- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06787716
Impact of Whole-body Vibration Training on Flexibility, Muscular Activity and Quality of Life After Lower Extremity Thermal Burn Injury
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Giza Governorate
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Cairo, Giza Governorate, Egypt
- 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:
- 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.
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Control group
|
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.
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Experimental: Whole body vibration group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Straight Leg Raising Test
Time Frame: 12 weeks
|
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.
|
12 weeks
|
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Electromyography for Quadriceps Muscle
Time Frame: 12 weeks
|
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.
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12 weeks
|
|
Electromyography for Hamstring Muscles
Time Frame: 12 weeks
|
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.
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12 weeks
|
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The SF-36 questionnaire
Time Frame: 6 months
|
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)
Interpretation: 0 = Worst possible health status for that domain 100 = Best possible health status for that domain |
6 months
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005595
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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