- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06801301
Comparing Effects of Whole Body Vibration and Resisted Training on Quadriceps Strength After Lower Limb Burns
Whole Body Vibration Versus Resisted Training on Strength of Quadriceps Post Lower Limb Burn.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 12613
- Faculty of Physical Therapy Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A
whole body vibration group
|
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.
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Active Comparator: group B
resistance exercises
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Increase in quadriceps muscle strength, assessed by an isokinetic dynamometer, which measures the peak torque of the quadriceps.
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eman Mohamed Othman, doctoral degree, Cairo university
- Study Chair: Khadra Mohamed Ali, Doctoral degree, Cairo university
- Study Director: Ashraf El Sebaie Mohamed, doctoral, Cairo university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/002762
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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