DysphagiaNCT07100262
Effect of Pulsed Electromagnetic Therapy on Chronic Dysphagia in Elderly Post-stroke Patients
A study testing Effortful swallow exercise and Pulsed electromagnetic therapy in people with Dysphagia, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the effect of pulsed electromagnetic therapy on chronic dysphagia in elderly post-stroke Patients. Read more about this study
- Who is it for?
- Ages 66 to 75 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Effortful swallow exercise and Pulsed electromagnetic therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 66 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients of both genders with chronic dysphagia.
- Their ages will be more than 65 years.
- Patients with body mass index (BMI) from 20kg/ m2 to 30kg/ m2.
- Patients had a stroke 6 months ago or more.
- Dysphagia symptoms started from the stroke time and continue till now.
Who cannot join
- Patients with anterior neck past surgeries, recent thoracic surgery and recent abdominal surgeries.
- Patients with neck tumors or traumatic lacerations on neck.
- Patients with cerebral hemorrhage affecting mainly oropharyngeal muscles.
- Patients with heart failure, myocardial infarction.
- Patients with any pulmonary diseases like plural effusion, pneumothorax, pulmonary fibrosis, emphysema.
- Cancer patients with or without metastasis.
Show all 10Show fewer
- Patients with Alzheimer and Dementia.
- Blood pressure of less than 100/60 mmHg or more than 140/90 mmHg.
- Patients with psychological problems.
- Patients with psoriasis, burn and any dermatological problems in neck area.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to determine the effect of pulsed electromagnetic therapy on chronic dysphagia in elderly post-stroke Patients.
Read the detailed description
Elders suffer from chronic dysphagia mainly after stroke (more than 6 months). Sarcopenia has been defined as a progressive and generalized disorder of skeletal muscle that involves accelerated loss of muscle mass and function. The prevalence of sarcopenia worldwide is up to 15% in healthy elderly, approximately 76% of acutely hospitalized elderly patients, and up to 69% of patients admitted for post-acute geriatric rehabilitation mainly post neurological stroke. This case series report is the first in the world scientific literature to demonstrate the effectiveness of Pulsed Electro Magnetic Frequency (PEMF) in gaining muscle strength and functionality in elderly sarcopenic patients. PEMF therapy, at least for the treatment of sarcopenia in the elderly, can be considered as the definitive evolution of electrical currents, with greater effectiveness and acceptance by the patient.
Skeletal muscle atrophy, a condition characterized by decreased muscle mass and contractility, is commonly observed in various pathological states, including prolonged inactivity, malnutrition and dysphagia. Findings examined in this trial suggest that antioxidants and Pulsed Magnetic Frequency (PMF) may alleviate impaired protein synthesis and degradation pathways in skeletal muscle atrophy. PMF showed a positive effect on the anabolic pathway.
A total of 26 studies were identified. Their intervention goals aimed to rehabilitate a broad spectrum of muscle groups within the oral cavity and pharynx and to improve the functions of swallowing, speech, facial expressions, or sleep breathing. Protocol duration ranged from 1 to 13 weeks, with various exercise repetitions (times per day) and frequency (days per week). Half of the studies reported using feedback to support the training, and these studies varied in the feedback strategy and technology tool. A total of 37 unique outcome measures were identified. Conclusions: This review demonstrated inconsistency across published studies in intervention goals and exercise protocols. It has also identified current limitations and provided recommendations for the selection of outcome measures while advancing a multidisciplinary view of oral and pharyngeal exercises in post-stroke recovery across relevant functions. The present study will examine effect of pulsed electromagnetic therapy on chronic dysphagia in elderly post stroke patients.
- Conditions
- Dysphagia
- Being tested
- Effortful swallow exercise, Pulsed electromagnetic therapy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effortful swallow exerciseOther
The participants will be practiced effortful swallow exercises as follows:
When you are ready to swallow your saliva, squeeze your tongue against the roof of your mouth.
