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The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia

Primary Purpose

Stroke, Swallowing Disorder, Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Procedure: Traditional Dysphagia Therapy (TDT)
Procedure: Neuromuscular Electrical Stimulation with TDT
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, swallowing disorder, dysphagia, stroke rehabilitation, neuromuscular electrical stimulation, traditional dysphagia therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • After the first week after a stroke, detecting dysphagia by using bedside water assessment test
  • Lesion location is shown by MRI or CT
  • Unsupported sitting balance
  • The score of Mini-mental state examination test (MMSE) 20 and above
  • Over 18 years old

Exclusion Criteria:

  • Global aphasia or cognitive disorders that may affect the understanding of the instructions
  • Patients with major medical problems that may affect participation
  • Tracheostomy presence
  • Previous neck surgery
  • To have received radiotherapy in the head or neck area
  • Presence of a cardiac pacemaker or a history of epilepsy

Sites / Locations

  • Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromuscular Electrical Stimulation (NMES) with TDT

Traditional Dysphagia Therapy (TDT)

Arm Description

Outcomes

Primary Outcome Measures

Change in Functional Oral Intake Scale (FOIS)
Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.

Secondary Outcome Measures

Change in Eating Assessment Tool-10 (EAT-10) Score
Eating Assessment Tool-10 (EAT-10) is used to assess participants' dysphagia symptoms, symptom severity, and risk of oropharyngeal dysphagia. This scale is a scale of 10 questions that the patient himself answers, which questions the symptoms of dysphagia. The answer points for each question range from 0 (no problem) to 4 (serious problem). If EAT-10 score is ≥3, it is considered as "risk of oropharyngeal dysphagia". It is a useful tool to evaluate the severity of dysphagia symptom in the clinic, to monitor the progression and effectiveness of the disease.
Change in Swallowing-related Quality of Life (SWAL-QOL) Score
Swallowing-related quality of life scale (SWAL-QOL) is used to evaluate the effect of swallowing disorders on quality of life. It was created to evaluate the quality of life of patients with oropharyngeal dysphagia. It includes a total of 44 questions under eating disorder, eating time, eating desire, food selection, communication, anxiety, mental health, social functionality, fatigue, and sleep subgroups. Each question is evaluated with a score ranging from 1 (worst) to 5 (best). The subgroup scores of the scale and the total score of the scale can be used to assess the change in patients.
Change in Visual Analog Scale (VAS)
Patients' difficulty in swallowing will be questioned using the Visual Analogue Scale (VAS). On a scale of ten centimeters, patients will be asked to mark the appropriate level of dysphagia 0: No dysphagia, 10: Very severe dysphagia.
Change in Laryngostroboscopy Examination
In the Istanbul Faculty of Medicine Otorhinolaryngology Diseases Clinic, evaluations will be made by the Ear Nose Throat Specialist. Whether there is vocal cord paresis and paralysis and whether glottic patency is evaluated in the laryngostroboscopic examination.
Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Fiberoptic endoscopic swallowing assessment will be performed by the otolaryngologist doctor before and immediately after the treatment. In the fiberoptic endoscopic swallowing assessment, the condition of the patient according to the penetration aspiration scale will be checked. Grade 1 represents the best and grade 7 the worst on the penetration aspiration scale.
Change in Voice-Related Quality of Life (V-RQOL) Score
This ten-item scale is a scale designed for adult populations with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The answer points for each question range from 1 (few problems) to 5 (serious problems). A total score change on this scale will be used to evaluate patients.

