StrokeNCT07367490
Neuromuscular Electrical Stimulation Versus Electromyographic Biofeedback on Oropharyngeal Dysphagia in Patients With Stroke
A study testing Neuromuscular electrical stimulation, Electromyographic Biofeedback and Selected physical therapy program in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Neuromuscular electrical stimulation, Electromyographic Biofeedback and Selected physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Patients with previous operation or injury in the neck.
- Patients with deficits in attention or cognition.
- Patients with cardiac pacemaker or history of seizures.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the effect of neuromuscular electrical stimulation versus electromyographic biofeedback on swallowing function and dysphagia severity in patients with stroke.
Read the 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.
- Conditions
- Stroke
- Being tested
- Neuromuscular electrical stimulation, Electromyographic Biofeedback, Selected physical therapy program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
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 BiofeedbackDevice
Also called EMG 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.
Selected physical therapy programOther
Also called Physical therapy exercises
It includes lips exercise, tongue exercises, effortful swallowing maneuver, Mendelsohn maneuver and neck muscle exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Jul 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayaa yousri hussien khalifa, Cairo University
- Investigators
- Nagwa Ibrahim Rehab, PhD, Study chair, Ass. Professor, Cairo UniversityNoura Abd Elhamid Elkafrawy, PhD, Study director, Lecturer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367490
- Sponsor's protocol ID
- P.T.REC/012/0059525
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation Versus Electromyographic Biofeedback on Oropharyngeal Dysphagia in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07367490
- Acronym / sponsor ID
- P.T.REC/012/0059525
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of neuromuscular electrical stimulation versus electromyographic biofeedback on swallowing function and dysphagia severity in patients with stroke.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation + Selected physical therapy program | Experimental | Device: Neuromuscular electrical stimulation, Other: Selected physical therapy programIt included 20 patients who received neuromuscular electrical stimulation using VitalStim Plus in addition to selected physical therapy program. |
| Electromyographic Biofeedback + Selected physical therapy program | Experimental | Device: Electromyographic Biofeedback, Other: Selected physical therapy programIt included 20 patients who will receive electromyographic biofeedback in addition to selected physical therapy program. |
| Selected physical therapy program | Active comparator | Other: Selected physical therapy programIt included 20 patients who received selected physical therapy program only. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Patients with distributed conscious level.
- Uncooperative patients.
- Patients with psychiatric disorders.
- Patients with syncope.
- Patients with dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationTwo 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. | Device | Neuromuscular electrical stimulation + Selected physical therapy program |
| Electromyographic BiofeedbackAlso: EMG BiofeedbackIt is a safe, simple, noninvasive treatment method means that can collect electromyographic signal of muscle activity for quantitative and qualitative analysis of neuromuscular functions. | Device | Electromyographic Biofeedback + Selected physical therapy program |
| Selected physical therapy programAlso: Physical therapy exercisesIt includes lips exercise, tongue exercises, effortful swallowing maneuver, Mendelsohn maneuver and neck muscle exercise. | Other | Electromyographic Biofeedback + Selected physical therapy program, Neuromuscular electrical stimulation + Selected physical therapy program, Selected physical therapy program |
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagwa Ibrahim Rehab, PhD study chair
Ass. Professor, Cairo University
Noura Abd Elhamid Elkafrawy, PhD study director
Lecturer, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation, Electromyographic Biofeedback and Selected physical therapy program in people with Stroke, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Oral Intake Scale (FOIS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.