Lower Extremity BurnsNCT06787716
Impact of Whole-body Vibration Training on Flexibility, Muscular Activity and Quality of Life After Lower Extremity Thermal Burn Injury
A study testing The whole body vibration and The traditional physical therapy program in people with Lower Extremity Burns, run by Cairo University at 1 site in Egypt.
Trial summary
Tight hamstring muscles limit the anterior tilt of the pelvis in spinal flexion resulting in aggravated muscle and ligamentous tension in the lumbar region which leads to significantly higher compressive loads on the lumbar spine. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Lower Extremity Burns
- What is being tested?
- The whole body vibration and The traditional physical therapy 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
- 20 Jan 2025to 1 Nov 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a deep second-degree thermal burn of the lower extremity, 35%-40% total body surface area (TBSA) of burn as measured with the rule of nine, after six weeks from the injury or complete wound healing.
- Patients with 20 to 50 years old.
- Absence of any neurological disorder i.e.: stroke, ataxia, or parkinsonism.
Who cannot join
- Patients with open wounds.
- Patients with recent fractures.
- Patients with severe obesity BMI ≥40.
- Patients with cardiorespiratory disorders.
- Patients with bone disease, joint replacement, and traumatic spine history since last year.
- In order to apply the inclusion and exclusion criteria, all cases will be subjected to an interview and assessment.
- Those subjects who will be eligible to take part in the study will sign an informed consent before participation in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Cairo, Giza Governorate
About this study
Tight hamstring muscles limit the anterior tilt of the pelvis in spinal flexion resulting in aggravated muscle and ligamentous tension in the lumbar region which leads to significantly higher compressive loads on the lumbar spine. Other postural changes associated with tightness of the hamstrings can influence the sacroiliac joint stability in an indirect way. Hence, flexibility of hamstring muscles is crucial for overall well-being and optimal physical fitness.
- Conditions
- Lower Extremity Burns
- Being tested
- The whole body vibration, The traditional physical therapy program
- Keywords
- burn, flexibility, EMG, muscular activity, quality of life
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The whole body vibrationDevice
Patients in the study group will receive the traditional physical therapy program first (passive and active ROM exercises, stretching and strengthening exercises) for 60 minutes, 3 days/ week for 12 weeks.This will be 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 from 4 to 7 mm, with an increase of 1mm every two weeks. The WBV program will be three sessions a week for 12 weeks. WBV duration started with 10 min at the 1st week up to 35 min at the 12th week, with a regular increase of five minutes every two successive weeks.
The traditional physical therapy programOther
The traditional physical therapy program will be three days a week for 12 weeks. The program will include 60 minutes of a supervised and individualized exercise program including passive and active exercises of the hip, knee, and ankle joints, stretching exercises for the Calf and hamstring muscles followed by strengthening exercises of the hip, knee, ankle, and foot muscles. To improve the strength, free weights will be used for all exercises. During the first week, 50 to 60% of the repetitions maximum test will be set as the starting weight. Then, from the second week to the sixth, the weight will be increased to 70%-75% of three repetitions maximum (3 sets, 4-10 repetitions). The training amplitude then will be raised to 80%-85% of the three-repetition maximum (3 sets, 8-12 repetitions) that will be continued through weeks 7 to 12, holding 5 seconds at the end of the range.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration group | Experimental | Not described Receives: Device: The whole body vibration |
| Control group | Other | Not described Receives: Other: The traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Knee Extension Test:
Active knee extension test: The knee extension angle was measured using a standard goniometer. The goniometer was placed at the lateral epicondyle of the femur, with one arm aligned with the femur and the other with the tibia.
Measured: 12 weeks
Secondary outcomes (4)
Straight Leg Raising Test
The straight leg raising test will be used to determine the hip flexion angle by using a standard goniometer. The fixed arm will be parallel to the table, while the other will point to the lateral femoral condyle and malleolus. At the point of discomfort, the goniometer will be oriented with the movable arm toward the lateral malleolus.
Measured: 12 weeks
Electromyography for Quadriceps Muscle
Electromyography will be used to assess the activity of the following muscles at baseline then at the end of the 12 weeks intervention: Vastus medialis, vastus lateralis and rectus femoris.
Measured: 12 weeks
Electromyography for Hamstring Muscles
Electromyography will be used to assess the activity of the following muscles at baseline then at the end of the 12 weeks intervention: Biceps femoris and medial hamstrings.
