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临床试验/NCT05920993
NCT05920993Enrolling By Invitation不适用

The Performances and Differences in Tongue Function Between Healthy Adults and Dysphagia in Patients With Stroke in Taiwan

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
32
试验地点
1
主要终点
To explore the differences between healthy adults and stroke patients with dysphagia in different test items, and whether there is a cut-off value between the two groups (e.g. tongue strength, tongue endurance, the pressure of swallowing saliva)

研究概览

简要总结

Cerebrovascular accident makes adults lose the ability to be independent in daily life, and a higher proportion of them will suffer from dysphagia. Previous studies pointed out that the tongue muscle strength of stroke patients is significantly lower than that of healthy adults. Furthermore, the tongue strength of stroke patients with dysphagia is significantly lower than those without dysphagia.

Many studies investigated the performance of tongue function in healthy adults or groups with dysphagia caused by different diseases. However, the current research on the performance of tongue function in healthy adults and stroke patients in Taiwan is relatively lacking. Therefore, our purpose of this study is to investigate the performance and differences of tongue function between healthy adults and strokes patients in Taiwan.

This study is expected to recruit 32 healthy adults and stroke patients in each group. The two groups will be matched with each other by gender and age (±2 years). In the study, Mann assessment of swallowing ability (MASA) will be used as an assessment tool to distinguish whether the subjects are accompany with dysphagia and the severity of dysphagia. And using Iowa Oral Performance Instrument (IOPI) to measure the value of tongue pressure. Then, analyze whether there are significant differences and the correlations. To provide clinicians with empirical data for early detection and intervention of swallowing.

详细描述

Stroke is one of the causes of disability in adults, and it is easy for patients to lose their ability to be independent in daily life. There are researchers used the Taiwan Stroke Registration Database to investigate the proportion of patients with disability after the first stroke , found that the disability rate was 61.2% one month after stroke, 55.58% after three months, and 51.72% after six months. In addition to changes in consciousness, motor dysfunction, and aphasia, common problems after stroke can also cause dysphagia. Studies have shown that about 51%-55% of patients with acute stroke will be accompanied by dysphagia.

A systematic review showed that patients with dysphagia had a 3-fold higher risk of developing pneumonia (RR=3.17; 95% CI, 2.07, 4.87) than those without 11 times more than those with disabilities (RR=11.56; 95% CI, 3.36, 39.77). Previous study collected the data of 1220 stroke patients in Taiwan from the National Health Insurance Database, divided them into dysphagia group and non-swallowing disorder group, and matched each other by age and sex, and tracked the mortality and aspiration after five years. The incidence of pneumonia, the results of the study showed that after the first year of stroke, the incidence of aspiration pneumonia in the dysphagia group was 4.69 times that of the non-swallowing disorder group, and the five-year mortality rate of the dysphagia group was higher than that of the non-swallowing disorder group 1.84 times. It can be seen that dysphagia has a great impact on stroke patients, even life-threatening.

There are four stages of swallowing, which are the oral preparation stage, oral stage, pharyngeal stage, and esophageal stage. Each stage has its own function, and the tongue plays an important role in the oral stage. It not only provides taste, can also assist chewing, and send the bolus to the pharynx after the bolus is formed, in order to transport the bolus from the oral cavity to the Adequate tongue muscle strength is required in the pharynx, and sufficient tongue muscle strength also prevents vallecular residue after swallowing.

Previous studies have pointed out that the tongue muscle strength of stroke patients is significantly lower than that of healthy adults, and the tongue muscle strength of stroke patients with swallowing disorders is significantly lower than that of stroke patients without swallowing disorders. There are other studies that compare the differences in tongue muscle strength between patients with dysphagia and healthy adults, and even further explore whether there is a cut-off value between the two, so as to provide clinical staff with early detection and intervention for different groups of dysphagia Empirical data.

In order to objectively understand tongue function and strength, many foreign studies have used the Iowa Oral Performance Instrument (IOPI) to explore tongue-related abilities and performance, and to further establish the relationship between tongue muscle strength and tongue endurance in healthy adults. Norm data, and then use this norm to assess whether patients have tongue weakness or as a target reference value for tongue movement planning. In addition to measuring tongue muscle strength and tongue endurance, some scholars also explore the performance of tongue muscle strength when healthy adults swallow liquids of different textures or volumes, as well as dry swallowing and Tongue muscle strength performance when drinking water.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with dysphagia after stroke:
  • People who recently felt difficulty in swallowing or coughing before/during/after eating or drinking.
  • Over the age of 20
  • Clear consciousness and can complete the following three instructions
  • Is it morning, afternoon or evening?
  • Where is this place?
  • Pease handing me the pen and then point to the ceiling
  • People who have been diagnosed with cerebrovascular disease by a physician
  • MASA total score less than 178 points
  • Healthy adults:
  • People who have not been diagnosed with cerebrovascular disease by a physician
  • Over the age of 20
  • Clear consciousness and can complete the following three instructions
  • Is it morning, afternoon or evening?
  • Where is this place?
  • Pease handing me the pen and then point to the ceiling
  • People who have been diagnosed with cerebrovascular disease by a physician
  • MASA total score is above 178 points

排除标准

  • People with a history of neurodegenerative diseases, brain injuries, head and neck cancers, or those who have undergone head and neck surgery

结局指标

主要结局

To explore the differences between healthy adults and stroke patients with dysphagia in different test items, and whether there is a cut-off value between the two groups (e.g. tongue strength, tongue endurance, the pressure of swallowing saliva)

时间窗: up to 3 months

After completing the above testing items, the statistical method of independent-samples t-test can be used to analyze the data. Based on the analysis results, the numerical values of each observed variable can be compared with the MASA (Modified Ashworth Scale Assessment) scores using Receiver Operating Characteristic (ROC) analysis. Furthermore, the analysis can include the calculation of the Area Under Curve (AUC), sensitivity, specificity, and determination of cut-off points.

次要结局

  • In a group of healthy adults, explore the correlation between age and sex and test items.(up to 3 months)
  • Explore the correlation between the severity of swallowing disorders (mild, moderate, severe) and the test items.(up to 3 months)
  • In the group of patients with dysphagia after stroke, explore the correlation between age and sex and the test items.(up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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