Effect of Pulsed Electromagnetic Therapy on Chronic Dysphagia in Elderly Post-stroke Patients

NCT ID: NCT07100262

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-02-28

Brief Summary

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.

Conditions

Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Effortful swallow exercise

The participants will receive two 30-minutes sessions of effortful swallow practice daily, 5 days/week, for 18 weeks.

Group Type: ACTIVE_COMPARATOR

Effortful swallow exercise

Intervention Type: OTHER

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.

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.

Pulsed electromagnetic therapy and effortful swallow exercise

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.

Group Type: EXPERIMENTAL

Effortful swallow exercise

Intervention Type: OTHER

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.

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.

Pulsed electromagnetic therapy

Intervention Type: DEVICE

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.

Interventions

Effortful swallow exercise

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.

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.

Intervention Type: OTHER

Pulsed electromagnetic therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 66 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Mostafa Mohamed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayatallah Sheikhany, Professor

Role: STUDY_DIRECTOR

Cairo University

Akram Sayed, Professor

Role: STUDY_CHAIR

Cairo University

Locations

Mohamed Ahmed Mostafa

Cairo, , Egypt

Countries

Egypt

Central Contacts

Mohamed Mostafa, PHD

Role: CONTACT

mohamedsharawy1991@gmail.com

01092222122

Heba Abdel Ghfar, Professor

Role: CONTACT

hebaelshweety@gmail.com

01005056590

Other Identifiers

P.T.REC/012/005715

Identifier Type: -

Identifier Source: org_study_id