The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial
Phase: NA
Conditions: Stroke, Swallowing Disorder, Dysphagia, Stroke, Complication, Cerebrovascular Accident
Sponsor: Istanbul University

Document Date: 2 March 2020 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CLINICAL STUDY PLAN 
The Effects of Neuromuscular Electrical 
Stimulation on Swallowing Functions in 
Stroke Patients With Dysphagia 
 

Document Date: 2 March 2020 
2
 
ClinicalTrials.gov Results Data Element Definitions  
for Interventional and Observational Studies 
 
1. Participant Flow 
“ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessed for eligibility (n= ) 
Excluded (n= ) 
• Not meeting inclusion criteria (n= ) 
• Declined to participate (n= ) 
• Other reasons (n= ) 
Randomized (n= ) 
Allocation  
Allocated to intervention (n= ) 
 Received allocated intervention (n= ) 
 Did not receive allocated intervention 
(give reasons) (n= )  
Follow-Up  
Lost to follow-up (give reasons) (n= ) 
Discontinued intervention (give reasons) 
(n= ) 
Allocated to intervention (n= ) 
 Received allocated intervention (n= ) 
 Did not receive allocated intervention 
(give reasons) (n= )  
Lost to follow-up (give reasons) (n= ) 
Discontinued intervention (give reasons) 
(n= ) 
Enrollment 
Analysed (n= ) 
 Excluded from analysis (give reasons) 
(n= )  
Analysis 
Analysed (n= ) 
 Excluded from analysis (give reasons) 
(n= )  
Follow-Up  
Lost to follow-up (give reasons) (n= ) 
Discontinued intervention (give reasons) 
(n= ) 
Lost to follow-up (give reasons) (n= ) 
Discontinued intervention (give reasons) 
(n= ) 

Document Date: 2 March 2020 
3
 
Period(s) *  
Our study was created by planning a 3-month follow-up period. Information about the number 
of patients at the beginning and end of the study will be reported when the study is completed. 
Definition: Discrete stages of a clinical study during which numbers of participants at specific 
significant events or points of time are reported.  
 
2. Baseline Characteristics 
 
Patients' age, gender, educational status, height and weight, additional diseases, medications 
used, time after the patient's stroke, duration of hospitalization in the acute period after stroke, 
stroke type (ischemic / hemorrhagic), lesion region, degree of ambulation according to 
functional ambulation classification will be recorded at the beginning of the study. 
Arms 
Assigned Interventions 
Experimental: 
Neuromuscular 
Electrical Stimulation 
(NMES) with TDT 
Device: Procedure: Neuromuscular Electrical Stimulation with 
TDT  
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. 
Active Comparator: 
Traditional 
Dysphagia Therapy 
(TDT) 
Behavioral: Procedure: Traditional Dysphagia Therapy (TDT)  
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. 

Document Date: 2 March 2020 
4
Overall Number of Baseline Participants *  
 
A total of 38 patients were planned to be included in the study, including 19 in each group. 
Baseline Measure Information *  
Patients' age, gender, educational status, height and weight, additional diseases, medications 
used, time after the patient's stroke, duration of hospitalization in the acute period after stroke, 
stroke type (ischemic / hemorrhagic), lesion region, degree of ambulation according to 
functional ambulation classification will be recorded at the beginning of the study. The 
change in Functional Oral Intake Scale (FOIS) will be our primary outcome measure in our 
research. 
Arms 
Assigned Interventions 
Experimental: 
Neuromuscular 
Electrical Stimulation 
(NMES) with TDT 
Device: Procedure: Neuromuscular Electrical Stimulation with 
TDT  
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. 
Active Comparator: 
Traditional 
Dysphagia Therapy 
(TDT) 
Behavioral: Procedure: Traditional Dysphagia Therapy (TDT)  
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. 

