Lower Limb BurnNCT06801301
Comparing Effects of Whole Body Vibration and Resisted Training on Quadriceps Strength After Lower Limb Burns
A study testing whole body vibration and Resistance Exercise in people with Lower Limb Burn and Muscle Weakness Condition, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluate the therapeutic effect of Whole body vibration and Resistance training on strength of quadriceps post lower limb burn Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Lower Limb Burn, Muscle Weakness Condition
- What is being tested?
- whole body vibration and Resistance Exercise
- 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
- 1 May 2023to 1 Aug 2024
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject selection will be according to the following criteria:
- Age range between 25-40 years.
- Male and female patients will participate in the study.
- All patients have burn of 30% to 40%.
- All patients have burn at lower limb
- All patients have second degree burn
- All patients have no chronic diseases.
- All patients enrolled to the study will have their informed consent
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Prosthesis;
- Any neurological, musculoskeletal,or other chronic disease
- Participation in an outside resistance training programs
- Recent fracture or bone injury
- Any medication that could affect strength adaptations and adversely affect the results of the study
Show all 16Show fewer
- Previous brain injury
- Any disease affecting balance, vestibular or visual disorders
- History of epilepsy.
- Cardiac diseases.
- Burn of sole of foot.
- Exposed foot tendons.
- Severe osteopathy.
- Marked anemia (Ht<25%).
- Serious peripheral vessel disease
- Acute medical problem at study onset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whole Body Vibration Versus Resisted Training on Strength of Quadriceps Post Lower Limb Burn.
Evaluate the therapeutic effect of Whole body vibration and Resistance training on strength of quadriceps post lower limb burn
Read the detailed description
Study Design:
This randomized controlled trial will include 60 patients suffering from partial thickness burns. The patients will be randomly divided into two equal groups, with each group consisting of 30 patients.
Study Explanation:
A verbal explanation about the importance of the study, its procedures, main aims, and conceptual approach will be provided to every patient.
Study Procedures:
The procedures of this study will be divided into two main categories: evaluation procedures and treatment procedures.
Evaluation Procedures:
Evaluation will be conducted using isokinetic dynamometry for all patients both before and after the study.
Treatment Procedures:
First Group: Patients in the first group will receive whole body vibration therapy.
Second Group: Patients in the second group will undergo resisted exercises.
- Conditions
- Lower Limb Burn, Muscle Weakness Condition
- Being tested
- whole body vibration, Resistance Exercise
- Keywords
- Burn, Whole Body Vibration, Resisted Exercise, Isokinetic
- 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 vibrationDevice
Standing in different static positions or exercising on a vibrating platform.The mechanical stimuli of vibration transmitted to the body and stimulate muscle spindles which activate the alpha motor neurons and initiates muscle contractions comparable to the ''tonic vibration reflex. The effect of WBV on the neuromuscular properties of skeletal muscles and spinal mechanisms is demonstrated by a decreased electromechanical delay.
Resistance ExerciseOther
Resistance training as a mode of exercise to promote several health benefits, including improvements in the muscle mass and strength of healthy adults.Resistance training, where muscles are required to contract against an opposing load, has been shown to be a beneficial form of rehabilitation in clinical populations prone to muscle wasting, providing stimuli to increase protein synthesis and muscle mass.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | whole body vibration group Receives: Device: whole body vibration |
| group B | Active comparator | resistance exercises Receives: Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in quadriceps muscle strength, assessed by an isokinetic dynamometer, which measures the peak torque of the quadriceps.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 May 2023
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb BurnStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah mohamed shafiek abuelfadl, Cairo University
- Investigators
- Eman Mohamed Othman, doctoral degree, Study director, Cairo UniversityKhadra Mohamed Ali, Doctoral degree, Study chair, Cairo UniversityAshraf El Sebaie Mohamed, doctoral, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801301
- Sponsor's protocol ID
- P.T.REC/012/002762
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration Versus Resisted Training on Strength of Quadriceps Post Lower Limb Burn.
- ClinicalTrials.gov ID
- NCT06801301
- Acronym / sponsor ID
- P.T.REC/012/002762
- Conditions
- Lower Limb Burn, Muscle Weakness Condition
- Keywords
- Burn, Whole Body Vibration, Resisted Exercise, Isokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 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.
Evaluate the therapeutic effect of Whole body vibration and Resistance training on strength of quadriceps post lower limb burn
Detailed description
Study Design:
This randomized controlled trial will include 60 patients suffering from partial thickness burns. The patients will be randomly divided into two equal groups, with each group consisting of 30 patients.
Study Explanation:
A verbal explanation about the importance of the study, its procedures, main aims, and conceptual approach will be provided to every patient.
Study Procedures:
The procedures of this study will be divided into two main categories: evaluation procedures and treatment procedures.
Evaluation Procedures:
Evaluation will be conducted using isokinetic dynamometry for all patients both before and after the study.
Treatment Procedures:
First Group: Patients in the first group will receive whole body vibration therapy.
Second Group: Patients in the second group will undergo resisted exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: whole body vibrationwhole body vibration group |
| group B | Active comparator | Other: Resistance Exerciseresistance exercises |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age range between 25-40 years.
- Male and female patients will participate in the study.
- All patients have burn of 30% to 40%.
- All patients have burn at lower limb
- All patients have second degree burn
Key exclusion criteria (16 listed)
- Prosthesis;
- Any neurological, musculoskeletal,or other chronic disease
- Participation in an outside resistance training programs
- Recent fracture or bone injury
- Any medication that could affect strength adaptations and adversely affect the results of the study
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 vibrationStanding in different static positions or exercising on a vibrating platform.The mechanical stimuli of vibration transmitted to the body and stimulate muscle spindles which activate the alpha motor neurons and initiates muscle contractions comparable to the ''tonic vibration reflex. The effect of WBV on the neuromuscular properties of skeletal muscles and spinal mechanisms is demonstrated by a decreased electromechanical delay. | Device | group A |
| Resistance ExerciseResistance training as a mode of exercise to promote several health benefits, including improvements in the muscle mass and strength of healthy adults.Resistance training, where muscles are required to contract against an opposing load, has been shown to be a beneficial form of rehabilitation in clinical populations prone to muscle wasting, providing stimuli to increase protein synthesis and muscle mass. | Other | group B |
Primary outcome
Increase in quadriceps muscle strength, assessed by an isokinetic dynamometer, which measures the peak torque of the quadriceps.
Time frame: 8 weeks
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 30 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for Lower Limb Burn
Not yet recruiting
Frenkel Exercises on Balance and Quality of Life Post Burns
Burns, Lower Limb Burn Injury
Not yet recruiting
EFFECT OF PLYOMETRIC EXERCISES ON LOWER LIMB FUNCTIONS FOLLOWING PEDIATRIC BURN
Lower Limb Function, Lower Limb Burn
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.
Eman Mohamed Othman, doctoral degree study director
Cairo University
Khadra Mohamed Ali, Doctoral degree study chair
Cairo University
Ashraf El Sebaie Mohamed, doctoral study director
Cairo University
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 and Resistance Exercise in people with Lower Limb Burn and Muscle Weakness Condition, 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 8 inclusion and 16 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 30 Jan 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?
Increase in quadriceps muscle strength, assessed by an isokinetic dynamometer, which measures the peak torque of the quadriceps. (time frame: 8 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 30 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.