Whole-Body Vibration Training On Thermal Burn Injury In Pediatrics

Burns Clinical Trial

Official title:

Efficacy of Whole-Body Vibration Training on Thermal Burn Injury in Paediatrics: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116227
• Other study ID #: 24112004
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: Hadaya M Eladl
• Phone: +201144814304
• Email: hd_mos[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

60 Patients with partial and full thickness thermal burns of the lower limb and trunk will be indiscriminately assigned to study group Group A(Study group): 30 patients received whole body vibration training on a vibration platform 12-15 minutes, 5 times per week, plus traditional physical therapy exercise program in the form of 60 minutes supervised exercise program for 8 weeks.

Group B (control group):30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.

Description:

The sample of participants will be chosen from the pediatric burn population by random generator and allocated randomly into two groups by permuted block randomization. Group (A): 30 patients received whole body vibration training on a vibration platform, the frequency, amplitude, and duration utilized in this investigation will be as follows: frequency: 30-40 Hz, 2-4 mm of peak-to-peak vertical plate displacement, and exercise durations ranging from 12-15 minutes. Participants will perform 2 vibration exercises 5 times per week for 8 weeks. The first vibration exercise, a warm-up and familiarization set, will consist of sitting in a chair with both legs on the platform and performing one repetition, which will last 3 minutes. At the completion of the 3-minute warm-up set, participants will perform 3 sets of 3-minute semi-squats on the vibration platform. Vibration exercise time will be increased by 30 seconds each week, with 3 minutes of rest being given between repetitions. The participants will be barefooted and wear similar cotton socks for each vibration session. Maintaining an upright body position, stand on their forefoot with their heels off the ground and the knee joints flexed at an angle of 10u. Their head and eyes were forward and distributed their weight equally on both feet with a foot-to-foot distance of 42 cm. Plus traditional physical therapy exercise programs in 60-minute supervised exercise programs.

Group (B): 30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 15, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Age will range from 10 to 16 years

2. Patients of both sexes.

3. Participants have 25-40 % partial and full thickness burn of the lower limb and trunk.

4. Participants with complete wound healing or after 35-58 days from the start day of the injury.

Exclusion Criteria:

1. Patients with open burn wounds in any area of the body.

2. Patients diagnosed with acute rheumatoid arthritis

3. Diabetes, neuropathy, and neurological disorders.

4. Severe behavioral cognitive disorders.

5. Previous brain injury or any disease affecting balance, vestibular or visual disorders.

6. Patients with a history of traumatic spine within the past six months.

7. Patients with a prosthesis, Leg amputation, lower limb deformity, recent fracture or bone disease.

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program.
Patients in the study group will receive the traditional physical therapy program first, followed immediately by whole-body vibration training on the vibration platform (Power Plate International, Irvine, California, USA) at the same visit. The vibration frequency will be 30 Hz and the amplitude will be from 4 to 7 mm, with an increase of 1mm every two weeks. The WBV program was three sessions a week for eight weeks. WBV duration starts with 10 min in the 1st week and up to 25 min in the 8th week, with a regular increase of five minutes after every two successive weeks.

Other:
• Conventional Physical Therapy Exercise Program.
The program will include 60 minutes of a supervised and individualized exercise program, including stretching exercises for the Calf and hamstring muscles, followed by strengthening exercises for hip, knee, ankle, and foot muscles, and scar management techniques to avoid scar or contracture formation.

Locations

Country	Name	City	State
Egypt	Hadaya Mosaad Eladl	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance Control:	Biodex balance scale (Biodex medical systems Inc, Shirley, New York, USA), will be used for balance assessment that include overall stability index that is used to assess fluctuations around the zero point representing standard deviations rather than around a group mean. The overall stability index measures the fluctuations from the horizontal along axes of the Biodex stability system.	2 momths
Secondary	Postural Stability	The Berg balance scale includes 14 items with scores from 0 to 4. A score of 0 represents the inability to do the task, while a score of 4 represents the ability to do the task completely, according to the assigned criteria, with 56 indicates the total score. Items range from tasks of simple mobility(e.g. transfers, standing unsupported, sit-to-stand) to tasks with greater difficulty (e.g. tandem standing, turning 360°, single-leg stance).	2 months.
Secondary	Functional Mobility	Timed-up and go test will be used. The test asks the participant to raise up from the sitting position followed by walking for 3 m, turning around, sitting again on the chair with his back supported, and resting his arms on the armrests.	2 months.
Secondary	Muscle Strength	Muscle strength of the quadriceps and hamstring muscles will be assessed using a Biodex System-3 dynamometer (Biodex Medical System, Shirley, NY) prior to and following the 8-weeks intervention.	2 months.