Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn

NCT ID: NCT06662552

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2025-05-05

Brief Summary

The purpose of the study is to evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn

Detailed Description

Severe burn is associated with excessive muscle wasting and atrophy. Muscle wasting is defined as unintentional weight loss of 5%- 10% of muscle mass, and severely burned patients are reported to lose up to 25% of total body mass acutely. (Dirks et al., 2016). These are worsened by deconditioning (eg, prolonged bed rest, immobilization, and inactivity). (Baker et al., 2007).

Furthermore, the need of this study is developed from the lack in the quantitative knowledge and information in the published studies about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn.

This study will be designed to provide a guideline about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn

Conditions

Pulsed Electromagnetic Field; Whole Body Vibration; Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

whole body vibration group

Fifteen patients will receive whole body vibration and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises) on quadriceps muscle (3 times per week, for 6 weeks), plus medical treatment

Group Type: EXPERIMENTAL

whole body vibration using crazy fit machine

Intervention Type: DEVICE

It will be applied on the whole body All subjects will be asked to stand in a squat position on the vibration platform with the knees bent 90 this position will be chosen because the vertical sinusoidal accelerations of the vibration platform had to be damped by the different muscles around the joints of the lower extremity) ,at a frequency of 30 Hz, 5 - 30 minutes per day, 3 times per week, for 6 weeks, and the physiotherapist will be standing beside the patient

traditional physical therapy program

Intervention Type: OTHER

In the form of splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises on quadriceps muscle 15 minutes per day, 3 times per week for 6 weeks.

pulsed electromagnetic field (PEMF) group

Fifteen patients will receive pulsed electromagnetic field (PEMF) and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises) on quadriceps muscle (3 times per week, for 6 weeks), plus medical treatment.

Group Type: ACTIVE_COMPARATOR

Pulsed electromagnetic field therapy

Intervention Type: DEVICE

EMSCULPT device (BTL Industries Inc., Boston, MA) based on HIFEM technology. It consists of an appliance, motorized bed and solenoids. The appliance will be connected to electrical mains supplying230Vat frequency of 50 or 60 Hz with earth connection, Intensity 0-100. It will be used in the treatment of patient in group "B". Subjects will be positioned in a supine position, and the treatment will be performed by placing the applicator centered over their thigh region (quadriceps muscle's area), for 15 minutes per day, 3 times per week for 6 weeks, the physiotherapist will be sitting beside the patient

traditional physical therapy program

Intervention Type: OTHER

In the form of splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises on quadriceps muscle 15 minutes per day, 3 times per week for 6 weeks.

Interventions

whole body vibration using crazy fit machine

It will be applied on the whole body All subjects will be asked to stand in a squat position on the vibration platform with the knees bent 90 this position will be chosen because the vertical sinusoidal accelerations of the vibration platform had to be damped by the different muscles around the joints of the lower extremity) ,at a frequency of 30 Hz, 5 - 30 minutes per day, 3 times per week, for 6 weeks, and the physiotherapist will be standing beside the patient

Intervention Type: DEVICE

Pulsed electromagnetic field therapy

EMSCULPT device (BTL Industries Inc., Boston, MA) based on HIFEM technology. It consists of an appliance, motorized bed and solenoids. The appliance will be connected to electrical mains supplying230Vat frequency of 50 or 60 Hz with earth connection, Intensity 0-100. It will be used in the treatment of patient in group "B". Subjects will be positioned in a supine position, and the treatment will be performed by placing the applicator centered over their thigh region (quadriceps muscle's area), for 15 minutes per day, 3 times per week for 6 weeks, the physiotherapist will be sitting beside the patient

Intervention Type: DEVICE

traditional physical therapy program

In the form of splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises on quadriceps muscle 15 minutes per day, 3 times per week for 6 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Both sex.

2. Their ages will be ranged from 25 to 40 years.

3. Have second degree burn of 10 % to 25 %.

4. Their body mass index (BMI) will not exceed 34.9 Kg/m2.

5. All patients will be clinically and medically stable when attending the study.

Exclusion Criteria

1. Unstable cardiovascular problems like arrhythmia and heart failure.

2. Diabetes mellitus.

3. Chronic chest disease.

4. Patients on medications affecting muscle power as steroids.

5. Auditory and visual problems.

6. Pregnancy & lactation.

7. Patients with history of epilepsy.

8. Clinically significant peripheral vascular disease.

9. Musculoskeletal or neurological limitation to physical exercise.

10. Any cognitive impairment that interferes with prescribed exercise procedures.

11. Amputation of lower limb.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Talaat Moustafa Moustafa

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

out-patient clinic, faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Central Contacts

Aya Talaat Mustafa, physical therapist

Role: CONTACT

drayatalaat7@gmail.com

01112269937

Facility Contacts

Aya Talaat Mustafa, physical therapist

Role: primary

drayatalaat@gmail.com

01112269937

Other Identifiers

Aya-004833

Identifier Type: -

Identifier Source: org_study_id