Changes of Swallowing Function and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Therapy and Neuromuscular Electrical Stimulation in Stroke Patients With Dysphagia
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
swallowing therapy
IOPI therapy
neuromuscular electrical stimulation (NMES) therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, dysphagia, sonography, tongue exercises, swallowing therapy
Eligibility Criteria
Normal group
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Any other history of systemic diseases that are associated with swallowing difficulty.
- Aged younger than 40 or older than 80 years old
Intervention groups
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Kaohsiung Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
combined swallowing and IOPI group
combined swallowing and NMES group
Normal group
Arm Description
the patients will receive swallowing therapy and IOPI biofeedback exercise program
the patients will receive swallowing therapy and neuromuscular electrical stimulation
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
the change from baseline to time of general muscle mass
measure bilateral calf circumferences
Measure the change in grip strength (by Jamar hand dynamometer)
the change from baseline to time of general muscle mass
Measure the change in gait speed (6-m walkway)
the change from baseline to time of general muscle mass
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.
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.
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.
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.
Full Information
NCT ID
NCT04728737
First Posted
January 25, 2021
Last Updated
May 24, 2022
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04728737
Brief Title
Changes of Swallowing Function and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Therapy and Neuromuscular Electrical Stimulation in Stroke Patients With Dysphagia
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, dysphagia, sonography, tongue exercises, swallowing therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combined swallowing and IOPI group
Arm Type
Experimental
Arm Description
the patients will receive swallowing therapy and IOPI biofeedback exercise program
Arm Title
combined swallowing and NMES group
Arm Type
Active Comparator
Arm Description
the patients will receive swallowing therapy and neuromuscular electrical stimulation
Arm Title
Normal group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
swallowing therapy
Intervention Description
oral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during intervention
Intervention Type
Other
Intervention Name(s)
IOPI therapy
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
neuromuscular electrical stimulation (NMES) therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
the change from baseline to time of Masster thickness
Description
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.
Time Frame
Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Title
the change from baseline to time of tongue muscles thickness
Description
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.
Time Frame
Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Title
Interrater reliability of Sonography
Description
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.
Time Frame
Baseline
Title
Intrarater reliability of Sonography
Description
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.
Time Frame
Baseline
Title
the change from baseline to time of swallowing muscle strength
Description
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.
Time Frame
Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary Outcome Measure Information:
Title
the change from baseline to time of general muscle mass
Description
measure bilateral calf circumferences
Time Frame
Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Title
Measure the change in grip strength (by Jamar hand dynamometer)
Description
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
Title
Measure the change in gait speed (6-m walkway)
Description
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
Title
the change from baseline to time of quality of life
Description
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.
Time Frame
Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Title
the change from baseline to time of swallowing functions 100 ml water test
Description
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.
Time Frame
Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Title
the change from baseline to time of swallowing functions
Description
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.
Time Frame
Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Title
the change from baseline to time of clinical nutrition status
Description
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.
Time Frame
Baseline (before intervention), one week after three-week intervention, and four-week post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Normal group
Inclusion Criteria:
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.
Exclusion Criteria:
Any other history of systemic diseases that are associated with swallowing difficulty.
Aged younger than 40 or older than 80 years old
Intervention groups
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang Yuchi
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Changes of Swallowing Function and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Therapy and Neuromuscular Electrical Stimulation in Stroke Patients With Dysphagia
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