<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/NCT04486703</url>
  </required_header>
  <id_info>
    <org_study_id>6m8</org_study_id>
    <nct_id>NCT04486703</nct_id>
  </id_info>
  <brief_title>Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn</brief_title>
  <official_title>Effect of Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn: a Twelve-week Randomized Controlled Study</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>
      The purpose of the current study was to evaluate the effect of physical therapy&#xD;
      rehabilitation program combined with music therapy on pediatric with lower limb burn.&#xD;
      Methods. A twelve-week randomized controlled study including thirty lower limb pediatric&#xD;
      burned patients who randomly divided into two groups, Group(A) received physical therapy&#xD;
      rehabilitation program combined with music therapy in addition to routine medical care while&#xD;
      Group (B) received physical therapy rehabilitation program without music therapy. Pain was&#xD;
      assessed by visual analogue scale (VAS) and range of motion (ROM) was assessed by goniometer,&#xD;
      and gait assessed by GAIT Rite. Assessment was carried before and after treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2018</start_date>
  <completion_date type="Actual">June 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2019</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>pain in the lower limb</measure>
    <time_frame>12 weeks</time_frame>
    <description>Visual analogue scale for pain assessment ,zero indicates no pain ten indicates maximum pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lower Limb Burn</condition>
  <arm_group>
    <arm_group_label>Exercise with music group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>physical therapy program combined with music therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>physical therapy program without music</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise with music</intervention_name>
    <description>physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.</description>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_label>Exercise with music group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lower limb 2nd degree burn since 6 weeks&#xD;
&#xD;
          -  Burn affect skin around ankle and knee joint,&#xD;
&#xD;
          -  Both sex, age ranged between 10 to 15 years old&#xD;
&#xD;
          -  Patients have sufficient cognition and education enough to understand the requirements&#xD;
             of this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients with age more than 15 years or less than 10 years&#xD;
&#xD;
          -  Patients with hearing problems&#xD;
&#xD;
          -  Acute viral diseases, acute tuberculosis, mental disorders&#xD;
&#xD;
          -  Those with pace makers, diabetics, cardiac, renal patients&#xD;
&#xD;
          -  Patients with genetic disease&#xD;
&#xD;
          -  3rd degree burn and 1st degree bum&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marwa Eid</name>
      <address>
        <city>Cairo</city>
        <zip>2011</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Marwa Eid</investigator_full_name>
    <investigator_title>assistant professor of physical therapy for surgery</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>Undecided</sharing_ipd>
  </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/NCT04486703
org study id: 6m8
nct id: NCT04486703
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the current study was to evaluate the effect of physical therapy
      rehabilitation program combined with music therapy on pediatric with lower limb burn.
      Methods. A twelve-week randomized controlled study including thirty lower limb pediatric
      burned patients who randomly divided into two groups, Group(A) received physical therapy
      rehabilitation program combined with music therapy in addition to routine medical care while
      Group (B) received physical therapy rehabilitation program without music therapy. Pain was
      assessed by visual analogue scale (VAS) and range of motion (ROM) was assessed by goniometer,
      and gait assessed by GAIT Rite. Assessment was carried before and after treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: pain in the lower limb
time frame: 12 weeks
description: Visual analogue scale for pain assessment ,zero indicates no pain ten indicates maximum pain
arm group label: Exercise with music group
arm group type: Experimental
description: physical therapy program combined with music therapy
arm group label: Exercise group
arm group type: Experimental
description: physical therapy program without music
intervention type: Other
intervention name: Exercise with music
description: physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.
arm group label: Exercise group
arm group label: Exercise with music group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 15 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Marwa Eid
investigator title: assistant professor of physical therapy for surgery
mesh term: Burns
sharing ipd: Undecided