<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/NCT04491812</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/001922</org_study_id>
    <nct_id>NCT04491812</nct_id>
  </id_info>
  <brief_title>Triceps Taping on Elbow Flexion Tightness in Extended Erb's Palsy</brief_title>
  <official_title>Role of Triceps Kinesiology Taping on Elbow Flexion Tightness in Extended Erb's Palsy Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MTI University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MTI 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>
      To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness&#xD;
      in infants with extended Erb's palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE:&#xD;
&#xD;
      To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness&#xD;
      in infants with extended Erb's palsy.&#xD;
&#xD;
      BACKGROUND:&#xD;
&#xD;
      BACKGROUND Neglecting or even delay in Brachial plexus birth palsy management, may result in&#xD;
      substantial and chronic impairment. Physiotherapy, microsurgical nerve reconstruction,&#xD;
      secondary joint corrections, and muscle transpositions are employed to help the child&#xD;
      maximize function in the affected upper extremity. Kinesiology taping can have an effect on&#xD;
      muscle performance and support joint by improving proprioception, normalizing muscle tone,&#xD;
      correct the inappropriate positions and stimulate skin receptors. The possible effect of&#xD;
      kinesiotaping on muscle strength has been investigated by numerous researchers that have&#xD;
      theorized that kinesiotaping facilitates an immediate increase in muscle strength by&#xD;
      generating a concentric pull on the fascia.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      There will be no role of Kinesiology tape on the prevention of elbow flexion tightness in&#xD;
      infants with extended Erb's palsy.&#xD;
&#xD;
      RESEARCH QUESTION:&#xD;
&#xD;
      Is there a role of using Kinesiology tape in preventing elbow flexion tightness in infants&#xD;
      with extended Erb's palsy?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 10, 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>
    <intervention_model_description>Group A: physical therapy program Group B: physical therapy program inaddition to kinesiotaping</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>single blind masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Elbow extension ROM</measure>
    <time_frame>3 months</time_frame>
    <description>The range of motion of the extension of the elbow will be measured by smartphone goniometer &quot;G-Pro&quot; and recorded in &quot;degrees&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>muscle strength</measure>
    <time_frame>3 months</time_frame>
    <description>elbow flexors and extensors muscle strength will be measured using the &quot;Toronto Active Movement Scale&quot; and recorded by number scale from 0-7; 0 meaning no contraction while 7 mean normal power</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Deformity Flexion</condition>
  <arm_group>
    <arm_group_label>Kinesiotaping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>kinesiotaping of the triceps muscle applied to the study group alongside the physical therapy program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physical therapy program</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>the control group recieved only the physical therapy program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesio Tape</intervention_name>
    <description>Elastic Kinesiology Tape</description>
    <arm_group_label>Kinesiotaping</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical therapy program</intervention_name>
    <description>designed physical therapy program</description>
    <arm_group_label>physical therapy program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3-6 months of age&#xD;
&#xD;
          -  had unilateral extended BPBP involving cervical 5, 6, and 7 roots lesion&#xD;
&#xD;
          -  based on an EMG referral by a physiatrist&#xD;
&#xD;
          -  had positive grasp reflex on both sides&#xD;
&#xD;
          -  had asymmetrical Moro reflex on the affected side.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - surgical interferences arm fracture or dislocations hypersensitivity to latex and&#xD;
        adhesive tapes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Radwa S Ahmed, MSc</last_name>
    <phone>+201004008503</phone>
    <email>radwa.said@pt.mti.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty pf physical therapy, Cairo University</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Radwa S Ahmed, MSc</last_name>
      <phone>+201004008503</phone>
      <email>radwa.said@pt.mti.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MTI University</investigator_affiliation>
    <investigator_full_name>Radwa Said</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brachial Plexus Neuropathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT04491812/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04491812
org study id: P.T.REC/012/001922
nct id: NCT04491812
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness
      in infants with extended Erb's palsy.
PURPOSE:

      To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness
      in infants with extended Erb's palsy.

      BACKGROUND:

      BACKGROUND Neglecting or even delay in Brachial plexus birth palsy management, may result in
      substantial and chronic impairment. Physiotherapy, microsurgical nerve reconstruction,
      secondary joint corrections, and muscle transpositions are employed to help the child
      maximize function in the affected upper extremity. Kinesiology taping can have an effect on
      muscle performance and support joint by improving proprioception, normalizing muscle tone,
      correct the inappropriate positions and stimulate skin receptors. The possible effect of
      kinesiotaping on muscle strength has been investigated by numerous researchers that have
      theorized that kinesiotaping facilitates an immediate increase in muscle strength by
      generating a concentric pull on the fascia.

      HYPOTHESES:

      There will be no role of Kinesiology tape on the prevention of elbow flexion tightness in
      infants with extended Erb's palsy.

      RESEARCH QUESTION:

      Is there a role of using Kinesiology tape in preventing elbow flexion tightness in infants
      with extended Erb's palsy?
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group A: physical therapy program Group B: physical therapy program inaddition to kinesiotaping
primary purpose: Prevention
masking: Single (Participant)
masking description: single blind masking
measure: Elbow extension ROM
time frame: 3 months
description: The range of motion of the extension of the elbow will be measured by smartphone goniometer "G-Pro" and recorded in "degrees"
measure: muscle strength
time frame: 3 months
description: elbow flexors and extensors muscle strength will be measured using the "Toronto Active Movement Scale" and recorded by number scale from 0-7; 0 meaning no contraction while 7 mean normal power
arm group label: Kinesiotaping
arm group type: Experimental
description: kinesiotaping of the triceps muscle applied to the study group alongside the physical therapy program
arm group label: physical therapy program
arm group type: Placebo Comparator
description: the control group recieved only the physical therapy program
intervention type: Other
intervention name: Kinesio Tape
description: Elastic Kinesiology Tape
arm group label: Kinesiotaping
intervention type: Other
intervention name: Physical therapy program
description: designed physical therapy program
arm group label: physical therapy program
criteria: 
gender: All
minimum age: 3 Months
maximum age: 6 Months
healthy volunteers: No
last name: Radwa S Ahmed, MSc
phone: +201004008503
email: radwa.said@pt.mti.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: MTI University
investigator full name: Radwa Said
investigator title: Principal Investigator
mesh term: Brachial Plexus Neuropathies
sharing ipd: No
provided document: 