Lower Limb BurnNCT04870528
Adjunctive Effect of Pulsed Electromagnetic Field on Quadriceps Muscle Strength After Burn Injury
A study testing pulsed electromagnetic field device and Free weights for Strengthening Exercise in people with Lower Limb Burn, run by Walaa Abd Elaziem Abd Elaziz at 1 site in Egypt.
Trial summary
The aim of this study is to examine whether Pulsed Electromagnetic Field therapy combined with strengthening exercises will have a positive effect on quadriceps muscle strength in lower limb burn . Read more about this study
- Who is it for?
- Ages 25 to 40 years, men only
- Conditions the study is for
- Lower Limb Burn
- What is being tested?
- pulsed electromagnetic field device and Free weights for Strengthening Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2021to 30 May 2022
- 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- - Patients are males.
- Their age will range from (25-40) years.
- Patients will suffer from second-degree burn ( Partial thickness of thermal injury).
- Total body surface area (TBSA) for the burns will be ranged from 20% to 35% .
- They will be selected from Outpatient Clinic of Faculty of Physical Therapy and Burn Unit at Om El-Obour Hospital.
- Patients will begin the training program after complete wound healing.
- All patients will receive traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living.
- Patients will be given their informed consent.
Who cannot join
- - Patients who participate in any rehabilitation program to improve muscle strength prior to the study.
- Musculoskeletal disorders that will impair performance during training and tests.
- Equilibrium disorders.
- Uncontrolled cardiovascular or pulmonary diseases .
- Neurological and renal disorders.
- metabolic or vascular disease with a neurological component such as diabetes,
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- Malignant conditions.
- Psychiatric illness, severe behavior or cognitive disorders.
- Subjects with burn to the posterior thigh with knee flexion contracture, which affected the function of the quadriceps muscle.
- Lower limb lymphedema or lipoedema.
- Athletic subjects.
- Subjects with morbid obesity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Dokki, Giza Governorate, 12613
Walaa A Abd Elaziz, master, 01099386825 ext. 020, walaaamr106@gmail.com
About this study
The aim of this study is to examine whether Pulsed Electromagnetic Field therapy combined with strengthening exercises will have a positive effect on quadriceps muscle strength in lower limb burn .
Read the detailed description
- Subjects: Sixty patients with lower limb burn, subdivided into two groups each one has 30 patients.
- Group (A) = Pulsed Electromagnetic Field therapy and quadriceps strengthening exercises group.
- Group (B) = quadriceps strengthening exercises group. • Equipment and tools:
- Measurements tools: Isokinetic dynamometer : to measure the quadriceps muscle peak torque before the treatment and after 8 weeks of treatment for both groups.
- Therapeutic tools:
Pulsed Electromagnetic Field therapy device and free weights for strengthening of quadriceps muscle.
- Conditions
- Lower Limb Burn
- Being tested
- pulsed electromagnetic field device, Free weights for Strengthening Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed electromagnetic field deviceDevice
the pulsed electromagnetic field device treatment parameters will be set as 15 Hz frequency, 20 gauss amplitude, and 20 minutes as total treatment duration.
Free weights for Strengthening ExerciseOther
- Parameters of the exercise program: Intensity : The weight or load the patients lifted is set at 50-60% of their individual 1RM , 3 sets of 10 repetitions during the first week. During the second week, the lifting load is increased to 70-75% (3 sets of 10 repetitions) of their individual 1RM and continued for weeks 2-6. After this, training intensity is increased to 80-85% of the 1 RM and implemented from weeks 7-8.
Frequency: 3 sessions per week for 8 weeks. Number of repetitions: 3 sets,10 repetitions in each set. Total treatment duration: 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | - This group will be composed of 30 patients with lower limb burn of second-degree. Subjects will receive pulsed magnetic field over thigh areas for 24 sessions over a period of 8 weeks (3sessions/week) with receiving strengthening exercises for quadriceps muscle and traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living. Receives: Device: pulsed electromagnetic field device; Other: Free weights for Strengthening Exercise |
| control group | Active comparator | Subjects will receive strengthening exercises for quadriceps muscle and traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living for 24 sessions over a period of 8 weeks (3sessions/week) Receives: Other: Free weights for Strengthening Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic dynamometer for measuring The peak torque of the quadriceps muscle
- Patients will warm up for 5 min on a cycle ergometer then quadriceps, hamstrings and calf muscles will be stretched 3 times with a 30 seconds stretch and a 30 seconds rest.
- Patients will be positioned in an isokinetic dynamometer. The measurements are carried out with the backrest reclined 5° from vertical and knees flexed 90 degrees and straps fixing the trunk, waist and distal thigh. The rotation axis of the dynamometer is aligned with the axis of the knee joint at the level of the lateral epicondyle of the femur while it is attached to the distal part of the leg about 5cm above the medial malleolus and isokinetic test is performed at angular velocity of 150 degree per second.
- For familiarization, Patients will perform a series of three submaximal contractions. After warming up, subjects are requested to perform ten maximal voluntary contractions consecutively without rest in between.
- There will be three minutes of resting before repeating the test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start25 Apr 2021
- Primary completion15 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb BurnStudies of the same condition, open and under way.