Document Date: 2 March 2020 
5
Baseline Measure Title *  
Definition: The name of the baseline or demographic characteristic measured in the clinical 
study. Select as many as needed.  
• 
Study-Specific Measure *§ (Select as many as needed)  
• 
Age * (Select at least one of the following):  
• 
Age, Continuous: For example - mean or median age  
• 
Sex/Gender * (Select at least one of the following):  
• 
Sex: Female, Male  
• 
Race and Ethnicity *§  
• 
Race and Ethnicity Not Collected  
 
Measure Type *  
Count of Participants  
Measure of Dispersion *  
Not Applicable (only if Measure Type is "Number", "Count of Participants", or "Count of 
Units")  
Baseline Measure Data *  
When the investigation is completed, information about each baseline measures data will be 
updated. 
Unit of Measure *  
height (cm) and weight (kg) 
3. Outcome Measures 
 
Primary Outcome Measure: 
• 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. 
[Time Frame: before intervention, immediately after intervention, 3 months after the 
intervention] 
 

Document Date: 2 March 2020 
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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. 
[Time Frame: before intervention, immediately after intervention, 3 months after the 
intervention] 
• 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. 
[Time Frame: before intervention, immediately after intervention, 3 months after the 
intervention] 
• 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. 
[Time Frame: before intervention, immediately after intervention, 3 months after the 
intervention] 
• 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. 
[Time Frame: before intervention, immediately after intervention] 
• Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES) 
FEES 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] 
• 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. 
[Time Frame: before intervention, immediately after intervention, 3 months after the 
intervention] 
 
 

Document Date: 2 March 2020 
7
 
 
 
 
Analysis Population Information  
Overall Number of Participants Analyzed *  
A total of 38 patients were planned to be included in the study. 
 
Type of Units Analyzed [*]  
Arms 
Assigned Interventions 
Experimental: 
Neuromuscular 
Electrical Stimulation 
(NMES) with TDT 
Device: Procedure: Neuromuscular Electrical Stimulation with 
TDT  
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. 
Active Comparator: 
Traditional 
Dysphagia Therapy 
(TDT) 
Behavioral: Procedure: Traditional Dysphagia Therapy (TDT)  
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. 

Document Date: 2 March 2020 
8
The analysis will be based on participants. 
 
Outcome Measure Data Table  
 
Measure Type *  
Count of Participants  
Measure of Dispersion/Precision *  
80% Confidence Interval 
 
Statistical Analyses [*]  
The required sample size was determined by power analysis based on previous studies. 
[G * Power, Version: 3.1.9.2 Statistical Packages, Power Analysis for Repeated (ANOVA) 
Type 1 error probability was 0.05%, power of the test was 80%.] The minimum required 
number of people for each group was calculated as 17. It was predicted that 10% of the 
patients would be excluded during the study, and a total of 38 patients were planned to be 
included in the study, including 19 in each group. 
Descriptive statistics of numerical variables will be given as mean, standard deviation, 
median, minimum and maximum. Descriptive statistics of qualitative variables will be given 
as numbers and percentages. Whether numerical variables show normal distribution will be 
investigated with Shapiro Wilk test. 
In the comparison of two independent groups, Student's t test will be used for variables with 
normal distribution and Mann Whitney U test will be used for non-normally distributed 
variables. In comparing two dependent groups, Paired t test will be used for variables with 
normal distribution and Wilcoxon test will be used for non-normally distributed variables. 
A statistical significance level of 0.05 will be taken, p <0.05 will be considered statistically 
significant. SPSS package program will be used in calculations. 
 
4. Adverse Event Information 
 
Information for completing three tables summarizing adverse events.  
1. All-Cause Mortality: *§ Mortality is not expected in our study. 
2. Serious Adverse Events: * Serious adverse events are not expected in our study. 
3. Other (Not Including Serious) Adverse Events: * Adverse event due to the study is 
not expected. If any adverse event will be seen it will be reported. 
Time Frame *§  
Adverse event data will be collected between 15 April 2020 and 15 April 2021. 
 
