<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04500314</url>
  </required_header>
  <id_info>
    <org_study_id>182020</org_study_id>
    <nct_id>NCT04500314</nct_id>
  </id_info>
  <brief_title>Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.</brief_title>
  <official_title>Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries. Prospective Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to investigate the effect of whole-body vibration device on&#xD;
      Balance control, postural Stability and mobility after thermal burn injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      40 patients with deep second-degree burn involving the lower limbs and trunk (TBSA: 35-40%),&#xD;
      will be randomly assigned either into the experimental group, received whole body vibration&#xD;
      (WBV) plus the routine physical therapy program or the control group, received the same&#xD;
      routine physical therapy program. All treatment interventions will be applied at a frequency&#xD;
      of three sessions per week for 8 weeks. Anteroposterior stability (APS), Medial lateral&#xD;
      stability (MLS), Time up and go test (TUG) test, and Berg balance scale will be the outcome&#xD;
      measures of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Actual">December 28, 2020</completion_date>
  <primary_completion_date type="Actual">December 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postural stability</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>The antero-posterior stability index (APSI) was measured for all cases before and after eight weeks of treatment. This index will be standard deviations assessing fluctuations around the zero point (horizontal) rather than around a group mean. The APSI assessed the fluctuations from the horizontal along the AP on the BSS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time up and go test</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>The TUG test used to measure mobility. Participants were asked to raise up from sitting in a chair to a standing position and to walk a distance of 3 m, turn around, walk back to the chair, and sit down again with their backs flush to the back of the chair and with arms resting on the arm rests. The time for participants to complete the task was measured in seconds with a stopwatch. The best, or lowest time from 3 trials, was used in the analysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Thermal Burn</condition>
  <arm_group>
    <arm_group_label>Whole body vibration plus routine physical therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine physical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>whole body vibration device</intervention_name>
    <description>20 patients will receive vibration training on vibration platform (Power Plate International, Irvine, California, USA) at a frequency of 25-30 Hz and amplitude of 3-5mm, plus traditional physical therapy program 3 sessions per week for total period of 8 weeks. The total duration of the WBV training stimulus will 10 min in first week and progress gradually to 25 min in the 8th week with regular increase by 5 minutes after each 2 successive weeks</description>
    <arm_group_label>Whole body vibration plus routine physical therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>routine physical therapy treatment</intervention_name>
    <description>The program consists of 60 minutes supervised and individualized stretching exercise to all involved muscles followed by strengthening for affected muscles, mobilizing exercise for the joints involved to increase the joint range of motion, in addition to scar management techniques including pressure garments, inserts, and physical agent modalities , to avoid scar or contracture formation</description>
    <arm_group_label>Routine physical therapy</arm_group_label>
    <arm_group_label>Whole body vibration plus routine physical therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ranged between 20 and 45 years,&#xD;
&#xD;
          -  Deep 2nd degree of thermal burn of lower limb and trunk with (35-40%) surface area of&#xD;
             burn as measured by &quot;rule of nine&quot; method, with complete wound healing or after 6&#xD;
             weeks from the injury.&#xD;
&#xD;
          -  Body mass index of between 17 and 35, with no history of neurological disorders or&#xD;
             injuries to the lower extremities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with open burn wound,&#xD;
&#xD;
          -  Patients diagnosed with acute rheumatoid arthritis,&#xD;
&#xD;
          -  Joint replacement within the past year,&#xD;
&#xD;
          -  History of traumatic spine within the past six months,&#xD;
&#xD;
          -  Prosthesis,&#xD;
&#xD;
          -  Recent fracture or bone disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University, Faculty of physical therapy.</name>
      <address>
        <city>Cairo</city>
        <state>Giza</state>
        <zip>12322</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hadaya Mosaad</investigator_full_name>
    <investigator_title>Lecturer, department of physical therapy for surgery, Faculty of Physical Therapy , Cairo university.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>after 6 month from the date of publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>After 6 month of publication.</ipd_time_frame>
    <ipd_access_criteria>Study protocol. Informed consent form</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04500314
org study id: 182020
nct id: NCT04500314
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to investigate the effect of whole-body vibration device on
      Balance control, postural Stability and mobility after thermal burn injuries.
40 patients with deep second-degree burn involving the lower limbs and trunk (TBSA: 35-40%),
      will be randomly assigned either into the experimental group, received whole body vibration
      (WBV) plus the routine physical therapy program or the control group, received the same
      routine physical therapy program. All treatment interventions will be applied at a frequency
      of three sessions per week for 8 weeks. Anteroposterior stability (APS), Medial lateral
      stability (MLS), Time up and go test (TUG) test, and Berg balance scale will be the outcome
      measures of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Postural stability
time frame: 8 weeks of treatment
description: The antero-posterior stability index (APSI) was measured for all cases before and after eight weeks of treatment. This index will be standard deviations assessing fluctuations around the zero point (horizontal) rather than around a group mean. The APSI assessed the fluctuations from the horizontal along the AP on the BSS
measure: Time up and go test
time frame: 8 weeks of treatment
description: The TUG test used to measure mobility. Participants were asked to raise up from sitting in a chair to a standing position and to walk a distance of 3 m, turn around, walk back to the chair, and sit down again with their backs flush to the back of the chair and with arms resting on the arm rests. The time for participants to complete the task was measured in seconds with a stopwatch. The best, or lowest time from 3 trials, was used in the analysis
arm group label: Whole body vibration plus routine physical therapy
arm group type: Experimental
arm group label: Routine physical therapy
arm group type: Active Comparator
intervention type: Device
intervention name: whole body vibration device
description: 20 patients will receive vibration training on vibration platform (Power Plate International, Irvine, California, USA) at a frequency of 25-30 Hz and amplitude of 3-5mm, plus traditional physical therapy program 3 sessions per week for total period of 8 weeks. The total duration of the WBV training stimulus will 10 min in first week and progress gradually to 25 min in the 8th week with regular increase by 5 minutes after each 2 successive weeks
arm group label: Whole body vibration plus routine physical therapy
intervention type: Other
intervention name: routine physical therapy treatment
description: The program consists of 60 minutes supervised and individualized stretching exercise to all involved muscles followed by strengthening for affected muscles, mobilizing exercise for the joints involved to increase the joint range of motion, in addition to scar management techniques including pressure garments, inserts, and physical agent modalities , to avoid scar or contracture formation
arm group label: Routine physical therapy
arm group label: Whole body vibration plus routine physical therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hadaya Mosaad
investigator title: Lecturer, department of physical therapy for surgery, Faculty of Physical Therapy , Cairo university.
mesh term: Burns
sharing ipd: Yes
ipd description: after 6 month from the date of publication
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: After 6 month of publication.
ipd access criteria: Study protocol. Informed consent form