The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, Masticating, and Swallowing in Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Anterior tongue strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Anterior tongue strength
时间窗: From day 1 of enrollment to the end of the treatment period (up to 3 months)
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
时间窗: From day 1 of enrollment to the end of the treatment period (up to 3 months)
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
时间窗: From day 1 of enrollment to the end of the treatment period (up to 3 months)
Using colour-changing chewing gum to assess the ability, the colour would be changed according to the frequency of chewing
Oral Hygiene
时间窗: From day 1 of enrollment to the end of the treatment period (up to 3 months)
Using the Plaque index, Winkle tongue-coating index to assess participants' oral hygiene
Swallowing Performance
时间窗: From day 1 of enrollment to the end of the treatment period (up to 3 months)
Using the Repetitive Saliva Swallowing Test to assess the ability to swallow. The times of participants swallowed within 30 seconds would be recorded
Oral Care Behaviours
时间窗: From day 1 of enrollment to the end of the treatment period (up to 3 months)
Using a survey to collect participants' behaviours
Cognitive Function
时间窗: From day 1 of enrollment to the end of the treatment period (up to 3 months)
Using MoCA to assess cognitive ability once at the beginning of the experiment
次要结局
未报告次要终点
