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/NCT05967793</url>
    </required_header>
    <id_info>
      <org_study_id>Benha University</org_study_id>
      <nct_id>NCT05967793</nct_id>
    </id_info>
    <brief_title>Effect of Kinesiology Taping on Head and Trunk Control in Children With Duchenne Muscular Dystrophy</brief_title>
    <official_title>Effect of Kinesiology Taping on Head and Trunk Control in Children With Duchenne Muscular Dystrophy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Egyptian Chinese University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Benha University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Egyptian Chinese 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>
        Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening&#xD;
        and breakdown of skeletal muscles over time. The disorders differ in which muscles are&#xD;
        primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin.&#xD;
        Many people will eventually become unable to walk. Some types are also associated with&#xD;
        problems in other organs. The muscular dystrophy group contains thirty different genetic&#xD;
        disorders that are usually classified into nine main categories or types.&#xD;
  &#xD;
        The signs and symptoms consistent with muscular dystrophy are: progressive muscular wasting,&#xD;
        poor balance, scoliosis (curvature of the spine and the back), progressive inability to walk,&#xD;
        waddling gait, Calf deformation, Limited range of movement, respiratory difficulty,&#xD;
        cardiomyopathy and muscle spasms This study aimed to assess the efficacy of Kinesiology&#xD;
        Taping on head and trunk control in patients with Duchenne muscular dystrophy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Duchenne Muscular Dystrophy (DMD) is the most common muscular dystrophy type in childhood.&#xD;
        Trunk control is responsible for adaptation during weight transfers, provides and maintains&#xD;
        the upright position of the body, organizes postural and correction reactions; and stabilizes&#xD;
        the body to perform proximal and distal limb movements, trunk rotations, and making contact&#xD;
        between the shoulder and pelvis. In neuromuscular diseases, the trunk is usually ignored both&#xD;
        for assessment and treatment as muscle weakness of limbs attracts more attention. Therapists&#xD;
        usually focus on activities of lower limb and overhead including standing, walking, climbing,&#xD;
        and raising arms to maintain independent mobility in rehabilitation sessions. However, the&#xD;
        trunk also gradually gets weaker as the child gets older and this may be associated with&#xD;
        movement dysfunction of upper and lower limbs. The Kinesio Taping method is used in the&#xD;
        rehabilitation of musculoskeletal disorders, providing either an increase or a decrease in&#xD;
        the neural excitation of the muscle, depending on the therapeutic purpose determined after&#xD;
        the clinical assessment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>H-reflex latency and amplitude for trunk extensor</measure>
      <time_frame>through study completion, an average of 3 months</time_frame>
      <description>H- reflex will be measured by an electromyogram device, four channels electrodiagnostic system with built in amplifier will be used in prone position for levator scapulae muscles and iliocostalis lumborum muscles</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Duchenne Muscular Dystrophy</condition>
    <arm_group>
      <arm_group_label>kinesio tape</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Kinesio Tape will be applied on paraspinal trunk extensors muscles for 8 weeks, changed every 3 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Routine physical therapy program</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>routine physical therapy exercise</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>kinesio tape</intervention_name>
      <description>Kinesio Tape will be applied on paraspinal trunk extensors muscles for 8 weeks, changed every 3 days.</description>
      <arm_group_label>Routine physical therapy program</arm_group_label>
      <arm_group_label>kinesio tape</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. being at the age of 8-12 years&#xD;
  &#xD;
            2. being able to cooperate with the instructions of physiotherapist to perform the&#xD;
               assessments and procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. having severe contracture at lower extremities&#xD;
  &#xD;
            2. having another neurological and/or musculoskeletal disease diagnosis in addition to&#xD;
               DMD. c) having a history of any lower extremity injury or orthopedic/neurologic&#xD;
               surgery within the past 6 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Noha Elserty, ASS. prof.</last_name>
      <phone>01006709648</phone>
      <email>noha.serty@fpt.bu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Noha Elserty</name>
        <address>
          <city>Cairo</city>
          <zip>11835</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Noha Elserty</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Benha University</investigator_affiliation>
      <investigator_full_name>Noha Elserty</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscular Dystrophies</mesh_term>
      <mesh_term>Muscular Dystrophy, Duchenne</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05967793
  org study id: Benha University
  nct id: NCT05967793
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening
        and breakdown of skeletal muscles over time. The disorders differ in which muscles are
        primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin.
        Many people will eventually become unable to walk. Some types are also associated with
        problems in other organs. The muscular dystrophy group contains thirty different genetic
        disorders that are usually classified into nine main categories or types.
  
        The signs and symptoms consistent with muscular dystrophy are: progressive muscular wasting,
        poor balance, scoliosis (curvature of the spine and the back), progressive inability to walk,
        waddling gait, Calf deformation, Limited range of movement, respiratory difficulty,
        cardiomyopathy and muscle spasms This study aimed to assess the efficacy of Kinesiology
        Taping on head and trunk control in patients with Duchenne muscular dystrophy
  Duchenne Muscular Dystrophy (DMD) is the most common muscular dystrophy type in childhood.
        Trunk control is responsible for adaptation during weight transfers, provides and maintains
        the upright position of the body, organizes postural and correction reactions; and stabilizes
        the body to perform proximal and distal limb movements, trunk rotations, and making contact
        between the shoulder and pelvis. In neuromuscular diseases, the trunk is usually ignored both
        for assessment and treatment as muscle weakness of limbs attracts more attention. Therapists
        usually focus on activities of lower limb and overhead including standing, walking, climbing,
        and raising arms to maintain independent mobility in rehabilitation sessions. However, the
        trunk also gradually gets weaker as the child gets older and this may be associated with
        movement dysfunction of upper and lower limbs. The Kinesio Taping method is used in the
        rehabilitation of musculoskeletal disorders, providing either an increase or a decrease in
        the neural excitation of the muscle, depending on the therapeutic purpose determined after
        the clinical assessment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: H-reflex latency and amplitude for trunk extensor
  time frame: through study completion, an average of 3 months
  description: H- reflex will be measured by an electromyogram device, four channels electrodiagnostic system with built in amplifier will be used in prone position for levator scapulae muscles and iliocostalis lumborum muscles
  arm group label: kinesio tape
  arm group type: Experimental
  description: Kinesio Tape will be applied on paraspinal trunk extensors muscles for 8 weeks, changed every 3 days.
  arm group label: Routine physical therapy program
  arm group type: Active Comparator
  description: routine physical therapy exercise
  intervention type: Other
  intervention name: kinesio tape
  description: Kinesio Tape will be applied on paraspinal trunk extensors muscles for 8 weeks, changed every 3 days.
  arm group label: Routine physical therapy program
  arm group label: kinesio tape
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Noha Elserty, ASS. prof.
  phone: 01006709648
  email: noha.serty@fpt.bu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Benha University
  investigator full name: Noha Elserty
  investigator title: Assistant professor
  mesh term: Muscular Dystrophies
  mesh term: Muscular Dystrophy, Duchenne
  sharing ipd: Undecided