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

NCT ID: NCT04421937

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2022-02-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neuromuscular Electrical Stimulation (NMES) with TDT

Group Type: EXPERIMENTAL

Procedure: Neuromuscular Electrical Stimulation with TDT

Intervention Type: 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.

Traditional Dysphagia Therapy (TDT)

Group Type: ACTIVE_COMPARATOR

Procedure: Traditional Dysphagia Therapy (TDT)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Elif Tarihçi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elif Tarihçi, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

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

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Istanbul University, Istanbul

Identifier Type: -

Identifier Source: org_study_id