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Clinical Trials/NCT06321406
NCT06321406
Completed
Not Applicable

Effect of Superficial Neuromuscular Stimulation on Ultrasonographic Findings of Oropharyngeal Swallowing in Post-stroke Dysphagic Patients.

Kayseri City Hospital1 site in 1 country10 target enrollmentApril 15, 2024
ConditionsDysphagiaStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysphagia
Sponsor
Kayseri City Hospital
Enrollment
10
Locations
1
Primary Endpoint
Ultrasonographic measurements
Status
Completed
Last Updated
last year

Overview

Brief Summary

Swallowing disorder in stroke patients is a significant cause of morbidity and mortality as it can cause aspiration pneumonia. Electrical stimulation has proven to be effective in post-stroke dysphagic patients.10 patients who have symptoms of post-stroke dysphagia, meet the inclusion criteria and volunteer to participate will be included in the study. Included patients will be randomized into 2 groups. The exercise program will be applied to both groups as a home program for 4 weeks.

Detailed Description

A randomized, prospective, controlled study will include 10 patients with post-stroke dysphagia. Groups will be randomized into 2 groups. 1. st group; One electrode will be connected to the suprahyoid region and the other electrode will be connected between the thyroid and hyoid cartilages. Superficial neuromuscular stimulation will be applied by the physiotherapist at 80 Hz, 0-25 µA (microampere) current range for 20 minutes, for 5 days for the patient, for a total of 4 weeks. At the same time, each patient will be taught the exercises included in traditional swallowing treatment and will be advised to practice them for 30 minutes every day. 2. nd group; Exercises such as progressively resistant oral-facial, lingual, laryngeal exercises, tongue strengthening exercises, effortful swallowing maneuver, thermal/tactile stimulation to oropharyngeal muscles, Masako maneuver, Mendelson maneuver, Shaker maneuver, which are included in traditional swallowing treatment, will be taught and practiced for 30 minutes will be recommended for one month. Patients' dysphagia scales, quality of life survey and ultrasonography measurements will be performed before and after treatment. Tests to be applied * Functional Oral Intake Scale (FOAS) * Swallowing Function Screening Test (EAT-10) * GUSS (Gagging Swallowing Screening Test) * Modified Mann Swallowing Ability Assessment Test (MMASA) * SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire), * Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures) Clinic Responsible for Research: Physical Therapy and Rehabilitation Clinic of Kayseri City Hospital

Registry
clinicaltrials.gov
Start Date
April 15, 2024
End Date
June 3, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kayseri City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Havva Talay Çalış

Professor Doctor

Kayseri City Hospital

Eligibility Criteria

Inclusion Criteria

  • Male and female patients over 40 years of age with post-stroke dysphagia
  • Patients with Functional Oral Intake Scale (FOAS) 1-6

Exclusion Criteria

  • Patients younger than 40 years old
  • Dementia, impaired consciousness or hypoesthetic /anesthetic patients
  • Patients with low body mass
  • Patients with pacemakers and severe heart disease
  • Severe hypertension and hypotension
  • Thrombosis or thrombophlebitis
  • Pregnancy

Outcomes

Primary Outcomes

Ultrasonographic measurements

Time Frame: at baseline, 4th week

Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)

Secondary Outcomes

  • SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)(at baseline, 4th week)
  • Functional Oral Intake Scale (FOIS)(at baseline, 4th week)
  • Modified Mann Swallowing Ability Assessment Test (MMASA)(at baseline, 4th week)
  • Swallowing Function Screening Test (EAT-10)(at baseline, 4th week)
  • GUSS (Gagging Swallowing Screening Test)(at baseline, 4th week)

Study Sites (1)

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