Impact of Whole-body Vibration Training on Flexibility, Muscular Activity and Quality of Life After Lower Extremity Thermal Burn Injury

November 27, 2025 updated by: Rokaia Ali Zainelabedeen Mohamed Toson, Cairo University
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 Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Giza Governorate
      • Cairo, Giza Governorate, Egypt
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. 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.
  2. Patients with 20 to 50 years old.
  3. Absence of any neurological disorder i.e.: stroke, ataxia, or parkinsonism.

Exclusion criteria:

  1. Patients with open wounds.
  2. Patients with recent fractures.
  3. Patients with severe obesity BMI ≥40.
  4. Patients with cardiorespiratory disorders.
  5. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Experimental: Whole body vibration group
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.

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.
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
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.
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.
12 weeks
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)

  • 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

6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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