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Completed

NCT Number: NCT07367490

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

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

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Key information

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Other names: EMG Biofeedback

selected physical therapy program

Other

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

Other names: Physical therapy exercises

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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