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

Not Applicable
Completed
Conditions
Dysphagia
Stroke
Interventions
Behavioral: Exercise
Device: NMES (neuromuscular electrical stimulation)
Registration Number
NCT06321406
Lead Sponsor
Kayseri City Hospital
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control GroupExerciseExercises 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.
NMES(neuromuscular electrical stimulation) GroupNMES (neuromuscular electrical stimulation)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.
NMES(neuromuscular electrical stimulation) GroupExerciseOne 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.
Primary Outcome Measures
NameTimeMethod
Ultrasonographic measurementsat baseline, 4th week

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

Secondary Outcome Measures
NameTimeMethod
SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)at baseline, 4th week

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.

Functional Oral Intake Scale (FOIS)at baseline, 4th week

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.

Modified Mann Swallowing Ability Assessment Test (MMASA)at baseline, 4th week

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.

Swallowing Function Screening Test (EAT-10)at baseline, 4th week

It 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 week

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.

Trial Locations

Locations (1)

health sciences university Kayseri medicine faculty

🇹🇷

Kayseri, Turkey

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