StrokeNCT06269718
The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia
A study testing swallowing therapy and IOPI therapy in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aims of this study are: 1. Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function 2. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- swallowing therapy and IOPI therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2023to 31 Jul 2024
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke patients with hemiplegia that are diagnosed with or without dysphagia (FOIS1-7)
- The duration since the onset of stroke should be within 6 months.
- The ages of participants should be from 18 to 80 years old.
Who cannot join
- The stroke duration is more than 6 months after stroke
- Aged younger than 18 or older than 80 years old
- Any cognitive deficit that leads to communicative difficulty.
- Any other history of systemic diseases that are associated with swallowing difficulty.
Trial locations and contacts
1 site in 1 country.
About this study
The aims of this study are:
- Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function
- To explore the changes in clinical mastication and swallowing functions, tongue pressure and oropharyngeal muscle thickness in patients with dysphagia and stroke after swallowing treatment and neuromuscular electrical stimulation training.
- To explore the correlation between clinical mastication and swallowing functions, tongue pressure, oropharyngeal muscle thickness and ultrasound imaging results in patients with dysphagia and stroke.
Read the detailed description
After acute stroke, 25∼45% of patients show difficulties in swallowing, which is associated with a high risk of pneumonia, malnutrition, and mortality. In addition to traditional swallowing therapies for post-stroke dysphagia (PSD), the Iowa Oral Performance Instrument (IOPI) is used to provide tongue exercise program which improving swallowing function. In rehabilitation unit, ultrasound is a convenient tool and is more widely used in investigating oropharyngeal muscles mass and quality in PSD. Therefore, the investigators hope to assess the effects on swallowing function and oropharyngeal muscle mass on sonography after IOPI swallowing training in PSD. In this study, 60 stroke patients with or without dysphagia will be enrolled. Each patient will receive clinical assessments of swallowing and tongue functions, general and oropharyngeal muscles mass and quality by sonography, and life quality. Furthermore, the investigators'll enrolled 50 stroke patients with dysphagia and they will be randomly allocated in two groups. the investigators will provide two interventions including general swallowing therapy, and combined simple and IOPI therapies. First, the investigators will investigate the differences of swallowing and tongue functions, oropharyngeal muscles on sonography in patients with or without PSD. The effects of the swallowing therapies in masticatory and swallowing function, tongue pressure, oropharyngeal muscle mass, and life quality will be explored in PSD by using different swallowing therapies. The investigators will find out the most effective swallowing therapy from these 2 interventions for PSD. Furthermore, the investigators could explore that sonography is a clinically practical tool for assessing oropharyngeal muscles mass and quality in PSD.
- Conditions
- Stroke
- Being tested
- swallowing therapy, IOPI therapy
- Keywords
- stroke, dysphagia, tongue exercises, swallowing therapy, sonography
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swallowing therapyOther
oral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during intervention
IOPI therapyOther
tongue muscle strengthening and endurance exercises by using 15-min IOPI biofeedback program. The biofeedback will be 50%-60% of maximal strength. (total 1 hour/session for 10 sessions)
| Study group | Role | What they receive |
|---|---|---|
| The IOPI group | Experimental | tongue muscle strengthening and endurance exercises by using 15-min IOPI biofeedback program. The biofeedback will be 50%-60% of maximal strength Receives: Other: swallowing therapy; Other: IOPI therapy |
| The general swallowing group | Active comparator | oral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during intervention Receives: Other: swallowing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline to time of swallowing muscle strength
the evaluation would be executed by an experienced speech and language therapist. The target muscles include tongue and lip strength and endurance.
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of Masster thickness
The measurement of masseter thickness would be placed at the most prominent area of the masseter muscle in longitudinal and transverse planes.
The measurements will be taken during relaxation and maximal jaw clenching (2 conditions). The measurements were performed 3 times, and the mean value would be adapted for further analysis.
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of tongue muscles thickness
For the tongue muscles, the probe will be placed on the point of the lower chin surface be performed at the maximal cross-section area of the muscles in both longitudinal and transverse planes. The measurements were performed 3 times, and expressed as the mean.
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
Secondary outcomes (6)
the change from baseline to time of general muscle mass
measure bilateral calf circumferences
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
Measure the change in grip strength (by Jamar hand dynamometer)
the change from baseline to time of general muscle mass
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of swallowing functions
Functional Oral Intake Scale (FOIS) score is a simple assessing scale to quickly identify the swallowing functions. The score ranges from 1 to 7.
The score of this scale is defined as follows:
1, dependency of tube without oral intake ; 2, dependency of tube with inconsistent oral intake; 3, dependency of tube as a supplement with consistent oral intake; 4, total oral intake of a single consistency; 5, total oral intake with specific preparation for multiple consistency; 6, total oral intake without any specific preparation, but avoid specific liquids or food; 7, total oral intake without any restrictions. Higher scores mean a better outcome.
