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

Primary Purpose

Lower Limb Burn

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulsed electromagnetic field device
Free weights for Strengthening Exercise
Sponsored by
Walaa Abd Elaziem Abd Elaziz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Burn

Eligibility Criteria

25 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

control group

Arm Description

- 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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
March 15, 2022
Sponsor
Walaa Abd Elaziem Abd Elaziz
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1. Study Identification

Unique Protocol Identification Number
NCT04870528
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Walaa Abd Elaziem Abd Elaziz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
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).
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
- 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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
pulsed electromagnetic field device
Intervention Description
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
Other
Intervention Name(s)
Free weights for Strengthening Exercise
Intervention Description
• 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
Primary Outcome Measure Information:
Title
Isokinetic dynamometer for measuring The peak torque of the quadriceps muscle
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa A Abd Elaziz, master
Phone
01099386825
Ext
020
Email
walaaamr106@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walaa A Elaziz, master
Organizational Affiliation
lecturer assistant at faculty of physical therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Dokki
State/Province
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walaa A Abd Elaziz, master
Phone
01099386825
Ext
020
Email
walaaamr106@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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