Cerebrovascular AccidentNCT05920993
The Performances and Differences in Tongue Function Between Healthy Adults and Dysphagia in Patients With Stroke in Taiwan
An observational study of Cerebrovascular Accident and Healthy Adults, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident, Healthy Adults
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jan 2023to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was divided into two groups, patients with dysphagia after stroke and healthy adults. One group had normal oral motor function, and the other was identified as demonstrating signs of dysphagia caused by cerebrovascular disease. Stroke subjects with dysphagia will be referred by speech-language therapists at National Taiwan University Hospital. Healthy adult subjects will be surveyed by researcher who are age(±2) and sex-matched to stroke patients.
Who may be able to join
- 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?
Show all 18Show fewer
- 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
Who cannot join
- People with a history of neurodegenerative diseases, brain injuries, head and neck cancers, or those who have undergone head and neck surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
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:
- In a group of healthy adults, explore the correlation between age and sex and test items. (e.g. tongue strength, tongue endurance, the pressure of swallowing saliva, 3-ml water and fluids of varying textures and volumes).
- In the group of patients with stroke and dysphagia, explore the correlation between age and sex and the test items. (e.g. tongue strength, tongue endurance, the pressure of swallowing saliva)
- 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)
- Explore the correlation between the severity of swallowing disorders (mild, moderate, severe) and the test items. (e.g. 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.
- Conditions
- Cerebrovascular Accident, Healthy Adults
- Keywords
- tongue strength, healthy adults, tongue function, differences, correlations
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Measures of tongue function were collected from two groups of individuals(healthy adults and stroke patients with dysphagia ). The items of measurement about healthy adults are the maximal tongue pressure, tongue endurance, and lingual swallowing pressures of saliva, 3-ml water, IDDSI 2, IDDSI3, and IDDSI 4 liquids. | |
| Stroke patients with dysphagia | The items of measurement about stroke patients with dysphagia are the maximal tongue pressure, tongue endurance, and lingual swallowing pressures of saliva. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: up to 3 months
Secondary outcomes (3)
In a group of healthy adults, explore the correlation between age and sex and test items.
The investigator used the Iowa Oral Performance Instrument (IOPI) to measure the maximum tongue muscle strength in with dysphagia after stroke and healthy adults. The measurement of maximum tongue muscle strength was conducted in peak mode. The examiner placed the tongue pressure bulb on the participant's tongue surface according to the testing sequence and instructed the participant not to move the tongue pressure bulb. Then, the participant was asked to exert maximum upward pressure on the hard palate with their tongue for approximately 2 seconds.
About the swallowing of saliva and swallowing involves tongue muscle strength with different volumes and textures, the measurement methods and statistical methods used are the same as those for measuring maximum tongue muscle strength.
Measured: up to 3 months
In the group of patients with dysphagia after stroke, explore the correlation between age and sex and the test items.
The investigator used the Iowa Oral Performance Instrument (IOPI) to measure tongue endurance in both with dysphagia after stroke and healthy adults. Tongue endurance was calculated as the duration of time that the participant could sustain 50% of their maximum tongue muscle strength. The duration was measured by the researchers using a stopwatch. The timing started when the pressure reached or exceeded the target pressure (indicated by a green light on the device's panel). However, the timing was stopped if there was a rapid decrease in pressure (when the tongue muscle strength remained between 40% and 50% of the maximum for at least 2 seconds, or if it dropped below 40% for more than 0.5 seconds).
Measured: up to 3 months
Explore the correlation between the severity of swallowing disorders (mild, moderate, severe) and the test items.
To examine the correlation between MASA scores and various observed variables in stroke patients with swallowing disorders, the statistical method of Pearson correlation coefficient can be used. This will help determine the degree of correlation between MASA scores and the different observed variables.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start17 Jan 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920993
- Sponsor's protocol ID
- 202211024RINC
- Status last verified
- Jan 2023
- First submitted
- 6 Mar 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Crow HC, Ship JA. Tongue strength and endurance in different aged individuals. J Gerontol A Biol Sci Med Sci. 1996 Sep;51(5):M247-50. doi: 10.1093/gerona/51a.5.m247.
