Changes of Swallowing Function and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Therapy and Neuromuscular Electrical Stimulation in Stroke Patients With Dysphagia

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728737
• Other study ID #: CMRPG8L0491
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: May 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

4. To investigate the associations among clinical swallowing function, general muscle mass, muscle strength and sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.

5. The changes of clinical swallowing function, and muscle strength of oropharyngeal muscles in stroke patients with dysphagia after different swallowing training programs.

6. The changes in sonographic findings of oropharyngeal muscles in stroke patients with dysphagia after different swallowing training programs.

7. 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.

8. The associations between clinical swallowing function, oropharyngeal muscle strength, and sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 16, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Stroke

Intervention

Other:
• swallowing therapy
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 therapy
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) therapy
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)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Primary	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.	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary	the change from baseline to time of general muscle mass	measure bilateral calf circumferences	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary	Measure the change in grip strength (by Jamar hand dynamometer)	the change from baseline to time of general muscle mass	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary	Measure the change in gait speed (6-m walkway)	the change from baseline to time of general muscle mass	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary	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.	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary	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.	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary	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.	Baseline (before intervention), one week after three-week intervention, and four-week post intervention
Secondary	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.	Baseline (before intervention), one week after three-week intervention, and four-week post intervention