Clinical trial NCT04870528: Adjunctive Effect of Pulsed Electromagnetic Field on Quadriceps Muscle Strength After Burn Injury
Official title: Adjunctive Effect of Pulsed Electromagnetic Field on Quadriceps Muscle Strength After Burn Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb Burn
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 60
Sex: MALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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 .

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:

  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.

Eligibility criteria: 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.

Primary outcomes:
measure: Isokinetic dynamometer for measuring The peak torque of the quadriceps muscle
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: lecturer assistant at faculty of physical therapy, Cairo University
name: Walaa A Elaziz, master
role: PRINCIPAL_INVESTIGATOR
References: