Adjunctive Effect of Pulsed Electromagnetic Field on Quadriceps Muscle Strength After Burn Injury

NCT ID: NCT04870528

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-25

Study Completion Date

2022-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

• 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:

1. Measurements tools:

Isokinetic dynamometer : to measure the quadriceps muscle peak torque before the treatment and after 8 weeks of treatment for both groups.
2. Therapeutic tools:

Pulsed Electromagnetic Field therapy device and free weights for strengthening of quadriceps muscle.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Limb Burn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The participants are suffering from lower limb burn with second-degree burn ( Partial thickness of thermal injury) and total body surface area (TBSA) from 20% to 35%.The care provider are burn center stuff. The investigator is a physical therapist(myself).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

\- 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.

Group Type EXPERIMENTAL

pulsed electromagnetic field device

Intervention Type DEVICE

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 Exercise

Intervention Type OTHER

• 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

control group

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)

Group Type ACTIVE_COMPARATOR

Free weights for Strengthening Exercise

Intervention Type OTHER

• 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pulsed electromagnetic field device

the pulsed electromagnetic field device treatment parameters will be set as 15 Hz frequency, 20 gauss amplitude, and 20 minutes as total treatment duration.

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \- 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.

Exclusion Criteria

* \- 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,
* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Walaa Abd Elaziem Abd Elaziz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Walaa Abd Elaziem Abd Elaziz

Assistant lecturer of physical therapy, Cairo University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Walaa A Elaziz, master

Role: PRINCIPAL_INVESTIGATOR

lecturer assistant at faculty of physical therapy, Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Dokki, Giza Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Walaa A Abd Elaziz, master

Role: CONTACT

01099386825 ext. 020

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Walaa A Abd Elaziz, master

Role: primary

01099386825 ext. 020

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T.REC/012/002906

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.