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

NCT06269718 | Recruiting

• 1 other identifier: CMRPG8N0471
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are:

1. 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. 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. 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.

Conditions

Stroke

Keywords

stroke; dysphagia; tongue exercises; swallowing therapy; sonography

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

• Measure the change in grip strength (by Jamar hand dynamometer)

  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

  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

  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

  baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments

Study Arms (2)

The IOPI group

EXPERIMENTAL

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; Other: IOPI therapy

The general swallowing group

ACTIVE COMPARATOR

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

Interventions

swallowing therapy OTHER

oral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during intervention

The IOPI group; The general swallowing group

IOPI therapy OTHER

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)

The IOPI group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

ChangGungMH

Kaohsiung City, 833, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Yuchi Huang

  Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Yuchi MD Huang, MD

CONTACT

+866-7-7317123; hyuchi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: December 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)