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

NCT04421937 | Completed

• 1 other identifier: Istanbul University, Istanbul
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Swallowing Disorder; Dysphagia; Stroke, Complication; Cerebrovascular Accident

Keywords

stroke; swallowing disorder; dysphagia; stroke rehabilitation; neuromuscular electrical stimulation; traditional dysphagia therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  before intervention, immediately after intervention, 3 months after the intervention

Secondary Outcomes (6)

• Change in Eating Assessment Tool-10 (EAT-10) Score

  before intervention, immediately after intervention, 3 months after the intervention

• Change in Swallowing-related Quality of Life (SWAL-QOL) Score

  before intervention, immediately after intervention, 3 months after the intervention

• Change in Visual Analog Scale (VAS)

  before intervention, immediately after intervention, 3 months after the intervention

• Change in Laryngostroboscopy Examination

  before intervention, immediately after intervention

• Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

  before intervention, immediately after intervention

Study Arms (2)

Neuromuscular Electrical Stimulation (NMES) with TDT

EXPERIMENTAL

Device: Procedure: Neuromuscular Electrical Stimulation with TDT

Traditional Dysphagia Therapy (TDT)

ACTIVE COMPARATOR

Behavioral: Procedure: Traditional Dysphagia Therapy (TDT)

Interventions

Procedure: Traditional Dysphagia Therapy (TDT) BEHAVIORAL

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.

Traditional Dysphagia Therapy (TDT)

Procedure: Neuromuscular Electrical Stimulation with TDT DEVICE

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.

Neuromuscular Electrical Stimulation (NMES) with TDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

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

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Elif Tarihçi, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: June 9, 2020
• Study Start: April 15, 2020
• Primary Completion: January 30, 2022
• Study Completion: February 16, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)