Neuromuscular Electrical Stimulation Versus Electromyographic Biofeedback on Oropharyngeal Dysphagia in Patients With Stroke

January 28, 2026 updated by: Hayaa yousri hussien khalifa, Cairo University
This study aims to investigate the effect of neuromuscular electrical stimulation versus electromyographic biofeedback on swallowing function and dysphagia severity in patients with stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dysphagia is a common symptom seen in stroke patients, it is affected patients' nutrition supply, and may causes aspiration pneumonia. To solve the problem of nutritional support, nasogastric tubes are routinely indwelling to provide nutrition. This feeding method sometimes causes food reflux, aspiration, pneumonia, and discomfort and self-image acceptance.

Traditional exercise based on exercise like Shaker exercise, Chin resisted exercise and effortful training. Shaker exercise here is designed by professor Shaker has been regarded as popular rehabilitation training for dysphagia. Shaker exercise can strengthen upper esophageal sphincter, improving swallowing function.

Chin resisted exercise were developed to strengthen the suprahyoid muscles, whose contractions facilitate the opening of the upper esophageal sphincter, thereby improving bolus transfer.

Many studies reported that neuromuscular electrical stimulation can improve the swallowing function by enhancing swallowing coordination of post-stroke dysphagia patients. The improving of swallowing by surface electrical stimulation enhances raising and contraction of the hyoid bone of patients during swallowing. Neuromuscular electrical stimulation (VitalStim Plus), a method for stimulating muscles with short electrical pulses, is widely used in the therapy of stroke patients with pharyngeal dysphagia. It enhances the strength of the muscles associated with swallowing and facilitates reflex swallowing by sensory stimulation.

Using surface electromyography in post-stroke dysphagia cases increase ability of submental muscles activity and performance. Biofeedback or surface electromyography to ensure that target swallowing movements are being trained during rehabilitation, rather than maladaptive movements. Applying EMG-biofeedback add motivation to the therapy.

Both neuromuscular electrical stimulation and surface electromyography biofeedback improve recovery of swallowing function in stroke patients with dysphagia but yet there is no evidence about the most effective modality for improving swallowing in patients with acute stroke. So, this study was conducted to investigate and compare between effect of neuromuscular electrical stimulation and electromyographic biofeedback on swallowing function and dysphagia severity in patients with stroke.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient's age were range from 45 to 60 years old.
  • Presence of dysphagia from 3 weeks to 3 months, with preservation of cough reflex.
  • Patients with severe moderate dysphagia according to dysphagia outcome and severity scale.
  • Patients with sufficient cognitive abilities that enables them to understand and follow instructions.

Exclusion Criteria:

  • Patients with distributed conscious level.
  • Uncooperative patients.
  • Patients with psychiatric disorders.
  • Patients with syncope.
  • Patients with dementia.
  • Patients with history of dysphagia prior to onset of stroke.
  • Patients with previous operation or injury in the neck.
  • Patients with deficits in attention or cognition.
  • Patients with cardiac pacemaker or history of seizures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuromuscular electrical stimulation + Selected physical therapy program
It included 20 patients who received neuromuscular electrical stimulation using VitalStim Plus in addition to selected physical therapy program.
Other: Selected physical therapy program
It includes lips exercise, tongue exercises, effortful swallowing maneuver, Mendelsohn maneuver and neck muscle exercise.
Other Names:
  • Physical therapy exercises
Device: Neuromuscular electrical stimulation
Two pairs of electrodes were placed horizontally over the submental and paratracheal (thyroid cartilage) regions. Surged neuromuscular electrical stimulation was applied at a frequency of 80 Hz with a pulse duration of 200-300 µs. Stimulation was delivered for 30 minutes per session, five days per week, over an eight-week period.
Experimental: Electromyographic Biofeedback + Selected physical therapy program
It included 20 patients who will receive electromyographic biofeedback in addition to selected physical therapy program.
Other: Selected physical therapy program
It includes lips exercise, tongue exercises, effortful swallowing maneuver, Mendelsohn maneuver and neck muscle exercise.
Other Names:
  • Physical therapy exercises
Device: Electromyographic Biofeedback
It is a safe, simple, noninvasive treatment method means that can collect electromyographic signal of muscle activity for quantitative and qualitative analysis of neuromuscular functions.
Other Names:
  • EMG Biofeedback
Active Comparator: Selected physical therapy program
It included 20 patients who received selected physical therapy program only.
Other: Selected physical therapy program
It includes lips exercise, tongue exercises, effortful swallowing maneuver, Mendelsohn maneuver and neck muscle exercise.
Other Names:
  • Physical therapy exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Oral Intake Scale (FOIS)
Time Frame: 8 weeks
The Functional Oral Intake Scale (FOIS) is a validated, seven-point observer-rated scale used to assess and monitor functional oral intake without increasing patient burden. Originally developed for individuals with neurogenic dysphagia, it demonstrates high reliability, interrater validity, and sensitivity to change. The scale ranges from level 1 (nothing by mouth) to level 7 (total oral diet with no restrictions) and is applied by trained observers to track eating abilities over time.
8 weeks
Dysphagia Outcome and Severity Scale (DOSS)
Time Frame: 8 weeks
The Dysphagia Outcome and Severity Scale (DOSS) is an easy-to-administer, seven-point clinician-rated scale used to assess dysphagia severity and guide dietary and nutritional recommendations. It demonstrates strong intra- and interrater reliability and is based on objective parameters such as oral bolus transfer, pharyngeal residue, and airway protection. The scale ranges from level 1 (severe dysphagia with no safe oral intake) to level 7 (normal swallowing with no restrictions).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Nagwa Ibrahim Rehab, PhD, Ass. Professor, Cairo University
  • Study Director: Noura Abd Elhamid Elkafrawy, PhD, Lecturer, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/0059525

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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