AzTrials
AzTrials

Burns of ThighNCT06525103

PEMT Versus WBV on Quadriceps Strength Post Burn

A study testing electromagnitic field therapy and whole body vibration in people with Burns of Thigh, run by Cairo University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Burns of Thigh
What is being tested?
electromagnitic field therapy and whole body vibration
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
18 Oct 2024to Dec 2024
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • 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

Who cannot join

  • • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

aya talaat moustafa contact

01060480024

drayatalaat7@gmail.com

hesham galal, PhD contact

01030792492

heshammahran75@yahoo.com

About this study

Official title: 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.

Read the 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.

Conditions
Burns of Thigh
Being tested
electromagnitic field therapy, whole body vibration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electromagnitic field therapyDevice

    EMSCULPT device (BTL Industries Inc., Boston, MA) based on HIFEM technology.

    • Frequency : 50 or 60 Hz.
    • Intenisty: 0-100 .Input voltage: 230 V
  • whole body vibrationDevice

    Crazy fit machine.

    • Input voltage:220 V.
    • Frequency : 30 Hz.
    • Maximum power: 1500W.
    • Intensity:1 to 50 levels.
Study groups in NCT06525103
Study groupRoleWhat they receive
Group (A): Fifteen patients will receive whole body vibrationExperimentalNot described
Receives: Device: whole body vibration
Group (B): Fifteen patients will receive pulsed electromagnetic field (PEMF)ExperimentalNot described
Receives: Device: electromagnitic field therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measure the strengh of quadriceps

    evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn

    Measured: basline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start18 Oct 2024 (estimated)
  3. Primary completionNov 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Thirty patients (male and female) who suffering from second degree burn with burned body surface area 10% \_25% BSA will participate in this study, they will be recruited from Al-Ahrar Teaching Hospital at Alsharqiya Governorate, Egypt. Their ages will be ranged from 25 to 40 years
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06525103
Sponsor's protocol ID
PEMT VS WBV on Qadri
Status last verified
Oct 2024
First submitted
2 Jul 2024
Last updated
8 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cheing GL, Li X, Huang L, Kwan RL, Cheung KK. Pulsed electromagnetic fields (PEMF) promote early wound healing and myofibroblast proliferation in diabetic rats. Bioelectromagnetics. 2014 Apr;35(3):161-9. doi: 10.1002/bem.21832. Epub 2014 Jan 3.

    PubMed 24395219

Questions about this trial

What is this clinical trial studying?

A study testing electromagnitic field therapy and whole body vibration in people with Burns of Thigh, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact aya talaat moustafa (01060480024, drayatalaat7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measure the strengh of quadriceps (time frame: basline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06525103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in