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

NCT07100262 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005715
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to determine the effect of pulsed electromagnetic therapy on chronic dysphagia in elderly post-stroke Patients.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (4)

• 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. 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.

  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.

  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.

  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.

  18 weeks

Study Arms (2)

Effortful swallow exercise

ACTIVE COMPARATOR

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

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.

Other: Effortful swallow exercise; Device: Pulsed electromagnetic therapy

Interventions

Effortful swallow exercise 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.

Effortful swallow exercise; Pulsed electromagnetic therapy and effortful swallow exercise

Pulsed electromagnetic therapy 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.

Pulsed electromagnetic therapy and effortful swallow exercise

Eligibility Criteria

• Age: 66 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mohamed Ahmed Mostafa

Cairo, Egypt

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ayatallah Sheikhany, Professor

  Cairo University

  STUDY DIRECTOR

• Akram Sayed, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mohamed Mostafa, PHD

CONTACT

01092222122; mohamedsharawy1991@gmail.com

Heba Abdel Ghfar, Professor

CONTACT

01005056590; hebaelshweety@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: August 5, 2025
• Primary Completion: February 14, 2026
• Study Completion: February 28, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

EG (1)