StrokeNCT04728737
Changes of Swallowing Function and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Therapy and Neuromuscular Electrical Stimulation in Stroke Patients With Dysphagia
A study testing swallowing therapy, IOPI therapy and neuromuscular electrical stimulation (NMES) therapy in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
1. The inter-rater and intra-rater reliability of sonography. 2. To explore that sonography is a clinically practical tool for assessing the changes of oropharyngeal muscles mass. 3. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- swallowing therapy, IOPI therapy and neuromuscular electrical stimulation (NMES) therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Feb 2021to 16 May 2022
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The ages of participants should be from 40 to 80 years old.
- Normal people that are healthy and have no history of systemic diseases that are associated with swallowing difficulty.
- Patients with stroke that are diagnosed with oropharyngeal dysphagia (FOIS1-4).
- The duration since the onset of stroke should be 2-6 months.
- The ages of participants should be from 40 to 80 years old.
Who cannot join
- Any other history of systemic diseases that are associated with swallowing difficulty.
- Aged younger than 40 or older than 80 years old
- Intervention groups
- The stroke duration is less than 2 months or more than 6 months after stroke
- Aged younger than 40 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
Official title: The Changes of Swallowing Function and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Therapy and Neuromuscular Electrical Stimulation in Stroke Patients With Dysphagia
- The inter-rater and intra-rater reliability of sonography.
- To explore that sonography is a clinically practical tool for assessing the changes of oropharyngeal muscles mass.
- The Comparisons the differences in clinical swallowing function, general muscle mass, and muscle strength/ sonographic findings of oropharyngeal muscles among the stroke patients with dysphagia in different swallowing training programs.
- To investigate the associations among clinical swallowing function, general muscle mass, muscle strength and sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.
- The changes of clinical swallowing function, and muscle strength of oropharyngeal muscles in stroke patients with dysphagia after different swallowing training programs.
- The changes in sonographic findings of oropharyngeal muscles in stroke patients with dysphagia after different swallowing training programs.
- Effect of different swallowing therapies in clinical swallowing function, general muscle mass, and muscle strength/ sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.
- The associations between clinical swallowing function, oropharyngeal muscle strength, and sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.
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. Additionally, neuromuscular electrical stimulation (NMES) is also beneficial to manage PSD. 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 and neuromuscular electrical stimulation in PSD.
First, the investigators will enroll 20 normal people, whose ages should be from 40-80 years old, to verify the inter-rater and intra-rater reliability of sonography and use IOPI to assess maximal muscle strength and endurance of oropharyngeal muscles. Second, 40 stroke patients with different levels in 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. These stroke patients with dysphagia will be randomly allocated in two groups. the investigators will provide two interventions including combined simple and IOPI therapies(n=20), and combined swallowing therapy with NMES(n=20) for the 2 groups.
The investigators will investigate the differences of swallowing and tongue functions, oropharyngeal muscles on sonography in patients with PSD. The effects of the swallowing therapies in swallowing function, 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, neuromuscular electrical stimulation (NMES) therapy
- Keywords
- stroke, dysphagia, sonography, tongue exercises, swallowing therapy
- 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)
neuromuscular electrical stimulation (NMES) therapyOther
The neuromuscular electrical stimulation (NMES) therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the clinical swallowing disorders with for oropharyngeal muscles
(1 hour/session for 10 sessions)
| Study group | Role | What they receive |
|---|---|---|
| combined swallowing and IOPI group | Experimental | the patients will receive swallowing therapy and IOPI biofeedback exercise program Receives: Other: swallowing therapy; Other: IOPI therapy |
| combined swallowing and NMES group | Active comparator | the patients will receive swallowing therapy and neuromuscular electrical stimulation Receives: Other: swallowing therapy; Other: neuromuscular electrical stimulation (NMES) therapy |
| Normal group | No intervention | 20 normal people will receive sonography evaluations to verify the inter-rater and intra-rater reliability of sonography, and use IOPI to assess maximal muscle strength and endurance of oropharyngeal muscles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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), one week after three-week intervention, and four-week post intervention
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), one week after three-week intervention, and four-week post intervention
Interrater reliability of Sonography
To determine the index of inter-rater reliability of the thickness, the shear wave velocity (SWV) and echogenicity index (EI) of assessed muscles, the participants will be evaluated by one physician and then received second measurement by another physician within an hour interval. All images are acquired at the same time of day and obtained independently by each examiner without checking the first one to ensure blinding.
Measured: Baseline
Intrarater reliability of Sonography
To determine the index of intra-rater reliability of the thickness, the shear wave velocity (SWV) and echogenicity index (EI) of assessed muscles, the participants will be evaluated by one physician, and then receive second measurement by same physician within thirty minutes interval.
Measured: Baseline
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 maximal strength and endurance.
Iowa Oral Performance Instrument (IOPI, Medical LLC, Redmond, WA) is a standardize portable device that could be used to quantify the muscle strength of tongue and lips. It allows clinicians to set the peak level of resistance necessary to achieve optimal gains in strength as well as endurance while providing a visual feedback of performance to the patients.
Measured: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary outcomes (7)
the change from baseline to time of general muscle mass
measure bilateral calf circumferences
Measured: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Measure the change in grip strength (by Jamar hand dynamometer)
the change from baseline to time of general muscle mass
Measured: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Measure the change in gait speed (6-m walkway)
the change from baseline to time of general muscle mass
Measured: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
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), one week after three-week intervention, and four-week post intervention
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), one week after three-week intervention, and four-week post intervention
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 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.