Adverse Event Reporting Description [*]  
Patients will be invited for a checkup immediately after the intervention and three months 

Document Date: 2 March 2020 
9
after the intervention. When patients encounter any problem beyond the specified times, they 
will reach out to the researcher through the contact number given to them and report the 
problem. 
Collection Approach for Table Default *§ (or Collection Approach for each Adverse 
Event Term required)  
 
Systematic Assessment: Patients will be invited for a checkup immediately after the 
intervention and three months after the intervention. 
 
Arm/Group Information *  
Patients who meet the inclusion criteria will be randomized into two groups by computer 
program after being enumerated according to the order of application. Traditional dysphagia 
therapy and neuromuscular electrical stimulation (NMES) will be applied to 19 patients 
selected for Experimental Group. Traditional dysphagia therapy will be applied to 19 patients 
selected for Active Comparator Group.   
Arm/Group Title *  
Arm:  Experimental: Neuromuscular Electrical Stimulation (NMES) with TDT 
Arm:  Active Comparator: Traditional Dysphagia Therapy (TDT) 
Arm/Group Description *§  
Traditional dysphagia therapy and neuromuscular electrical stimulation (NMES) will be 
applied to 19 patients selected for the Experimental Group. NMES application and Traditional 
Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.  
Traditional dysphagia therapy will be applied to 19 patients selected for Active Comparator 
Group.  Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week 
for 3 weeks. 
 
 
 
Total Number Affected by All-Cause Mortality *§  
0 
Total Number at Risk for All-Cause Mortality *§  
0 
Total Number Affected by Any Serious Adverse Event *  
0  

Document Date: 2 March 2020 
10
Total Number at Risk for Serious Adverse Events * (or Number at Risk for each Serious 
Adverse Event Term required)  
0  
Frequency Threshold for Reporting Other (Not Including Serious) Adverse Events *  
5 
Total Number Affected by Any Other (Not Including Serious) Adverse Event Above the 
Frequency Threshold *  
0 
Total Number at Risk for Other (Not Including Serious) Adverse Events * (or Number 
at Risk for each Other, [Not Including Serious], Adverse Event Term required)  
0 
Adverse Event Term *  
Unexpected impact that affects the course of the study. 
 
Organ System *  
General Disorders 
Collection Approach *§ (or Collection Approach for Table Default required)  
Systematic Assessment: Patients will be invited for a checkup immediately after the 
intervention and three months after the intervention. 
 
Number of Participants Affected *  
0 
Number of Participants at Risk *  
0  
 
 
5. Limitations and Caveats 
 
Overall Limitations and Caveats  
In our study, we compare two groups of patients who received therapy. However, creating a 
third group of patients and not applying any therapy program to this group may be more 
beneficial in terms of demonstrating the effectiveness of the therapies. 
 
6. Certain Agreements 
 
Information indicating whether there exists an agreement between the sponsor or its agent and 
the principal investigators (unless the sponsor is an employer of the principal investigators) 

Document Date: 2 March 2020 
11
that restricts in any manner the ability of the principal investigators (PIs), after the completion 
of the study, to discuss the results of the study at a scientific meeting or any other public or 
private forum, or to publish in a scientific or academic journal information concerning the 
results of the study. This does not include an agreement solely to comply with applicable 
provisions of law protecting the privacy of participants.  
Are all PIs Employees of Sponsor? *  
Definition: Indicate whether the principal investigator is an employee of the sponsor. Select 
one.  
• 
Yes: The principal investigator is an employee of the sponsor 
If "No" the following information is required:  
 
PI Disclosure Restriction Type  
Definition: There are no varying agreements.  
7. Results Point of Contact  
 
Point of contact for scientific information about the clinical study results information.  
Name or Official Title *  
Definition: Dr. Elif Tarihçi  
Organization Name *  
Definition: Istanbul University 
Phone: *§ +902124142000  
 
Extension (Ext.): 31737 
Email: *§ eliftarihci@hotmail.com