- 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
- Model description
- In this study, the patients will be assigned into two equal groups : study group which will receive (Pulsed Electromagnetic Field therapy and quadriceps strengthening exercises), control group which will receive (Quadriceps strengthening exercises).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walaa Abd Elaziem Abd Elaziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walaa Abd Elaziem Abd Elaziz, Cairo University
- Investigators
- Walaa A Elaziz, master, Principal investigator, lecturer assistant at faculty of physical therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870528
- Sponsor's protocol ID
- P.T.REC/012/002906
- Status last verified
- Mar 2022
- First submitted
- 27 Apr 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Effect of Pulsed Electromagnetic Field on Quadriceps Muscle Strength After Burn Injury
- ClinicalTrials.gov ID
- NCT04870528
- Acronym / sponsor ID
- P.T.REC/012/002906
- Conditions
- Lower Limb Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Walaa Abd Elaziem Abd ElazizUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 3 May 2021 (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 aim of this study is to examine whether Pulsed Electromagnetic Field therapy combined with strengthening exercises will have a positive effect on quadriceps muscle strength in lower limb burn .
Detailed description
- Subjects: Sixty patients with lower limb burn, subdivided into two groups each one has 30 patients.
- Group (A) = Pulsed Electromagnetic Field therapy and quadriceps strengthening exercises group.
- Group (B) = quadriceps strengthening exercises group. • Equipment and tools:
- Measurements tools: Isokinetic dynamometer : to measure the quadriceps muscle peak torque before the treatment and after 8 weeks of treatment for both groups.
- Therapeutic tools:
Pulsed Electromagnetic Field therapy device and free weights for strengthening of quadriceps muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In this study, the patients will be assigned into two equal groups : study group which will receive (Pulsed Electromagnetic Field therapy and quadriceps strengthening exercises), control group which will receive (Quadriceps strengthening exercises).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: pulsed electromagnetic field device, Other: Free weights for Strengthening Exercise- This group will be composed of 30 patients with lower limb burn of second-degree. Subjects will receive pulsed magnetic field over thigh areas for 24 sessions over a period of 8 weeks (3sessions/week) with receiving strengthening exercises for quadriceps muscle and traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living. |
| control group | Active comparator | Other: Free weights for Strengthening ExerciseSubjects will receive strengthening exercises for quadriceps muscle and traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living for 24 sessions over a period of 8 weeks (3sessions/week) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- - Patients are males.
- Their age will range from (25-40) years.
- Patients will suffer from second-degree burn ( Partial thickness of thermal injury).
- Total body surface area (TBSA) for the burns will be ranged from 20% to 35% .
- They will be selected from Outpatient Clinic of Faculty of Physical Therapy and Burn Unit at Om El-Obour Hospital.
Key exclusion criteria (12 listed)
- - Patients who participate in any rehabilitation program to improve muscle strength prior to the study.
- Musculoskeletal disorders that will impair performance during training and tests.
- Equilibrium disorders.
- Uncontrolled cardiovascular or pulmonary diseases .
- Neurological and renal disorders.
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 |
|---|---|---|
| pulsed electromagnetic field devicethe pulsed electromagnetic field device treatment parameters will be set as 15 Hz frequency, 20 gauss amplitude, and 20 minutes as total treatment duration. | Device | Experimental group |
| Free weights for Strengthening Exercise• Parameters of the exercise program: Intensity : The weight or load the patients lifted is set at 50-60% of their individual 1RM , 3 sets of 10 repetitions during the first week. During the second week, the lifting load is increased to 70-75% (3 sets of 10 repetitions) of their individual 1RM and continued for weeks 2-6. After this, training intensity is increased to 80-85% of the 1 RM and implemented from weeks 7-8. Frequency: 3 sessions per week for 8 weeks. Number of repetitions: 3 sets,10 repetitions in each set. Total treatment duration: 8 weeks | Other | Experimental group, control group |
Primary outcome
Isokinetic dynamometer for measuring The peak torque of the quadriceps muscle
Time frame: 8 weeks
* Patients will warm up for 5 min on a cycle ergometer then quadriceps, hamstrings and calf muscles will be stretched 3 times with a 30 seconds stretch and a 30 seconds rest. * Patients will be positioned in an isokinetic dynamometer. The measurements are carried out with the backrest reclined 5° from vertical and knees flexed 90 degrees and straps fixing the trunk, waist and distal thigh. The rotation axis of the dynamometer is aligned with the axis of the knee joint at the level of the lateral epicondyle of the femur while it is attached to the distal part of the leg about 5cm above the medial malleolus and isokinetic test is performed at angular velocity of 150 degree per second. * For familiarization, Patients will perform a series of three submaximal contractions. After warming up, subjects are requested to perform ten maximal voluntary contractions consecutively without rest in between. * There will be three minutes of resting before repeating the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Walaa A Elaziz, master principal investigator
lecturer assistant at faculty of physical therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed electromagnetic field device and Free weights for Strengthening Exercise in people with Lower Limb Burn, run by Walaa Abd Elaziem Abd Elaziz 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 8 inclusion and 12 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 17 Mar 2022. 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 Walaa A Abd Elaziz, master (01099386825 ext. 020, walaaamr106@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic dynamometer for measuring The peak torque of the quadriceps muscle (time frame: 8 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 17 Mar 2022.