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

NCT06662552 | Not Yet Recruiting

• 1 other identifier: Aya-004833
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pulsed Electromagnetic Field; Whole Body Vibration; Burns

Outcome Measures

Primary Outcomes (1)

• Assessment of change on quadriceps muscle strength using hand-held dynamometer

  The study involves a bolster positioning to ensure a 35° knee flexion angle, verified using a goniometer. Participants are instructed to maintain their knee in contact with the bolster, with the dominant leg flexed at the hip and knee to stabilize the pelvis. Hips and buttocks are kept flat on the couch, and knee contact is maintained to maintain the angle. Participants are asked to push maximally against the pad to straighten their leg from the knee.

  at baseline and after 6 weeks

Study Arms (2)

whole body vibration group

EXPERIMENTAL

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

Device: whole body vibration using crazy fit machine; Other: traditional physical therapy program

pulsed electromagnetic field (PEMF) group

ACTIVE COMPARATOR

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.

Device: Pulsed electromagnetic field therapy; Other: traditional physical therapy program

Interventions

whole body vibration using crazy fit machine 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

whole body vibration group

Pulsed electromagnetic field therapy 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

pulsed electromagnetic field (PEMF) group

traditional physical therapy program 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; whole body vibration group

Eligibility Criteria

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

You may qualify if:

• Both sex.
• Their ages will be ranged from 25 to 40 years.
• Have second degree burn of 10 % to 25 %.
• Their body mass index (BMI) will not exceed 34.9 Kg/m2.
• All patients will be clinically and medically stable when attending the study.

You may not qualify if:

• Unstable cardiovascular problems like arrhythmia and heart failure.
• Diabetes mellitus.
• Chronic chest disease.
• Patients on medications affecting muscle power as steroids.
• Auditory and visual problems.
• Pregnancy \& lactation.
• Patients with history of epilepsy.
• Clinically significant peripheral vascular disease.
• Musculoskeletal or neurological limitation to physical exercise.
• Any cognitive impairment that interferes with prescribed exercise procedures.
• Amputation of lower limb.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Giza, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Aya Talaat Mustafa, physical therapist

CONTACT

01112269937; drayatalaat7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 29, 2024
• Study Start: November 5, 2024
• Primary Completion: April 5, 2025
• Study Completion: May 5, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

EG (1)