BurnsNCT06116227
Whole-Body Vibration Training On Thermal Burn Injury In Pediatrics
A study testing Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program. and Conventional Physical Therapy Exercise Program. in people with Burns, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Burns
- What is being tested?
- Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program. and Conventional Physical Therapy Exercise Program.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Whole-Body Vibration Training on Thermal Burn Injury in Paediatrics: A Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Burns
- Being tested
- Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program., Conventional Physical Therapy Exercise Program.
- Keywords
- Whole-Body Vibration Training, Thermal burn, Pediatrics.
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physical Therapy Exercise Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 momths
Secondary outcomes (3)
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).
Measured: 2 months.
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.
Measured: 2 months.
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.
Measured: 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start30 Oct 2023
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadaya Mosaad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116227
- Sponsor's protocol ID
- 24112004
- Status last verified
- Jun 2026
- First submitted
- 21 Oct 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After 6 months of Publication, we can share the study protocol and Informed Consent form.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Whole-Body Vibration Training on Thermal Burn Injury in Paediatrics: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06116227
- Acronym / sponsor ID
- 24112004
- Conditions
- Burns
- Keywords
- Whole-Body Vibration Training, Thermal burn, Pediatrics.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Whole Body Vibration Training plus conventional physical therapy exercise program | Experimental | Device: Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program., Other: 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. | Experimental | Other: 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group A: Whole Body Vibration Training plus conventional physical therapy exercise program |
| 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. | Other | Group A: Whole Body Vibration Training plus conventional physical therapy exercise program, Group B: Conventional Physical Therapy Exercise Program. |
Primary outcome
Balance Control:
Time frame: 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.
3 secondary outcomes
Postural Stability
Time frame: 2 months.
Functional Mobility
Time frame: 2 months.
Muscle Strength
Time frame: 2 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. After 6 months of Publication, we can share the study protocol and Informed Consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program. and Conventional Physical Therapy Exercise Program. in people with Burns, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Control: (time frame: 2 momths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.