 months)
2

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

Time frame
From day 1 of enrollment to the end of the treatment period (up to 3 months)
3

Masticatory Performace

Using colour-changing chewing gum to assess the ability, the colour would be changed according to the frequency of chewing

Time frame
From day 1 of enrollment to the end of the treatment period (up to 3 months)
4

Oral Hygiene

Using the Plaque index, Winkle tongue-coating index to assess participants' oral hygiene

Time frame
From day 1 of enrollment to the end of the treatment period (up to 3 months)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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