PubMed 8808997Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Pownall S, Smith CJ. Impact of Dysphagia Assessment and Management on Risk of Stroke-Associated Pneumonia: A Systematic Review. Cerebrovasc Dis. 2018;46(3-4):99-107. doi: 10.1159/000492730. Epub 2018 Sep 10.
PubMed 30199856Hirota N, Konaka K, Ono T, Tamine K, Kondo J, Hori K, Yoshimuta Y, Maeda Y, Sakoda S, Naritomi H. Reduced tongue pressure against the hard palate on the paralyzed side during swallowing predicts Dysphagia in patients with acute stroke. Stroke. 2010 Dec;41(12):2982-4. doi: 10.1161/STROKEAHA.110.594960. Epub 2010 Nov 11.
PubMed 21071718
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performances and Differences in Tongue Function Between Healthy Adults and Dysphagia in Patients With Stroke in Taiwan
- ClinicalTrials.gov ID
- NCT05920993
- Acronym / sponsor ID
- 202211024RINC
- Conditions
- Cerebrovascular Accident, Healthy Adults
- Keywords
- tongue strength, healthy adults, tongue function, differences, correlations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
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:
- In a group of healthy adults, explore the correlation between age and sex and test items. (e.g. tongue strength, tongue endurance, the pressure of swallowing saliva, 3-ml water and fluids of varying textures and volumes).
- In the group of patients with stroke and dysphagia, explore the correlation between age and sex and the test items. (e.g. tongue strength, tongue endurance, the pressure of swallowing saliva)
- 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)
- Explore the correlation between the severity of swallowing disorders (mild, moderate, severe) and the test items. (e.g. 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | –Measures of tongue function were collected from two groups of individuals(healthy adults and stroke patients with dysphagia ). The items of measurement about healthy adults are the maximal tongue pressure, tongue endurance, and lingual swallowing pressures of saliva, 3-ml water, IDDSI 2, IDDSI3, and IDDSI 4 liquids. |
| Stroke patients with dysphagia | – | –The items of measurement about stroke patients with dysphagia are the maximal tongue pressure, tongue endurance, and lingual swallowing pressures of saliva. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was divided into two groups, patients with dysphagia after stroke and healthy adults. One group had normal oral motor function, and the other was identified as demonstrating signs of dysphagia caused by cerebrovascular disease. Stroke subjects with dysphagia will be referred by speech-language therapists at National Taiwan University Hospital. Healthy adult subjects will be surveyed by researcher who are age(±2) and sex-matched to stroke patients.
Key inclusion criteria (18 listed)
- Patients with dysphagia after stroke:
- Healthy adults:
Key exclusion criteria (1 listed)
- People with a history of neurodegenerative diseases, brain injuries, head and neck cancers, or those who have undergone head and neck surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Time frame: 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.
3 secondary outcomes
In a group of healthy adults, explore the correlation between age and sex and test items.
Time frame: up to 3 months
In the group of patients with dysphagia after stroke, explore the correlation between age and sex and the test items.
Time frame: up to 3 months
Explore the correlation between the severity of swallowing disorders (mild, moderate, severe) and the test items.
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 8808997Crow HC, Ship JA. Tongue strength and endurance in different aged individuals. J Gerontol A Biol Sci Med Sci. 1996 Sep;51(5):M247-50. doi: 10.1093/gerona/51a.5.m247.
- Background: PubMed 30199856Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Pownall S, Smith CJ. Impact of Dysphagia Assessment and Management on Risk of Stroke-Associated Pneumonia: A Systematic Review. Cerebrovasc Dis. 2018;46(3-4):99-107. doi: 10.1159/000492730. Epub 2018 Sep 10.
- Background: PubMed 21071718Hirota N, Konaka K, Ono T, Tamine K, Kondo J, Hori K, Yoshimuta Y, Maeda Y, Sakoda S, Naritomi H. Reduced tongue pressure against the hard palate on the paralyzed side during swallowing predicts Dysphagia in patients with acute stroke. Stroke. 2010 Dec;41(12):2982-4. doi: 10.1161/STROKEAHA.110.594960. Epub 2010 Nov 11.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebrovascular Accident
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Healthy Adults, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920993, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.