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of clinical nutrition status
Mini-nutritional assessment short form (MNA) is a screening form to identify patients who are malnourished or at risk of malnutrition, which allows clinicians to intervene earlier to provide adequate nutritional support, prevent further deterioration, and improve patient outcomes.
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of swallowing functions 100 ml water test
100 ml water test has been used as a screening tool for patients with stroke who are at risk of aspiration. This test could also be used to monitor the complete swallowing performances
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of quality of life
A self-reported questionnaire, the Dysphagia Handicap Index, would be used to evaluate the quality of life. Dysphagia Handicap Index is for patients with dysphagia that provide information regarding the success or failure of swallowing therapy.
Measured: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuchi Huang, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269718
- Sponsor's protocol ID
- CMRPG8N0471
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT06269718
- Acronym / sponsor ID
- CMRPG8N0471
- Conditions
- Stroke
- Keywords
- stroke, dysphagia, tongue exercises, swallowing therapy, sonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Feb 2024 (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.
The aims of this study are:
- Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function
- To explore the changes in clinical mastication and swallowing functions, tongue pressure and oropharyngeal muscle thickness in patients with dysphagia and stroke after swallowing treatment and neuromuscular electrical stimulation training.
- To explore the correlation between clinical mastication and swallowing functions, tongue pressure, oropharyngeal muscle thickness and ultrasound imaging results in patients with dysphagia and stroke.
Detailed description
After acute stroke, 25∼45% of patients show difficulties in swallowing, which is associated with a high risk of pneumonia, malnutrition, and mortality. In addition to traditional swallowing therapies for post-stroke dysphagia (PSD), the Iowa Oral Performance Instrument (IOPI) is used to provide tongue exercise program which improving swallowing function. In rehabilitation unit, ultrasound is a convenient tool and is more widely used in investigating oropharyngeal muscles mass and quality in PSD. Therefore, the investigators hope to assess the effects on swallowing function and oropharyngeal muscle mass on sonography after IOPI swallowing training in PSD. In this study, 60 stroke patients with or without dysphagia will be enrolled. Each patient will receive clinical assessments of swallowing and tongue functions, general and oropharyngeal muscles mass and quality by sonography, and life quality. Furthermore, the investigators'll enrolled 50 stroke patients with dysphagia and they will be randomly allocated in two groups. the investigators will provide two interventions including general swallowing therapy, and combined simple and IOPI therapies. First, the investigators will investigate the differences of swallowing and tongue functions, oropharyngeal muscles on sonography in patients with or without PSD. The effects of the swallowing therapies in masticatory and swallowing function, tongue pressure, oropharyngeal muscle mass, and life quality will be explored in PSD by using different swallowing therapies. The investigators will find out the most effective swallowing therapy from these 2 interventions for PSD. Furthermore, the investigators could explore that sonography is a clinically practical tool for assessing oropharyngeal muscles mass and quality in PSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The IOPI group | Experimental | Other: swallowing therapy, Other: IOPI therapytongue muscle strengthening and endurance exercises by using 15-min IOPI biofeedback program. The biofeedback will be 50%-60% of maximal strength |
| The general swallowing group | Active comparator | Other: swallowing therapyoral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke patients with hemiplegia that are diagnosed with or without dysphagia (FOIS1-7)
- The duration since the onset of stroke should be within 6 months.
- The ages of participants should be from 18 to 80 years old.
Key exclusion criteria (4 listed)
- The stroke duration is more than 6 months after stroke
- Aged younger than 18 or older than 80 years old
- Any cognitive deficit that leads to communicative difficulty.
- Any other history of systemic diseases that are associated with swallowing difficulty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| swallowing therapyoral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during intervention | Other | The IOPI group, The general swallowing group |
| IOPI therapytongue muscle strengthening and endurance exercises by using 15-min IOPI biofeedback program. The biofeedback will be 50%-60% of maximal strength. (total 1 hour/session for 10 sessions) | Other | The IOPI group |
Primary outcome
the change from baseline to time of swallowing muscle strength
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the evaluation would be executed by an experienced speech and language therapist. The target muscles include tongue and lip strength and endurance.
the change from baseline to time of Masster thickness
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
The measurement of masseter thickness would be placed at the most prominent area of the masseter muscle in longitudinal and transverse planes. The measurements will be taken during relaxation and maximal jaw clenching (2 conditions). The measurements were performed 3 times, and the mean value would be adapted for further analysis.
the change from baseline to time of tongue muscles thickness
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
For the tongue muscles, the probe will be placed on the point of the lower chin surface be performed at the maximal cross-section area of the muscles in both longitudinal and transverse planes. The measurements were performed 3 times, and expressed as the mean.
6 secondary outcomes
the change from baseline to time of general muscle mass
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
Measure the change in grip strength (by Jamar hand dynamometer)
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of swallowing functions
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of clinical nutrition status
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of swallowing functions 100 ml water test
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the change from baseline to time of quality of life
Time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Yuchi Huang study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing swallowing therapy and IOPI therapy in people with Stroke, run by Chang Gung Memorial 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Nov 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the change from baseline to time of swallowing muscle strength (time frame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.