- As you swallow squeeze all the muscles in your throat. Imagine you are trying to swallow a large tablet or a golf ball.
- If it has been recommended by your speech and language therapist, this exercise may be repeated when eating and drinking.
Frequency of exercise:
Exercises will be two 30-minutes sessions of effortful swallow practice daily, 5 days/week.
For every patient: 4 sets (1 set = 8-12 repetitions) 5 days/week, for 18 weeks.
Pulsed electromagnetic therapyDevice
The participants will receive pulsed electromagnetic therapy as the following:
Position of patient: supine lying position with head supported by pillow. Sleeve of device: above anterior neck area.
Parameters of application of device: according to programs for sarcopenia and muscular pain as the following:
Power: 30 GAUSS. Frequency: in first 6weeks: 5Hz - second 6weeks: 10Hz - last 6weeks: 15Hz. Time of session: 30 min. Sessions frequency: 3 sessions per week. Time of treatment course: 18 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Effortful swallow exercise | Active comparator | The participants will receive two 30-minutes sessions of effortful swallow practice daily, 5 days/week, for 18 weeks. Receives: Other: Effortful swallow exercise |
| Pulsed electromagnetic therapy and effortful swallow exercise | Experimental | The participants will receive pulsed electromagnetic therapy for 30 minutes, 3 sessions weekly , in addition to two 30-minutes sessions of effortful swallow practice daily, 5 days/week, for 18 weeks. Receives: Other: Effortful swallow exercise; Device: Pulsed electromagnetic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration Aspiration Score (PAS)
Standardized Fiberoptic Endoscopic Evaluation of Swallowing (FEES)will be applied for all subjects in both groups two times (before and after the trial), and PAS will be calculated. It is an 8-point ordinal scale, with 1 representing the least and 8 representing the highest or most severe score.
- Material does not enter airway.
- Material enters the airway, remains above the vocal folds, and is ejected from the airway.
- As point 2, but is not ejected from the airway.
- Material enters the airway, contacts the vocal folds, and is ejected from the airway.
- As point 4, but is not ejected from the airway.
- Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway.
- Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort.
- Material enters the airway, passes below the vocal folds, and no effort is made to eject.
Measured: 18 weeks
Eating Assessment Tool (EAT)-10
It is a dysphagia screening tool developed to identify people at high risk of swallowing disorders. I twill be used for all subjects in both groups two times, the first before beginning of trial and the other after finishing the trial. it includes 10 items with 4 responses for each ranged from 0 to 4. 0 indicates no problem, and 4 indicates severe problem. Higher total score indicates more severity of the problem.
Measured: 18 weeks
Functional Oral Intake Scale (FOIS):
It is a seven-point ordinal scale used to assess the functional ability of individuals with dysphagia to consume food and liquids orally. It was initially developed for stroke patients but is now widely used in adults and children with various neurological and other conditions affecting swallowing. The scale ranges from level 1 (no oral intake) to level 7 (total oral intake with no restrictions).
Level 1: No oral intake. Level 2: Tube dependent with minimal or inconsistent oral intake. Level 3: Tube supplement with consistent oral intake. Level 4: Total oral intake of a single food consistency. Level 5: Total oral intake of multiple consistencies requiring special preparation.
Level 6: Total oral intake of all consistencies with no special preparation. Level 7: Total oral intake with no restrictions.
