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

Overview

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.

Interventions

• Other 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
• Device 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 wee

Primary outcome measures

• Penetration Aspiration Score (PAS) [Time frame: 18 weeks]
• Eating Assessment Tool (EAT)-10 [Time frame: 18 weeks]
• Functional Oral Intake Scale (FOIS): [Time frame: 18 weeks]
• Serum Creatinine/Cystatin C Ratio [Time frame: 18 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Mohamed Ahmed Mostafa — Cairo

Identifiers

NCT: NCT07100262 · P.T.REC/012/005715

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