Whole-Body Vibration Training On Thermal Burn Injury In Pediatrics

Not Applicable

Recruiting

• Conditions: Burns
• Interventions: Device: Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program.; Other: Conventional Physical Therapy Exercise Program.

• Registration Number: NCT06116227
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-21
• Study Start: 2023-10-30
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-07-30
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Whole Body Vibration Training plus conventional physical therapy exercise program	Conventional Physical Therapy Exercise Program.	30 patients received whole body vibration training on a vibration platform for 12-15 minutes, 3 times per week, plus a traditional physical therapy exercise program in the form of a 60-minute supervised exercise program for 8 weeks.
Group B: Conventional Physical Therapy Exercise Program.	Conventional Physical Therapy Exercise Program.	30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised exercise stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.
Group A: Whole Body Vibration Training plus conventional physical therapy exercise program	Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program.	30 patients received whole body vibration training on a vibration platform for 12-15 minutes, 3 times per week, plus a traditional physical therapy exercise program in the form of a 60-minute supervised exercise program for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Balance Control:	2 momths	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.

Secondary Outcome Measures

Name	Time	Method
Postural Stability	2 months.	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).
Muscle Strength	2 months.	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.
Functional Mobility	2 months.	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.

Trial Locations

Locations (1)

Hadaya Mosaad Eladl; 🇪🇬 Cairo, Egypt