Measured: 18 weeks
Serum Creatinine/Cystatin C Ratio
Mindray Diluent Lyse device model BA88A will be used to assess Serum Creatinine/Cystatin C Ratio for all participants in both groups before and after treatment. It has been investigated as a potential marker for sarcopenia (age-related muscle loss). A typical range for the serum creatinine/cystatin C ratio might be between 6.45 and 24.14 for males and 4.62 and 23.49 for females. A higher ratio is associated with greater muscle mass, and lower ratios potentially linked to muscle loss.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start5 Aug 2025 (estimated)
- Primary completion14 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mostafa Mohamed, Cairo University
- Investigators
- Ayatallah Sheikhany, Professor, Study director, Cairo UniversityAkram Sayed, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100262
- Sponsor's protocol ID
- P.T.REC/012/005715
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Electromagnetic Therapy on Chronic Dysphagia in Elderly Post-stroke Patients
- ClinicalTrials.gov ID
- NCT07100262
- Acronym / sponsor ID
- P.T.REC/012/005715
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 Aug 2025 (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 will be conducted to determine the effect of pulsed electromagnetic therapy on chronic dysphagia in elderly post-stroke Patients.
Detailed description
Elders suffer from chronic dysphagia mainly after stroke (more than 6 months). Sarcopenia has been defined as a progressive and generalized disorder of skeletal muscle that involves accelerated loss of muscle mass and function. The prevalence of sarcopenia worldwide is up to 15% in healthy elderly, approximately 76% of acutely hospitalized elderly patients, and up to 69% of patients admitted for post-acute geriatric rehabilitation mainly post neurological stroke. This case series report is the first in the world scientific literature to demonstrate the effectiveness of Pulsed Electro Magnetic Frequency (PEMF) in gaining muscle strength and functionality in elderly sarcopenic patients. PEMF therapy, at least for the treatment of sarcopenia in the elderly, can be considered as the definitive evolution of electrical currents, with greater effectiveness and acceptance by the patient.
Skeletal muscle atrophy, a condition characterized by decreased muscle mass and contractility, is commonly observed in various pathological states, including prolonged inactivity, malnutrition and dysphagia. Findings examined in this trial suggest that antioxidants and Pulsed Magnetic Frequency (PMF) may alleviate impaired protein synthesis and degradation pathways in skeletal muscle atrophy. PMF showed a positive effect on the anabolic pathway.
A total of 26 studies were identified. Their intervention goals aimed to rehabilitate a broad spectrum of muscle groups within the oral cavity and pharynx and to improve the functions of swallowing, speech, facial expressions, or sleep breathing. Protocol duration ranged from 1 to 13 weeks, with various exercise repetitions (times per day) and frequency (days per week). Half of the studies reported using feedback to support the training, and these studies varied in the feedback strategy and technology tool. A total of 37 unique outcome measures were identified. Conclusions: This review demonstrated inconsistency across published studies in intervention goals and exercise protocols. It has also identified current limitations and provided recommendations for the selection of outcome measures while advancing a multidisciplinary view of oral and pharyngeal exercises in post-stroke recovery across relevant functions. The present study will examine effect of pulsed electromagnetic therapy on chronic dysphagia in elderly post stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effortful swallow exercise | Active comparator | Other: Effortful swallow exerciseThe participants will receive two 30-minutes sessions of effortful swallow practice daily, 5 days/week, for 18 weeks. |
| Pulsed electromagnetic therapy and effortful swallow exercise | Experimental | Other: Effortful swallow exercise, Device: Pulsed electromagnetic therapyThe participants will receive pulsed electromagnetic therapy for 30 minutes, 3 sessions weekly , in addition to two 30-minutes sessions of effortful swallow practice daily, 5 days/week, for 18 weeks. |
Who may qualify
- Ages
- 66 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Elderly patients of both genders with chronic dysphagia.
- Their ages will be more than 65 years.
- Patients with body mass index (BMI) from 20kg/ m2 to 30kg/ m2.
- Patients had a stroke 6 months ago or more.
- Dysphagia symptoms started from the stroke time and continue till now.
Key exclusion criteria (10 listed)
- Patients with anterior neck past surgeries, recent thoracic surgery and recent abdominal surgeries.
- Patients with neck tumors or traumatic lacerations on neck.
- Patients with cerebral hemorrhage affecting mainly oropharyngeal muscles.
- Patients with heart failure, myocardial infarction.
