- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06525103
PEMT Versus WBV on Quadriceps Strength Post Burn
October 6, 2024 updated by: Aya Talaat Moustafa Moustafa, Cairo University
Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn
The purpose of the study is to evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
A burn is an injury to the skin or other organic tissue primarily caused by heat, radiation or radioactivity, electricity, friction, or contact with chemicals.
It is the fourth most common type of trauma worldwide and a major cause of mortality and disability in developing countries.
Patients with ≥ 20% total burn surface area (TBSA) injury are potentially predisposed to significant morbidity and mortality.
The immobilization period after burn is accompanied by numerous detrimental effect namely sever deconditioning such as sever weakness, impaired motor control decrease cognitive status, pain, risk of graft shearing and psychological factors.
Severe burns are typically followed by a hypermetabolic response that lasts for at least 9-12 months post-injury.
The endocrine status is also markedly altered with an initial and then sustained increase in proinflammatory 'stress' hormones such as cortisol and other glucocorticoids, and catecholamines including epinephrine and norepinephrine by the adrenal medulla and cortex.
These hormones exert catabolic effects leading to muscle wasting .
Pulsed electromagnetic fields (PEMFs) are known to be a noninvasive, safe and effective therapy agent without apparent side effects.
Numerous studies have shown that PEMFs possess the potential to become a stand-alone or adjunctive treatment modality for treating musculoskeletal disorders.
There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulate mitochondrial activities for muscle gain.
PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing.
Whole Body Vibration Training (WBVT) can be described as exercising on a platform with an oscillating motion.
Whole Body Vibration (WBV) is a newly developed neuromuscular training method, in which vibrations of various frequencies are provided to mechanically stimulate the receptors in the body such as muscle spindles.
Whole Body Vibration Training (WBVT) elicits a biological adaptation that is connected to the neural potentiation effect.
In this effect the proprioceptive pathways are strongly stimulated by the vibration which results in reflexive muscle contractions.
Although WBVT combined with resistance training is becoming increasingly popular in various training recommendations, there is still an ongoing debate in literature, whether there are additional effects of WBV on muscle fitness and muscle performance in comparison to conventional exercise.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: aya talaat moustafa
- Phone Number: 01060480024
- Email: drayatalaat7@gmail.com
Study Contact Backup
- Name: hesham galal, PhD
- Phone Number: 01030792492
- Email: heshammahran75@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• Both sexes.
- Their ages were ranged from 25 to 40 years.
- Had second degree burn of 10 % to 25 %.
- Their body mass index (BMI) was not exceeded 34.9 Kg/m2.
- All patients were clinically and medically stable when attending the study
Exclusion Criteria:
• Unstable cardiovascular problems like arrhythmia and heart failure.
- Diabetes mellitus.
- Chronic chest disease.
- Patients on medications affecting muscle power as steroids.
- Auditory and visual problems.
- Pregnancy & lactation.
- Patients with history of epilepsy.
- Clinically significant peripheral vascular disease.
- Musculoskeletal or neurological limitation to physical exercise.
- Any cognitive impairment that interferes with prescribed exercise procedures.
- Amputation of lower limb.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group (A): Fifteen patients will receive whole body vibration
|
Crazy fit machine.
|
|
Experimental: Group (B): Fifteen patients will receive pulsed electromagnetic field (PEMF)
|
EMSCULPT device (BTL Industries Inc., Boston, MA) based on HIFEM technology.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measure the strengh of quadriceps
Time Frame: basline
|
evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn
|
basline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 18, 2024
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
July 2, 2024
First Submitted That Met QC Criteria
July 23, 2024
First Posted (Actual)
July 29, 2024
Study Record Updates
Last Update Posted (Actual)
October 8, 2024
Last Update Submitted That Met QC Criteria
October 6, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEMT VS WBV on Qadri
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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