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Набор скоро начнётся NCT07154407

AI-assisted Masticatory Muscle Training in Patients With Schizophrenia

Без фазы С лечением Schizophrenia Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AI-assisted Mastisting Training App.
Кому может быть актуально
Состояния в реестре: Schizophrenia Disorder. Базовые параметры: от 20 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, Masticating, and Swallowing in Patients With Schizophrenia

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое AI-assisted Mastisting Training App
    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,

Первичные конечные точки

  • Anterior tongue strength [Срок оценки: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
  • Posterior tongue strength [Срок оценки: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
  • Masticatory Performace [Срок оценки: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
  • Oral Hygiene [Срок оценки: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
  • Swallowing Performance [Срок оценки: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
  • Oral Care Behaviours [Срок оценки: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
  • Cognitive Function [Срок оценки: From day 1 of enrollment to the end of the treatment period (up to 3 months)]

Критерии участия

Критерии включения

  • 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
  • Able to communicate

Критерии исключения

  • 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
  • Joining multiple Intervention Experiments simultaneously

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07154407 · KMUHIRB-F(I)-20240124

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