- Patients with any pulmonary diseases like plural effusion, pneumothorax, pulmonary fibrosis, emphysema.
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 |
|---|---|---|
| Effortful swallow exerciseThe participants will be practiced effortful swallow exercises as follows: When you are ready to swallow your saliva, squeeze your tongue against the roof of your mouth. B) As you swallow squeeze all the muscles in your throat. Imagine you are trying to swallow a large tablet or a golf ball. C) If it has been recommended by your speech and language therapist, this exercise may be repeated when eating and drinking. Frequency of exercise: Exercises will be two 30-minutes sessions of effortful swallow practice daily, 5 days/week. For every patient: 4 sets (1 set = 8-12 repetitions) 5 days/week, for 18 weeks. | Other | Effortful swallow exercise, Pulsed electromagnetic therapy and effortful swallow exercise |
| Pulsed electromagnetic therapyThe participants will receive pulsed electromagnetic therapy as the following: Position of patient: supine lying position with head supported by pillow. Sleeve of device: above anterior neck area. Parameters of application of device: according to programs for sarcopenia and muscular pain as the following: Power: 30 GAUSS. Frequency: in first 6weeks: 5Hz - second 6weeks: 10Hz - last 6weeks: 15Hz. Time of session: 30 min. Sessions frequency: 3 sessions per week. Time of treatment course: 18 weeks. | Device | Pulsed electromagnetic therapy and effortful swallow exercise |
Primary outcome
Penetration Aspiration Score (PAS)
Time frame: 18 weeks
Standardized Fiberoptic Endoscopic Evaluation of Swallowing (FEES)will be applied for all subjects in both groups two times (before and after the trial), and PAS will be calculated. It is an 8-point ordinal scale, with 1 representing the least and 8 representing the highest or most severe score. 1. Material does not enter airway. 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. As point 2, but is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. As point 4, but is not ejected from the airway. 6. Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject.
Eating Assessment Tool (EAT)-10
Time frame: 18 weeks
It is a dysphagia screening tool developed to identify people at high risk of swallowing disorders. I twill be used for all subjects in both groups two times, the first before beginning of trial and the other after finishing the trial. it includes 10 items with 4 responses for each ranged from 0 to 4. 0 indicates no problem, and 4 indicates severe problem. Higher total score indicates more severity of the problem.
Functional Oral Intake Scale (FOIS):
Time frame: 18 weeks
It is a seven-point ordinal scale used to assess the functional ability of individuals with dysphagia to consume food and liquids orally. It was initially developed for stroke patients but is now widely used in adults and children with various neurological and other conditions affecting swallowing. The scale ranges from level 1 (no oral intake) to level 7 (total oral intake with no restrictions). Level 1: No oral intake. Level 2: Tube dependent with minimal or inconsistent oral intake. Level 3: Tube supplement with consistent oral intake. Level 4: Total oral intake of a single food consistency. Level 5: Total oral intake of multiple consistencies requiring special preparation. Level 6: Total oral intake of all consistencies with no special preparation. Level 7: Total oral intake with no restrictions.
Serum Creatinine/Cystatin C Ratio
Time frame: 18 weeks
Mindray Diluent Lyse device model BA88A will be used to assess Serum Creatinine/Cystatin C Ratio for all participants in both groups before and after treatment. It has been investigated as a potential marker for sarcopenia (age-related muscle loss). A typical range for the serum creatinine/cystatin C ratio might be between 6.45 and 24.14 for males and 4.62 and 23.49 for females. A higher ratio is associated with greater muscle mass, and lower ratios potentially linked to muscle loss.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
Ayatallah Sheikhany, Professor study director
Cairo University
Akram Sayed, Professor study chair
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 Effortful swallow exercise and Pulsed electromagnetic therapy in people with Dysphagia, 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mostafa, PHD (01092222122, mohamedsharawy1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Score (PAS) (time frame: 18 weeks). The study lists 4 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 3 Aug 2025.