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Effect of Superficial Neuromuscular Stimulation in Post-stroke Dysphagic Patients.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06321406
Enrollment
10
Registered
2024-03-20
Start date
2024-04-15
Completion date
2024-06-03
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Stroke

Keywords

dysphagia, post-stroke dysphagia, rehabilitation, ultrasonography

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

Interventions

DEVICENMES (neuromuscular electrical stimulation)

With this application, swallowing muscles are stimulated and muscle strength increases.

BEHAVIORALExercise

Traditional Conservative swallowing treatment

Sponsors

Kayseri City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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 * Epilepsy

Design outcomes

Primary

MeasureTime frameDescription
Ultrasonographic measurementsat baseline, 4th weekMeasurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)

Secondary

MeasureTime frameDescription
Functional Oral Intake Scale (FOIS)at baseline, 4th weekFunctional Oral Intake Scale (FOIS) is an ordinal scale with validity and reliability designed to evaluate the current status and functional change in oral intake of patients with neurogenic dysphagia. This scale consists of 7 items. Items 1 to 3 are related to inability to feed orally, items 4 to 7 are related to oral feeding.
Swallowing Function Screening Test (EAT-10)at baseline, 4th weekIt is a useful questionnaire consisting of 10 questions with Turkish validity and reliability and which patients can easily fill out.
GUSS (Gagging Swallowing Screening Test)at baseline, 4th weekGUSS is one of the approved swallowing screening tests in acute stroke patients. It provides dietary recommendations as well as screening for aspiration risk. It consists of two main parts; In the first part, conditions such as alertness, salivation, and cough are evaluated as an indirect swallowing test. In the second part, the direct swallowing test, swallowing trials are performed with three different consistencies: semi-solid, liquid and solid. 5 points are achieved in each subgroup. Scores between 0 and 9 are considered as severe dysphagia and special diet and videofluoroscopic examination are recommended. 10-14 points are considered moderate dysphagia, 5-19 points are considered mild dysphagia, and 20 points are considered normal.
Modified Mann Swallowing Ability Assessment Test (MMASA)at baseline, 4th weekIt is a bedside test that evaluates parameters such as alertness, cooperation, respiration, expressive speech, auditory perception, dysarthria, salivation, tongue movement, tongue strength, gagging, cough reflex and palate movement. The highest score is 100. It is recommended that patients who score 94 or below as a result of the evaluation should not be fed orally and should be referred to a speech-language pathologist.
SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)at baseline, 4th weekSwallow Quality of Life Questionnaire (SWAL-QOL) is one of the most widely known patient based and dysphagia specific item questionnaire. It is a valid and reliable scale in the evaluation of dysphagia.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026