Measured: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
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), one week after three-week intervention, and four-week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start2 Feb 2021
- Primary completion28 Mar 2022
- Study completion16 May 2022
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
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang Yuchi, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728737
- Sponsor's protocol ID
- CMRPG8L0491
- Status last verified
- May 2022
- First submitted
- 25 Jan 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Swallowing Function and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Therapy and Neuromuscular Electrical Stimulation in Stroke Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT04728737
- Acronym / sponsor ID
- CMRPG8L0491
- Conditions
- Stroke
- Keywords
- stroke, dysphagia, sonography, tongue exercises, swallowing therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 28 Jan 2021 (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 inter-rater and intra-rater reliability of sonography.
- To explore that sonography is a clinically practical tool for assessing the changes of oropharyngeal muscles mass.
- The Comparisons the differences in clinical swallowing function, general muscle mass, and muscle strength/ sonographic findings of oropharyngeal muscles among the stroke patients with dysphagia in different swallowing training programs.
- To investigate the associations among clinical swallowing function, general muscle mass, muscle strength and sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.
- The changes of clinical swallowing function, and muscle strength of oropharyngeal muscles in stroke patients with dysphagia after different swallowing training programs.
- The changes in sonographic findings of oropharyngeal muscles in stroke patients with dysphagia after different swallowing training programs.
- Effect of different swallowing therapies in clinical swallowing function, general muscle mass, and muscle strength/ sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.
- The associations between clinical swallowing function, oropharyngeal muscle strength, and sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.
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. Additionally, neuromuscular electrical stimulation (NMES) is also beneficial to manage PSD. 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 and neuromuscular electrical stimulation in PSD.
First, the investigators will enroll 20 normal people, whose ages should be from 40-80 years old, to verify the inter-rater and intra-rater reliability of sonography and use IOPI to assess maximal muscle strength and endurance of oropharyngeal muscles. Second, 40 stroke patients with different levels in 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. These stroke patients with dysphagia will be randomly allocated in two groups. the investigators will provide two interventions including combined simple and IOPI therapies(n=20), and combined swallowing therapy with NMES(n=20) for the 2 groups.
The investigators will investigate the differences of swallowing and tongue functions, oropharyngeal muscles on sonography in patients with PSD. The effects of the swallowing therapies in swallowing function, 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 (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combined swallowing and IOPI group | Experimental | Other: swallowing therapy, Other: IOPI therapythe patients will receive swallowing therapy and IOPI biofeedback exercise program |
| combined swallowing and NMES group | Active comparator | Other: swallowing therapy, Other: neuromuscular electrical stimulation (NMES) therapythe patients will receive swallowing therapy and neuromuscular electrical stimulation |
| Normal group | No intervention | –20 normal people will receive sonography evaluations to verify the inter-rater and intra-rater reliability of sonography, and use IOPI to assess maximal muscle strength and endurance of oropharyngeal muscles. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The ages of participants should be from 40 to 80 years old.
- Normal people that are healthy and have no history of systemic diseases that are associated with swallowing difficulty.
- Patients with stroke that are diagnosed with oropharyngeal dysphagia (FOIS1-4).
- The duration since the onset of stroke should be 2-6 months.
- The ages of participants should be from 40 to 80 years old.
Key exclusion criteria (7 listed)
- Any other history of systemic diseases that are associated with swallowing difficulty.
- Aged younger than 40 or older than 80 years old
- Intervention groups
- The stroke duration is less than 2 months or more than 6 months after stroke
- Aged younger than 40 or older than 80 years old
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 | combined swallowing and IOPI group, combined swallowing and NMES 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 | combined swallowing and IOPI group |
| neuromuscular electrical stimulation (NMES) therapyThe neuromuscular electrical stimulation (NMES) therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the clinical swallowing disorders with for oropharyngeal muscles (1 hour/session for 10 sessions) | Other | combined swallowing and NMES group |
Primary outcome
the change from baseline to time of Masster thickness
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
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), one week after three-week intervention, and four-week post intervention
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.
Interrater reliability of Sonography
Time frame: Baseline
To determine the index of inter-rater reliability of the thickness, the shear wave velocity (SWV) and echogenicity index (EI) of assessed muscles, the participants will be evaluated by one physician and then received second measurement by another physician within an hour interval. All images are acquired at the same time of day and obtained independently by each examiner without checking the first one to ensure blinding.
Intrarater reliability of Sonography
Time frame: Baseline
To determine the index of intra-rater reliability of the thickness, the shear wave velocity (SWV) and echogenicity index (EI) of assessed muscles, the participants will be evaluated by one physician, and then receive second measurement by same physician within thirty minutes interval.
the change from baseline to time of swallowing muscle strength
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
the evaluation would be executed by an experienced speech and language therapist. The target muscles include tongue and lip maximal strength and endurance. Iowa Oral Performance Instrument (IOPI, Medical LLC, Redmond, WA) is a standardize portable device that could be used to quantify the muscle strength of tongue and lips. It allows clinicians to set the peak level of resistance necessary to achieve optimal gains in strength as well as endurance while providing a visual feedback of performance to the patients.
7 secondary outcomes
the change from baseline to time of general muscle mass
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Measure the change in grip strength (by Jamar hand dynamometer)
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Measure the change in gait speed (6-m walkway)
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
the change from baseline to time of quality of life
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
the change from baseline to time of swallowing functions 100 ml water test
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
the change from baseline to time of swallowing functions
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
the change from baseline to time of clinical nutrition status
Time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention
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 26 May 2022.
- 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.
Huang Yuchi 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, IOPI therapy and neuromuscular electrical stimulation (NMES) 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 5 inclusion and 7 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 26 May 2022. 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 Masster thickness (time frame: Baseline (before intervention), one week after three-week intervention, and four-week post intervention). The study lists 5 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 26 May 2022.