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

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT04421937

Collaborator

(none)

Enrollment

Location

Arms

22.1

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Swallowing Disorder Dysphagia Stroke, Complication Cerebrovascular Accident	Behavioral: Procedure: Traditional Dysphagia Therapy (TDT) Device: Procedure: Neuromuscular Electrical Stimulation with TDT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial

Actual Study Start Date :

Apr 15, 2020

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Feb 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Change in Functional Oral Intake Scale (FOIS) [before intervention, immediately after intervention, 3 months after the intervention]
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 [before intervention, immediately after intervention, 3 months after the intervention]
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 [before intervention, immediately after intervention, 3 months after the intervention]
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) [before intervention, immediately after intervention, 3 months after the intervention]
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 [before intervention, immediately after intervention]
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) [before intervention, immediately after intervention]
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 [before intervention, immediately after intervention, 3 months after the intervention]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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