Measured: 12 weeks
The SF-36 questionnaire
SF-36 is a health related quality of life measure with 35 of the items related to one of the 8 health concepts. One item addresses health transition and is not included in the scoring. The health concepts measured include physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
The SF-36 Subscales (Each scored 0-100)
- Physical Functioning (PF)
- Role Limitations - Physical (RP)
- Bodily Pain (BP)
- General Health (GH)
- Vitality (VT)
- Social Functioning (SF)
- Role Limitations - Emotional (RE)
- Mental Health (MH)
Interpretation:
0 = Worst possible health status for that domain 100 = Best possible health status for that domain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start20 Jan 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rokaia Ali Zainelabedeen Mohamed Toson, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787716
- Sponsor's protocol ID
- P.T.REC/012/005595
- Status last verified
- Nov 2025
- First submitted
- 26 Dec 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Whole-body Vibration Training on Flexibility, Muscular Activity and Quality of Life After Lower Extremity Thermal Burn Injury
- ClinicalTrials.gov ID
- NCT06787716
- Acronym / sponsor ID
- P.T.REC/012/005595
- Conditions
- Lower Extremity Burns
- Keywords
- burn, flexibility, EMG, muscular activity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 22 Jan 2025 (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.
Tight hamstring muscles limit the anterior tilt of the pelvis in spinal flexion resulting in aggravated muscle and ligamentous tension in the lumbar region which leads to significantly higher compressive loads on the lumbar spine. Other postural changes associated with tightness of the hamstrings can influence the sacroiliac joint stability in an indirect way. Hence, flexibility of hamstring muscles is crucial for overall well-being and optimal physical fitness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration group | Experimental | Device: The whole body vibration |
| Control group | Other | Other: The traditional physical therapy program |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with a deep second-degree thermal burn of the lower extremity, 35%-40% total body surface area (TBSA) of burn as measured with the rule of nine, after six weeks from the injury or complete wound healing.
- Patients with 20 to 50 years old.
- Absence of any neurological disorder i.e.: stroke, ataxia, or parkinsonism.
Key exclusion criteria (7 listed)
- Patients with open wounds.
- Patients with recent fractures.
- Patients with severe obesity BMI ≥40.
- Patients with cardiorespiratory disorders.
- Patients with bone disease, joint replacement, and traumatic spine history since last year.
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 |
|---|---|---|
| The whole body vibrationPatients in the study group will receive the traditional physical therapy program first (passive and active ROM exercises, stretching and strengthening exercises) for 60 minutes, 3 days/ week for 12 weeks.This will be 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 from 4 to 7 mm, with an increase of 1mm every two weeks. The WBV program will be three sessions a week for 12 weeks. WBV duration started with 10 min at the 1st week up to 35 min at the 12th week, with a regular increase of five minutes every two successive weeks. | Device | Whole body vibration group |
| The traditional physical therapy programThe traditional physical therapy program will be three days a week for 12 weeks. The program will include 60 minutes of a supervised and individualized exercise program including passive and active exercises of the hip, knee, and ankle joints, stretching exercises for the Calf and hamstring muscles followed by strengthening exercises of the hip, knee, ankle, and foot muscles. To improve the strength, free weights will be used for all exercises. During the first week, 50 to 60% of the repetitions maximum test will be set as the starting weight. Then, from the second week to the sixth, the weight will be increased to 70%-75% of three repetitions maximum (3 sets, 4-10 repetitions). The training amplitude then will be raised to 80%-85% of the three-repetition maximum (3 sets, 8-12 repetitions) that will be continued through weeks 7 to 12, holding 5 seconds at the end of the range. | Other | Control group |
Primary outcome
Active Knee Extension Test:
Time frame: 12 weeks
Active knee extension test: The knee extension angle was measured using a standard goniometer. The goniometer was placed at the lateral epicondyle of the femur, with one arm aligned with the femur and the other with the tibia.
4 secondary outcomes
Straight Leg Raising Test
Time frame: 12 weeks
Electromyography for Quadriceps Muscle
Time frame: 12 weeks
Electromyography for Hamstring Muscles
Time frame: 12 weeks
The SF-36 questionnaire
Time frame: 6 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 1 Dec 2025.
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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 The whole body vibration and The traditional physical therapy program in people with Lower Extremity 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 3 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 1 Dec 2025. 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?
Active Knee Extension Test: (time frame: 12 weeks). 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 1 Dec 2025.