Whole-Body Vibration Training On Thermal Burn Injury In Pediatrics

NCT06116227 | Unknown DMC

• 1 other identifier: 24112004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Whole-Body Vibration Training; Thermal burn; Pediatrics.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postural Stability

  2 months.

• Functional Mobility

  2 months.

• Muscle Strength

  2 months.

Study Arms (2)

Group A: Whole Body Vibration Training plus conventional physical therapy exercise program

EXPERIMENTAL

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.

Device: Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program.; Other: Conventional Physical Therapy Exercise Program.

Group B: Conventional Physical Therapy Exercise Program.

EXPERIMENTAL

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.

Other: Conventional Physical Therapy Exercise Program.

Interventions

Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program. DEVICE

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.

Group A: Whole Body Vibration Training plus conventional physical therapy exercise program

Conventional Physical Therapy Exercise Program. OTHER

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.

Group A: Whole Body Vibration Training plus conventional physical therapy exercise program; Group B: Conventional Physical Therapy Exercise Program.

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age will range from 10 to 16 years
• Patients of both sexes.
• Participants have 25-40 % partial and full thickness burn of the lower limb and trunk.
• Participants with complete wound healing or after 35-58 days from the start day of the injury.

You may not qualify if:

• Patients with open burn wounds in any area of the body.
• Patients diagnosed with acute rheumatoid arthritis
• Diabetes, neuropathy, and neurological disorders.
• Severe behavioral cognitive disorders.
• Previous brain injury or any disease affecting balance, vestibular or visual disorders.
• Patients with a history of traumatic spine within the past six months.
• Patients with a prosthesis, Leg amputation, lower limb deformity, recent fracture or bone disease.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hadaya Mosaad Eladl

Cairo, 12322, Egypt

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Hadaya M Eladl

CONTACT

+201144814304; hd_mos@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD (Principal Investigator)

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: November 3, 2023
• Study Start: October 30, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 15, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months of Publication.

Locations

EG (1)