xml: <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/NCT06036082</url>
    </required_header>
    <id_info>
      <org_study_id>REC/2111/MTI.PT/2204062</org_study_id>
      <nct_id>NCT06036082</nct_id>
    </id_info>
    <brief_title>Improvement by Isokinetic and Treadmill Training on Muscle Strength and Gait in Burned Childre</brief_title>
    <official_title>Isokinetic Training Versus Treadmill Training on Muscle Strength and Gait in Children With Lower Limb Burns</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>South Valley University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>South Valley 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>
        Burn wounds are one of the most complexes and dramatic of all injuries, it produces a direct&#xD;
        local tissue destruction and damage. In addition, burn wounds may continue to destroy tissue&#xD;
        and muscles, exercise therapy stimulates the early expression of angiogenesis-related growth&#xD;
        factors so it results in new vessel in-growth that improves blood supply, increases cell&#xD;
        proliferation, accelerates tissue regeneration and healing and regain muscle strength&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To evaluate the efficacy of isokinetic training against treadmill training in improving&#xD;
        muscle strength and gait in children having lower limb burns. Methods: Sixty children from&#xD;
        both genders (boys and girls) who were complaining from 2nd degree lower limb burns with ≥30&#xD;
        percent of their total body surface area (TBSA) participated in this study, their ages ranged&#xD;
        from 8 to 16 years and they were randomized into three groups of same number (A, B and C).&#xD;
        Groups (A) received conventional physical therapy program, group (B) received the same&#xD;
        conventional physical therapy program of group (A) with trained to use the isokinetic device&#xD;
        while group (C) received the same conventional physical therapy program of group (A and B)&#xD;
        and used treadmill training. The children participated in this study were assessed by&#xD;
        Hand-held dynamometer (HHD) and Balance Master System (BMS). They were evaluated before and&#xD;
        after the treatment program three sessions per week for 12 consecutive weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</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>
      <intervention_model_description>randomized control study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Balance Master System</measure>
      <time_frame>before intervention and after 12 weeks of intervention</time_frame>
      <description>It is the most significant test to measure balance and has valid values of functional balance performance</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hand-held dynamometer</measure>
      <time_frame>before intervention and after 12 weeks of intervention</time_frame>
      <description>It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Burned</condition>
    <arm_group>
      <arm_group_label>Conventional physical therapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It consisted of 20 children received conventional physical therapy program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>isokinetic training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It consisted of 20 children received conventional physical therapy program and isokinetic training</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treadmill training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It consisted of 20 children received conventional physical therapy program and treadmill training</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional physical therapy</intervention_name>
      <description>Standing with feet together .&#xD;
  Step standing .&#xD;
  High step standing and trying to keep balanced.&#xD;
  Single leg stance &quot;unilateral standing&quot; with assistance.&#xD;
  Standing on a declined surface by using wedge.&#xD;
  Standing with manual locking of the knees.&#xD;
  Changing position.&#xD;
  Gait training.&#xD;
  Static and dynamic muscle contraction.</description>
      <arm_group_label>Conventional physical therapy group</arm_group_label>
      <arm_group_label>Treadmill training group</arm_group_label>
      <arm_group_label>isokinetic training group</arm_group_label>
      <other_name>physical therapy program</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children aged between 8 to 16 year&#xD;
  &#xD;
            -  Complaining from 2nd degree lower limb burns (≥30 % of their TBSA).&#xD;
  &#xD;
            -  Capable of standing and walking independently.&#xD;
  &#xD;
            -  Clinically and medically stable.&#xD;
  &#xD;
            -  Sufficient cognition demonstrating understanding the requirements of the study.&#xD;
  &#xD;
            -  No history of lower extremity surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Visual and/or auditory defects.&#xD;
  &#xD;
            -  Significant shortening and/or deformity of lower extremities.&#xD;
  &#xD;
            -  Other neurological problems that affect balance or mentality (e.g. epilepsy).&#xD;
  &#xD;
            -  Advanced radiographic changes include (bone destruction, bony ankylosis, knee joint&#xD;
               sublaxation and epiphysial fracture).&#xD;
  &#xD;
            -  Congenital or acquired skeletal deformities in the lower limbs.&#xD;
  &#xD;
            -  Cardiopulmonary dysfunction.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ragaee Saeed Mahmoud</name>
        <address>
          <city>Faisal</city>
          <state>Giza</state>
          <zip>00202</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ragaee Mahmoud</last_name>
        <phone>00201223611112</phone>
        <email>ragaeesaeedpt10@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Reham Mahmoud</last_name>
        <phone>00201015447798</phone>
        <email>rsm_211pt@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>South Valley University</investigator_affiliation>
      <investigator_full_name>Ragaee Saeed Mahmoud</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Burn; Children; Isokinetic Training; Treadmill Training</keyword>
    <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>assessed before and after treatment</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>12 weeks</ipd_time_frame>
      <ipd_access_criteria>accepted</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036082
  org study id: REC/2111/MTI.PT/2204062
  nct id: NCT06036082
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Burn wounds are one of the most complexes and dramatic of all injuries, it produces a direct
        local tissue destruction and damage. In addition, burn wounds may continue to destroy tissue
        and muscles, exercise therapy stimulates the early expression of angiogenesis-related growth
        factors so it results in new vessel in-growth that improves blood supply, increases cell
        proliferation, accelerates tissue regeneration and healing and regain muscle strength
  To evaluate the efficacy of isokinetic training against treadmill training in improving
        muscle strength and gait in children having lower limb burns. Methods: Sixty children from
        both genders (boys and girls) who were complaining from 2nd degree lower limb burns with ≥30
        percent of their total body surface area (TBSA) participated in this study, their ages ranged
        from 8 to 16 years and they were randomized into three groups of same number (A, B and C).
        Groups (A) received conventional physical therapy program, group (B) received the same
        conventional physical therapy program of group (A) with trained to use the isokinetic device
        while group (C) received the same conventional physical therapy program of group (A and B)
        and used treadmill training. The children participated in this study were assessed by
        Hand-held dynamometer (HHD) and Balance Master System (BMS). They were evaluated before and
        after the treatment program three sessions per week for 12 consecutive weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized control study
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Balance Master System
  time frame: before intervention and after 12 weeks of intervention
  description: It is the most significant test to measure balance and has valid values of functional balance performance
  measure: Hand-held dynamometer
  time frame: before intervention and after 12 weeks of intervention
  description: It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method
  arm group label: Conventional physical therapy group
  arm group type: Experimental
  description: It consisted of 20 children received conventional physical therapy program
  arm group label: isokinetic training group
  arm group type: Experimental
  description: It consisted of 20 children received conventional physical therapy program and isokinetic training
  arm group label: Treadmill training group
  arm group type: Experimental
  description: It consisted of 20 children received conventional physical therapy program and treadmill training
  intervention type: Other
  intervention name: Conventional physical therapy
  description: Standing with feet together .
  Step standing .
  High step standing and trying to keep balanced.
  Single leg stance "unilateral standing" with assistance.
  Standing on a declined surface by using wedge.
  Standing with manual locking of the knees.
  Changing position.
  Gait training.
  Static and dynamic muscle contraction.
  arm group label: Conventional physical therapy group
  arm group label: Treadmill training group
  arm group label: isokinetic training group
  other name: physical therapy program
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 16 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: South Valley University
  investigator full name: Ragaee Saeed Mahmoud
  investigator title: Lecturer
  mesh term: Burns
  sharing ipd: Yes
  ipd description: assessed before and after treatment
  ipd info type: Study Protocol
  ipd time frame: 12 weeks
  ipd access criteria: accepted