Clinical trial NCT06269718: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
dysphagia
tongue exercises
swallowing therapy
sonography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the change from baseline to time of swallowing muscle strength
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
measure: the change from baseline to time of Masster thickness
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
measure: the change from baseline to time of tongue muscles thickness
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
Secondary outcomes:
measure: the change from baseline to time of general muscle mass
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
measure: Measure the change in grip strength (by Jamar hand dynamometer)
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
measure: the change from baseline to time of swallowing functions
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
measure: the change from baseline to time of clinical nutrition status
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
measure: the change from baseline to time of swallowing functions 100 ml water test
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
measure: the change from baseline to time of quality of life
timeFrame: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: ChangGungMH
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yuchi Huang
role: STUDY_CHAIR
References: