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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
AI-assisted Mastisting Training App
Other interventionAn 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
Trial outcomes
Primary outcomes
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
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
Masticatory Performace
Using colour-changing chewing gum to assess the ability, the colour would be changed according to the frequency of chewing
Oral Hygiene
Using the Plaque index, Winkle tongue-coating index to assess participants' oral hygiene
Locations
Sponsors and contacts
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