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

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. 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.
3. 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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: swallowing therapy; Other: IOPI therapy

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuchi MD Huang, MD; Phone Number: 6286 +866-7-7317123; Email: hyuchi@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Recruiting
    • ChangGungMH
    • Contact: Yuchi Huang, MD; Phone Number: 6286 886-7-7317123; Email: hyuchi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The IOPI group; tongue muscle strengthening and endurance exercises by using 15-min IOPI biofeedback program. The biofeedback will be 50%-60% of maximal strength	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; Other: 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)
Active Comparator: The general swallowing group; oral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change from baseline to time of general muscle mass	measure bilateral calf circumferences	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	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.	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.	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	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.	baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Yuchi Huang, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: stroke; sonography; dysphagia; swallowing therapy; tongue exercises
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: CMRPG8N0471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No