Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05920993
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-27
First Post:
2023-03-06
Brief Title:
The Performances and Differences in Tongue Function Between Healthy Adults and Dysphagia in Patients With Stroke in Taiwan
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Performances and Differences in Tongue Function Between Healthy Adults and Dysphagia in Patients With Stroke in Taiwan
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 612 one month after stroke 5558 after three months and 5172 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 RR317 95 CI 207 487 than those without 11 times more than those with disabilities RR1156 95 CI 336 3977 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 469 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 184 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
There is a close correlation between muscle strength and skeletal muscle mass and the reduction of skeletal muscle mass will lead to a decrease in muscle strength especially after the age of 27 skeletal muscle mass and age begin to show a negative correlation that is As a result skeletal muscle mass gradually decreases with age In addition to age skeletal muscle mass also varies with race Some researchers explored the correlation between race and skeletal muscle mass pointing out that African Americans have the largest skeletal muscle mass and then This trend was observed for comparisons of skeletal muscle mass size in Caucasians Hispanics and finally Asians regardless of male or female
According to past studies on tongue muscle strength from the same age range and gender the tongue muscle strength data of healthy adults in different countries are different which may be caused by racial differences The data on adult tongue muscle strength and tongue endurance can provide a reference but considering the differences in race and nationality it is impossible to apply foreign tongue muscle strength standards to healthy adults in Taiwan Due to the lack of research data on the tongue function performance of healthy adults and stroke patients in Taiwan we do not know whether there are differences or correlations between them nor do we know the physiological values related to different degrees of swallowing disorders and tongue muscle strength What is the relevance of Therefore the main motivation of this study is to explore the tongue function performance and differences between healthy adults and stroke patients
This study aims to investigate the tongue functional performance and differences between healthy adults and stroke patients in Taiwan On the one hand we want to understand the functional performance and whether there are differences between the two as well as the correlation between different degrees of swallowing disorders and tongue pressure measurement items On the other hand it also collects tongue performance data in Taiwan to provide clinical personnel as a reference
The research questions are as follows
1 In a group of healthy adults explore the correlation between age and sex and test items
eg tongue strength tongue endurance the pressure of swallowing saliva 3-ml water and fluids of varying textures and volumes
2 In the group of patients with stroke and dysphagia explore the correlation between age and sex and the test items
eg tongue strength tongue endurance the pressure of swallowing saliva
3 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 eg tongue strength tongue endurance the pressure of swallowing saliva
4 Explore the correlation between the severity of swallowing disorders mild moderate severe and the test items
eg tongue strength tongue endurance the pressure of swallowing saliva
The definition of fluids of varying textures In order to make each texture deployment have a standardized procedure this research uses International Dysphagia Diet Standardisation Initiative IDDSI as the basis for the consistency of the preparation and the thickener brand Neo-High Toromeal is added to the water as the swallowing food Using IDDSI level 2 mildly thick level 3 moderately thick level 4 pureed to measure the swallowing tongue muscle strength of healthy adults
The definition of fluids of varying volumes Divide the volume of each texture into 5ml 10ml and 15ml to measure the pressure of tongue muscle of healthy adults in sequence
A systematic review showed that patients with dysphagia had a 3-fold higher risk of developing pneumonia RR317 95 CI 207 487 than those without 11 times more than those with disabilities RR1156 95 CI 336 3977 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 469 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 184 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
There is a close correlation between muscle strength and skeletal muscle mass and the reduction of skeletal muscle mass will lead to a decrease in muscle strength especially after the age of 27 skeletal muscle mass and age begin to show a negative correlation that is As a result skeletal muscle mass gradually decreases with age In addition to age skeletal muscle mass also varies with race Some researchers explored the correlation between race and skeletal muscle mass pointing out that African Americans have the largest skeletal muscle mass and then This trend was observed for comparisons of skeletal muscle mass size in Caucasians Hispanics and finally Asians regardless of male or female
According to past studies on tongue muscle strength from the same age range and gender the tongue muscle strength data of healthy adults in different countries are different which may be caused by racial differences The data on adult tongue muscle strength and tongue endurance can provide a reference but considering the differences in race and nationality it is impossible to apply foreign tongue muscle strength standards to healthy adults in Taiwan Due to the lack of research data on the tongue function performance of healthy adults and stroke patients in Taiwan we do not know whether there are differences or correlations between them nor do we know the physiological values related to different degrees of swallowing disorders and tongue muscle strength What is the relevance of Therefore the main motivation of this study is to explore the tongue function performance and differences between healthy adults and stroke patients
This study aims to investigate the tongue functional performance and differences between healthy adults and stroke patients in Taiwan On the one hand we want to understand the functional performance and whether there are differences between the two as well as the correlation between different degrees of swallowing disorders and tongue pressure measurement items On the other hand it also collects tongue performance data in Taiwan to provide clinical personnel as a reference
The research questions are as follows
1 In a group of healthy adults explore the correlation between age and sex and test items
eg tongue strength tongue endurance the pressure of swallowing saliva 3-ml water and fluids of varying textures and volumes
2 In the group of patients with stroke and dysphagia explore the correlation between age and sex and the test items
eg tongue strength tongue endurance the pressure of swallowing saliva
3 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 eg tongue strength tongue endurance the pressure of swallowing saliva
4 Explore the correlation between the severity of swallowing disorders mild moderate severe and the test items
eg tongue strength tongue endurance the pressure of swallowing saliva
The definition of fluids of varying textures In order to make each texture deployment have a standardized procedure this research uses International Dysphagia Diet Standardisation Initiative IDDSI as the basis for the consistency of the preparation and the thickener brand Neo-High Toromeal is added to the water as the swallowing food Using IDDSI level 2 mildly thick level 3 moderately thick level 4 pureed to measure the swallowing tongue muscle strength of healthy adults
The definition of fluids of varying volumes Divide the volume of each texture into 5ml 10ml and 15ml to measure the pressure of tongue muscle of healthy adults in sequence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None