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NCT Number: NCT06321406

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

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.

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Key information

Conditions

Dysphagia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

health sciences university Kayseri medicine faculty

Kayseri, 38080, Turkey (Türkiye)

About this study

A randomized, prospective, controlled study will include 10 patients with post-stroke dysphagia. Groups will be randomized into 2 groups.

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NMES (neuromuscular electrical stimulation)

Device

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

Exercise

Behavioral

Traditional Conservative swallowing treatment

Primary outcomes

  1. 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

  1. Functional Oral Intake Scale (FOIS)

    Time frame: 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.

  2. Swallowing Function Screening Test (EAT-10)

    Time frame: 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.

  3. GUSS (Gagging Swallowing Screening Test)

    Time frame: 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.

  4. Modified Mann Swallowing Ability Assessment Test (MMASA)

    Time frame: 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.

  5. SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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