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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Dysphagia

Treatments

Device: Pulsed electromagnetic therapy
Other: Effortful swallow exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07100262
P.T.REC/012/005715

Details and patient eligibility

About

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

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

66 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Effortful swallow exercise
Active Comparator group
Description:
The participants will receive two 30-minutes sessions of effortful swallow practice daily, 5 days/week, for 18 weeks.
Treatment:
Other: Effortful swallow exercise
Pulsed electromagnetic therapy and effortful swallow exercise
Experimental group
Description:
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.
Treatment:
Other: Effortful swallow exercise
Device: Pulsed electromagnetic therapy

Trial contacts and locations

1

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Central trial contact

Mohamed Mostafa, PHD; Heba Abdel Ghfar, Professor

Data sourced from clinicaltrials.gov

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