Pulsed Electromagnetic FieldNCT06662552
Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn
A study testing whole body vibration using crazy fit machine, Pulsed electromagnetic field therapy and traditional physical therapy program in people with Pulsed Electromagnetic Field and Whole Body Vibration, run by Cairo University at 1 site in Egypt.
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 years
- Conditions the study is for
- Pulsed Electromagnetic Field, Whole Body Vibration, Burns
- What is being tested?
- whole body vibration using crazy fit machine, Pulsed electromagnetic field therapy and traditional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2024to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Both sex.
- Their ages will be ranged from 25 to 40 years.
- Have second degree burn of 10 % to 25 %.
- Their body mass index (BMI) will not exceed 34.9 Kg/m2.
- All patients will be 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
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Giza
Aya Talaat Mustafa, physical therapist, 01112269937, drayatalaat@gmail.com
About this study
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
Severe burn is associated with excessive muscle wasting and atrophy. Muscle wasting is defined as unintentional weight loss of 5%- 10% of muscle mass, and severely burned patients are reported to lose up to 25% of total body mass acutely. (Dirks et al., 2016). These are worsened by deconditioning (eg, prolonged bed rest, immobilization, and inactivity). (Baker et al., 2007).
Furthermore, the need of this study is developed from the lack in the quantitative knowledge and information in the published studies about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn.
This study will be designed to provide a guideline about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn
- Conditions
- Pulsed Electromagnetic Field, Whole Body Vibration, Burns
- Being tested
- whole body vibration using crazy fit machine, Pulsed electromagnetic field therapy, traditional physical therapy program
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration using crazy fit machineDevice
It will be applied on the whole body All subjects will be asked to stand in a squat position on the vibration platform with the knees bent 90 this position will be chosen because the vertical sinusoidal accelerations of the vibration platform had to be damped by the different muscles around the joints of the lower extremity) ,at a frequency of 30 Hz, 5 - 30 minutes per day, 3 times per week, for 6 weeks, and the physiotherapist will be standing beside the patient
Pulsed electromagnetic field therapyDevice
EMSCULPT device (BTL Industries Inc., Boston, MA) based on HIFEM technology. It consists of an appliance, motorized bed and solenoids. The appliance will be connected to electrical mains supplying230Vat frequency of 50 or 60 Hz with earth connection, Intensity 0-100. It will be used in the treatment of patient in group "B". Subjects will be positioned in a supine position, and the treatment will be performed by placing the applicator centered over their thigh region (quadriceps muscle's area), for 15 minutes per day, 3 times per week for 6 weeks, the physiotherapist will be sitting beside the patient
traditional physical therapy programOther
In the form of splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises on quadriceps muscle 15 minutes per day, 3 times per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| whole body vibration group | Experimental | Fifteen patients will receive whole body vibration and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises) on quadriceps muscle (3 times per week, for 6 weeks), plus medical treatment Receives: Device: whole body vibration using crazy fit machine; Other: traditional physical therapy program |
| pulsed electromagnetic field (PEMF) group | Active comparator | Fifteen patients will receive pulsed electromagnetic field (PEMF) and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises) on quadriceps muscle (3 times per week, for 6 weeks), plus medical treatment. Receives: Device: Pulsed electromagnetic field therapy; Other: traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change on quadriceps muscle strength using hand-held dynamometer
The study involves a bolster positioning to ensure a 35° knee flexion angle, verified using a goniometer. Participants are instructed to maintain their knee in contact with the bolster, with the dominant leg flexed at the hip and knee to stabilize the pelvis. Hips and buttocks are kept flat on the couch, and knee contact is maintained to maintain the angle. Participants are asked to push maximally against the pad to straighten their leg from the knee.
Measured: at baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start5 Nov 2024 (estimated)
- Primary completion5 Apr 2025 (estimated)
- Study completion5 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulsed Electromagnetic FieldStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Talaat Moustafa Moustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662552
- Sponsor's protocol ID
- Aya-004833
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn
- ClinicalTrials.gov ID
- NCT06662552
- Acronym / sponsor ID
- Aya-004833
- Conditions
- Pulsed Electromagnetic Field, Whole Body Vibration, Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Nov 2024 (estimated)
- Primary completion
- 5 Apr 2025 (estimated)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Severe burn is associated with excessive muscle wasting and atrophy. Muscle wasting is defined as unintentional weight loss of 5%- 10% of muscle mass, and severely burned patients are reported to lose up to 25% of total body mass acutely. (Dirks et al., 2016). These are worsened by deconditioning (eg, prolonged bed rest, immobilization, and inactivity). (Baker et al., 2007).
Furthermore, the need of this study is developed from the lack in the quantitative knowledge and information in the published studies about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn.
This study will be designed to provide a guideline about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole body vibration group | Experimental | Device: whole body vibration using crazy fit machine, Other: traditional physical therapy programFifteen patients will receive whole body vibration and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises) on quadriceps muscle (3 times per week, for 6 weeks), plus medical treatment |
| pulsed electromagnetic field (PEMF) group | Active comparator | Device: Pulsed electromagnetic field therapy, Other: traditional physical therapy programFifteen patients will receive pulsed electromagnetic field (PEMF) and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises) on quadriceps muscle (3 times per week, for 6 weeks), plus medical treatment. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both sex.
- Their ages will be ranged from 25 to 40 years.
- Have second degree burn of 10 % to 25 %.
- Their body mass index (BMI) will not exceed 34.9 Kg/m2.
- All patients will be clinically and medically stable when attending the study.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibration using crazy fit machineIt will be applied on the whole body All subjects will be asked to stand in a squat position on the vibration platform with the knees bent 90 this position will be chosen because the vertical sinusoidal accelerations of the vibration platform had to be damped by the different muscles around the joints of the lower extremity) ,at a frequency of 30 Hz, 5 - 30 minutes per day, 3 times per week, for 6 weeks, and the physiotherapist will be standing beside the patient | Device | whole body vibration group |
| Pulsed electromagnetic field therapyEMSCULPT device (BTL Industries Inc., Boston, MA) based on HIFEM technology. It consists of an appliance, motorized bed and solenoids. The appliance will be connected to electrical mains supplying230Vat frequency of 50 or 60 Hz with earth connection, Intensity 0-100. It will be used in the treatment of patient in group "B". Subjects will be positioned in a supine position, and the treatment will be performed by placing the applicator centered over their thigh region (quadriceps muscle's area), for 15 minutes per day, 3 times per week for 6 weeks, the physiotherapist will be sitting beside the patient | Device | pulsed electromagnetic field (PEMF) group |
| traditional physical therapy programIn the form of splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises on quadriceps muscle 15 minutes per day, 3 times per week for 6 weeks. | Other | pulsed electromagnetic field (PEMF) group, whole body vibration group |
Primary outcome
Assessment of change on quadriceps muscle strength using hand-held dynamometer
Time frame: at baseline and after 6 weeks
The study involves a bolster positioning to ensure a 35° knee flexion angle, verified using a goniometer. Participants are instructed to maintain their knee in contact with the bolster, with the dominant leg flexed at the hip and knee to stabilize the pelvis. Hips and buttocks are kept flat on the couch, and knee contact is maintained to maintain the angle. Participants are asked to push maximally against the pad to straighten their leg from the knee.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration using crazy fit machine, Pulsed electromagnetic field therapy and traditional physical therapy program in people with Pulsed Electromagnetic Field and Whole Body Vibration, run by Cairo University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Talaat Mustafa, physical therapist (01112269937, drayatalaat7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change on quadriceps muscle strength using hand-held dynamometer (time frame: at baseline and after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2024.