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

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 .

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Burn
• Intervention / Treatment: Device: pulsed electromagnetic field device; Other: Free weights for Strengthening Exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walaa A Abd Elaziz, master; Phone Number: 020 01099386825; Email: walaaamr106@gmail.com

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12613
      • Recruiting
      • Cairo University
      • Contact: Walaa A Abd Elaziz, master; Phone Number: 020 01099386825; Email: walaaamr106@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other: 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
Active Comparator: 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)	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Collaborators and Investigators

• Sponsor: Walaa Abd Elaziem Abd Elaziz
• Investigators: Principal Investigator: Walaa A Elaziz, master, lecturer assistant at faculty of physical therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2021
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: P.T.REC/012/002906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No