Clinical trial NCT06116227: Whole-Body Vibration Training On Thermal Burn Injury In Pediatrics
Official title: Efficacy of Whole-Body Vibration Training on Thermal Burn Injury in Paediatrics: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Keywords: Whole-Body Vibration Training
Thermal burn
Pediatrics.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Balance Control:
timeFrame: 2 momths
Secondary outcomes:
measure: Postural Stability
timeFrame: 2 months.
measure: Functional Mobility
timeFrame: 2 months.
measure: Muscle Strength
timeFrame: 2 months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hadaya Mosaad Eladl
Study officials:
References: