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

June 3, 2024 updated by: Havva Talay Çalış, Kayseri City Hospital

Effect of Superficial Neuromuscular Stimulation on Ultrasonographic Findings of Oropharyngeal Swallowing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38080
        • health sciences university Kayseri medicine faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control 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.
Behavioral: Exercise
Traditional Conservative swallowing treatment
Active Comparator: NMES(neuromuscular electrical stimulation) 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 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.
Behavioral: Exercise
Traditional Conservative swallowing treatment
Device: NMES (neuromuscular electrical stimulation)
With this application, swallowing muscles are stimulated and muscle strength increases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at baseline, 4th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline, 4th week
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.
at baseline, 4th week
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.
at baseline, 4th week
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.
at baseline, 4th week
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.
at baseline, 4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri City Hospital

Investigators

  • Principal Investigator: Neslihan YAĞMUR GÖZ, Kayseri City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 3, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KayseriCHdysphagia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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