Full Information

First Posted
May 16, 2020
Last Updated
August 20, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04421937
Brief Title
The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia
Official Title
The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Swallowing Disorder, Dysphagia, Stroke, Complication, Cerebrovascular Accident
Keywords
stroke, swallowing disorder, dysphagia, stroke rehabilitation, neuromuscular electrical stimulation, traditional dysphagia therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Electrical Stimulation (NMES) with TDT
Arm Type
Experimental
Arm Title
Traditional Dysphagia Therapy (TDT)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Procedure: Traditional Dysphagia Therapy (TDT)
Intervention Description
Traditional dysphagia therapy includes diet modification training, teaching postural compensatory methods, training of oral motor control exercises and tongue root exercises, training of swallowing maneuvers, and practice of chin-resistance exercise, which is the exercise of opening the upper esophageal sphincter. Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.
Intervention Type
Device
Intervention Name(s)
Procedure: Neuromuscular Electrical Stimulation with TDT
Intervention Description
The skin to be treated will be cleaned and dried. NMES will be implemented with signals received from two channels. In the first channel, the upper electrodes will be placed horizontally just above the hyoid bone. This is the place where the cupping is felt when the finger is pressed right under the chin. In the second channel, the lower electrodes will be placed horizontally, just above the thyrohyoid muscle. This is the place where you can feel a cupping when pressed with your finger, on both sides of the apple in the larynx. The device will be set to start at the lowest power, with very short pulses of approximately 700 microseconds, at intervals of 1 second. The power will be gradually increased according to the device and the power that the patient feels vibration will be stopped. The power to be applied will not exceed 25 milliamps. NMES application and Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.
Primary Outcome Measure Information:
Title
Change in Functional Oral Intake Scale (FOIS)
Description
Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.
Time Frame
before intervention, immediately after intervention, 3 months after the intervention
Secondary Outcome Measure Information:
Title
Change in Eating Assessment Tool-10 (EAT-10) Score
Description
Eating Assessment Tool-10 (EAT-10) is used to assess participants' dysphagia symptoms, symptom severity, and risk of oropharyngeal dysphagia. This scale is a scale of 10 questions that the patient himself answers, which questions the symptoms of dysphagia. The answer points for each question range from 0 (no problem) to 4 (serious problem). If EAT-10 score is ≥3, it is considered as "risk of oropharyngeal dysphagia". It is a useful tool to evaluate the severity of dysphagia symptom in the clinic, to monitor the progression and effectiveness of the disease.
Time Frame
before intervention, immediately after intervention, 3 months after the intervention
Title
Change in Swallowing-related Quality of Life (SWAL-QOL) Score
Description
Swallowing-related quality of life scale (SWAL-QOL) is used to evaluate the effect of swallowing disorders on quality of life. It was created to evaluate the quality of life of patients with oropharyngeal dysphagia. It includes a total of 44 questions under eating disorder, eating time, eating desire, food selection, communication, anxiety, mental health, social functionality, fatigue, and sleep subgroups. Each question is evaluated with a score ranging from 1 (worst) to 5 (best). The subgroup scores of the scale and the total score of the scale can be used to assess the change in patients.
Time Frame
before intervention, immediately after intervention, 3 months after the intervention
Title
Change in Visual Analog Scale (VAS)
Description
Patients' difficulty in swallowing will be questioned using the Visual Analogue Scale (VAS). On a scale of ten centimeters, patients will be asked to mark the appropriate level of dysphagia 0: No dysphagia, 10: Very severe dysphagia.
Time Frame
before intervention, immediately after intervention, 3 months after the intervention
Title
Change in Laryngostroboscopy Examination
Description
In the Istanbul Faculty of Medicine Otorhinolaryngology Diseases Clinic, evaluations will be made by the Ear Nose Throat Specialist. Whether there is vocal cord paresis and paralysis and whether glottic patency is evaluated in the laryngostroboscopic examination.
Time Frame
before intervention, immediately after intervention
Title
Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Description
Fiberoptic endoscopic swallowing assessment will be performed by the otolaryngologist doctor before and immediately after the treatment. In the fiberoptic endoscopic swallowing assessment, the condition of the patient according to the penetration aspiration scale will be checked. Grade 1 represents the best and grade 7 the worst on the penetration aspiration scale.
Time Frame
before intervention, immediately after intervention
Title
Change in Voice-Related Quality of Life (V-RQOL) Score
Description
This ten-item scale is a scale designed for adult populations with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The answer points for each question range from 1 (few problems) to 5 (serious problems). A total score change on this scale will be used to evaluate patients.
Time Frame
before intervention, immediately after intervention, 3 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: After the first week after a stroke, detecting dysphagia by using bedside water assessment test Lesion location is shown by MRI or CT Unsupported sitting balance The score of Mini-mental state examination test (MMSE) 20 and above Over 18 years old Exclusion Criteria: Global aphasia or cognitive disorders that may affect the understanding of the instructions Patients with major medical problems that may affect participation Tracheostomy presence Previous neck surgery To have received radiotherapy in the head or neck area Presence of a cardiac pacemaker or a history of epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Tarihçi, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia

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