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

NCT04728737 | Completed DMC

• 1 other identifier: CMRPG8L0491
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The inter-rater and intra-rater reliability of sonography.
2. 2.To explore that sonography is a clinically practical tool for assessing the changes of oropharyngeal muscles mass.
3. 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. 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. 5.The changes of clinical swallowing function, and muscle strength of oropharyngeal muscles in stroke patients with dysphagia after different swallowing training programs.
6. 6.The changes in sonographic findings of oropharyngeal muscles in stroke patients with dysphagia after different swallowing training programs.
7. 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. 8.The associations between clinical swallowing function, oropharyngeal muscle strength, and sonographic findings of oropharyngeal muscles in stroke patients with dysphagia.

Conditions

Stroke

Keywords

stroke; dysphagia; sonography; tongue exercises; swallowing therapy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• the change from baseline to time of general muscle mass

  Baseline (before intervention), one week after three-week intervention, and four-week post intervention

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

  Baseline (before intervention), one week after three-week intervention, and four-week post intervention

• Measure the change in gait speed (6-m walkway)

  Baseline (before intervention), one week after three-week intervention, and four-week post intervention

• the change from baseline to time of quality of life

  Baseline (before intervention), one week after three-week intervention, and four-week post intervention

• the change from baseline to time of swallowing functions 100 ml water test

  Baseline (before intervention), one week after three-week intervention, and four-week post intervention

Study Arms (3)

combined swallowing and IOPI group

EXPERIMENTAL

the patients will receive swallowing therapy and IOPI biofeedback exercise program

Other: swallowing therapy; Other: IOPI therapy

combined swallowing and NMES group

ACTIVE COMPARATOR

the patients will receive swallowing therapy and neuromuscular electrical stimulation

Other: swallowing therapy; Other: neuromuscular electrical stimulation (NMES) therapy

Normal group

NO INTERVENTION

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.

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

combined swallowing and IOPI group; combined swallowing and NMES 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)

combined swallowing and IOPI group

neuromuscular electrical stimulation (NMES) therapy OTHER

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)

combined swallowing and NMES group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any other history of systemic diseases that are associated with swallowing difficulty.
• Aged younger than 40 or older than 80 years old
• Intervention groups
• 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.
• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Interventions

Therapeutics

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

• Huang Yuchi

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: February 2, 2021
• Primary Completion: March 28, 2022
• Study Completion: May 16, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)