<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/NCT03821740</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03821740</nct_id>
  </id_info>
  <brief_title>Kinesiotaping for Normalizing Scapular Dyskinesis</brief_title>
  <official_title>Kinesiotaping for Normalizing Scapular Dyskinesis : the Influence on Scapular Kinematics and on the Activity of Scapular Stabilizing Muscles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The 3-dimensional position and orientation of the scapula as well as muscle activation of&#xD;
      upper trapezius (UT), lower trapezius (LT) and serratus anterior (SA) of asymptomatic&#xD;
      dyskinetic sportspeole will be recorded during shoulder flexion and shoulder abduction, in&#xD;
      loaded and unloaded conditions. Participants will be assessed in standard condition and with&#xD;
      two differents kinesiotaping techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 20 dyskinetic asymptomatic people will be involved in the study. The objective will be&#xD;
      to compare two different kinesiotaping techniques in normalizing scapular kinematics.&#xD;
&#xD;
      Tridimensional-movement of the scapula and EMG activity of periscapular muscles will be&#xD;
      evaluated doing flexion (sagittal plane) and abduction (frontal plane) movements.&#xD;
&#xD;
      EMG acquisitions :&#xD;
&#xD;
      The electromyographic (EMG) signals are collected with Trigno Standard and Trigno Mini&#xD;
      wireless sensors (Delsys, Boston, MA, USA) using silver-contact bipolar bar electrodes with&#xD;
      ﬁxed 10 mm inter-electrode spacing [49]. Three of the main scapular stabilizing muscles of&#xD;
      the shoulder are investigated: upper trapezius, lower trapezius and serratus anterior.&#xD;
      Electrodes are placed on the dyskinetic side. In case of bilateral scapular dyskinesis,&#xD;
      electrodes are placed on the side where the most important dysfunction was observed. Data are&#xD;
      acquired at a sample frequency of 1000 Hz.&#xD;
&#xD;
      Tridimensionnal assessment:&#xD;
&#xD;
      Scapular kinematics is assessed using a three-dimensional motion analysis system, an&#xD;
      optoelectronic system based on active markers (Codamotion, Charnwood Dynamic, UK). For that&#xD;
      purpose, four Codamotion CX1 units are used, at a sampling of 100 Hz. Fifteen active markers&#xD;
      were placed on the skin of the subject on the same side as EMG electrodes: 4 on the thorax, 6&#xD;
      on the scapula, 4 on the arm and 1 on the acromio-clavicular joint.&#xD;
&#xD;
      Procedure :&#xD;
&#xD;
        -  Warm up : 2x10 shoulder internal and external rotations&#xD;
&#xD;
        -  Maximum voluntary isometric contraction (MVIC)&#xD;
&#xD;
        -  10 mouvements of abduction (frontal plane) + 10 mouvements of flexion (sagittal plane),&#xD;
           with and without load in each condition (without kinesiotaping, with a first&#xD;
           kinesiotaping technique and with a second kinesiotaping technique). The order of the&#xD;
           different conditions will be randomised.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">April 15, 2019</completion_date>
  <primary_completion_date type="Actual">April 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EMG activity of upper trapezius, lower trapezius and serratus anterior</measure>
    <time_frame>in standard condition and with kinesiotaping (all the same day)</time_frame>
    <description>Measurement with Delsys Trigno (non invasive electrodes)</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Scapular Dyskinesis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesiotaping</intervention_name>
    <description>Mc Connel taping and another kinesiotaping technique</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male dyskinetic sportspeople without shoulder pain, from sportsclub in the Province of&#xD;
        Liege (Belgium)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral or bilateral scapular dyskinesis (visual evaluation, &quot;yes-no method&quot;)&#xD;
&#xD;
          -  scapular downward rotation at rest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  asymmetry of length of lower limbs&#xD;
&#xD;
          -  scoliosis or dorsal hyperkyphosis shoulder surgical history&#xD;
&#xD;
          -  shoulder pain, shoulder injury (muscular, osseous, ligamentary, tendinous) or positive&#xD;
             tendinous and impingement tests (Jobe, Patte 0°, Patte 90°, Lift off Test, Palm-up&#xD;
             Test).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Laboratoire d'Analyse du Mouvement Humain</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>May 3, 2019</last_update_submitted>
  <last_update_submitted_qc>May 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Camille Tooth</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>Dyskinesias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data won't be shared with anyone</ipd_description>
  </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/NCT03821740
org study id: 1
nct id: NCT03821740
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The 3-dimensional position and orientation of the scapula as well as muscle activation of
      upper trapezius (UT), lower trapezius (LT) and serratus anterior (SA) of asymptomatic
      dyskinetic sportspeole will be recorded during shoulder flexion and shoulder abduction, in
      loaded and unloaded conditions. Participants will be assessed in standard condition and with
      two differents kinesiotaping techniques.
About 20 dyskinetic asymptomatic people will be involved in the study. The objective will be
      to compare two different kinesiotaping techniques in normalizing scapular kinematics.

      Tridimensional-movement of the scapula and EMG activity of periscapular muscles will be
      evaluated doing flexion (sagittal plane) and abduction (frontal plane) movements.

      EMG acquisitions :

      The electromyographic (EMG) signals are collected with Trigno Standard and Trigno Mini
      wireless sensors (Delsys, Boston, MA, USA) using silver-contact bipolar bar electrodes with
      ﬁxed 10 mm inter-electrode spacing [49]. Three of the main scapular stabilizing muscles of
      the shoulder are investigated: upper trapezius, lower trapezius and serratus anterior.
      Electrodes are placed on the dyskinetic side. In case of bilateral scapular dyskinesis,
      electrodes are placed on the side where the most important dysfunction was observed. Data are
      acquired at a sample frequency of 1000 Hz.

      Tridimensionnal assessment:

      Scapular kinematics is assessed using a three-dimensional motion analysis system, an
      optoelectronic system based on active markers (Codamotion, Charnwood Dynamic, UK). For that
      purpose, four Codamotion CX1 units are used, at a sampling of 100 Hz. Fifteen active markers
      were placed on the skin of the subject on the same side as EMG electrodes: 4 on the thorax, 6
      on the scapula, 4 on the arm and 1 on the acromio-clavicular joint.

      Procedure :

        -  Warm up : 2x10 shoulder internal and external rotations

        -  Maximum voluntary isometric contraction (MVIC)

        -  10 mouvements of abduction (frontal plane) + 10 mouvements of flexion (sagittal plane),
           with and without load in each condition (without kinesiotaping, with a first
           kinesiotaping technique and with a second kinesiotaping technique). The order of the
           different conditions will be randomised.
observational model: Cohort
time perspective: Cross-Sectional
measure: EMG activity of upper trapezius, lower trapezius and serratus anterior
time frame: in standard condition and with kinesiotaping (all the same day)
description: Measurement with Delsys Trigno (non invasive electrodes)
intervention type: Other
intervention name: Kinesiotaping
description: Mc Connel taping and another kinesiotaping technique
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Camille Tooth
investigator title: Principal Investigator
mesh term: Dyskinesias
sharing ipd: No
ipd description: Data won't be shared with anyone