An interventional study of NMES (neuromuscular electrical stimulation) and Exercise in Dysphagia and Stroke, sponsored by Kayseri City Hospital. Completed at 1 site in Turkey. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Kayseri City Hospital · Not applicable, Interventional, and Treatment
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.
A randomized, prospective, controlled study will include 10 patients with post-stroke dysphagia. Groups will be randomized into 2 groups.
Patients' dysphagia scales, quality of life survey and ultrasonography measurements will be performed before and after treatment.
Tests to be applied
Clinic Responsible for Research: Physical Therapy and Rehabilitation Clinic of Kayseri City Hospital
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
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Exclusion Criteria:
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.
Behavioral: Exercise
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 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.
Device: NMES (neuromuscular electrical stimulation) · Behavioral: Exercise
With this application, swallowing muscles are stimulated and muscle strength increases.
Traditional Conservative swallowing treatment
Ultrasonographic measurements
Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)
Time frame: at baseline, 4th week
Functional Oral Intake Scale (FOIS)
Functional 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.
Time frame: at baseline, 4th week
Swallowing Function Screening Test (EAT-10)
It is a useful questionnaire consisting of 10 questions with Turkish validity and reliability and which patients can easily fill out.
Time frame: at baseline, 4th week
GUSS (Gagging Swallowing Screening Test)
GUSS 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.
Time frame: at baseline, 4th week
Modified Mann Swallowing Ability Assessment Test (MMASA)
It 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.
Time frame: at baseline, 4th week
SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)
Swallow 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.
Time frame: at baseline, 4th week
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Kayseri City Hospital