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

NCT04870528 | Unknown

• 1 other identifier: P.T.REC/012/002906
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

Lower Limb Burn

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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)

Other: Free weights for Strengthening Exercise

Interventions

pulsed electromagnetic field device 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.

Experimental group

Free weights for Strengthening Exercise 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

Experimental group; control group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Walaa Abd Elaziem Abd Elaziz: lead

Study Sites (1)

Cairo University

Dokki, Giza Governorate, 12613, Egypt

RECRUITING

Study Officials

• Walaa A Elaziz, master

  lecturer assistant at faculty of physical therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walaa A Abd Elaziz, master

CONTACT

01099386825; walaaamr106@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of physical therapy, Cairo University

Model Details: 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).

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: April 25, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 30, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)