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

NCT07367490 | Completed

• 1 other identifier: P.T.REC/012/0059525
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of neuromuscular electrical stimulation versus electromyographic biofeedback on swallowing function and dysphagia severity in patients with stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Functional Oral Intake Scale (FOIS)

  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)

  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

Study Arms (3)

Neuromuscular electrical stimulation + Selected physical therapy program

EXPERIMENTAL

It included 20 patients who received neuromuscular electrical stimulation using VitalStim Plus in addition to selected physical therapy program.

Device: Neuromuscular electrical stimulation; Other: Selected physical therapy program

Electromyographic Biofeedback + Selected physical therapy program

EXPERIMENTAL

It included 20 patients who will receive electromyographic biofeedback in addition to selected physical therapy program.

Device: Electromyographic Biofeedback; Other: Selected physical therapy program

Selected physical therapy program

ACTIVE COMPARATOR

It included 20 patients who received selected physical therapy program only.

Other: Selected physical therapy program

Interventions

Neuromuscular electrical stimulation DEVICE

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.

Neuromuscular electrical stimulation + Selected physical therapy program

Electromyographic Biofeedback DEVICE

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.

Also known as: EMG Biofeedback

Electromyographic Biofeedback + Selected physical therapy program

Selected physical therapy program OTHER

It includes lips exercise, tongue exercises, effortful swallowing maneuver, Mendelsohn maneuver and neck muscle exercise.

Also known as: Physical therapy exercises

Electromyographic Biofeedback + Selected physical therapy program; Neuromuscular electrical stimulation + Selected physical therapy program; Selected physical therapy program

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Nagwa Ibrahim Rehab, PhD

  Ass. Professor, Cairo University

  STUDY CHAIR

• Noura Abd Elhamid Elkafrawy, PhD

  Lecturer, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 26, 2026
• Study Start: July 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

EG (1)