<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/NCT04504929</url>
  </required_header>
  <id_info>
    <org_study_id>N201912094</org_study_id>
    <nct_id>NCT04504929</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Dynamic Taping in Preventing Muscle Fatigue</brief_title>
  <official_title>The Effectiveness of Dynamic Taping in Preventing Muscle Fatigue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang Hospital</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 this study is to assess the efficacy of dynamic tape in prevent shoulder&#xD;
      muscle fatigue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study and the potential of risk, all participants will undergo&#xD;
      a screening to determine eligibility for study entry and giving written informed consent.&#xD;
&#xD;
      We will include 20 participants who have pitch 100 times with dynamic taping or shame taping&#xD;
      in randomized sequence. There must be more than 2 weeks resting between 2 test. We will test&#xD;
      maximal force in shoulder flexion, extension, abduction and adduction before and after test.&#xD;
      We also record spins and speed of baseball for performance outcome.&#xD;
&#xD;
      To our hypothesis, we suggest dynamic taping could decrease the arm fatigue after long-term&#xD;
      pitching.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in shoulder force after pitching</measure>
    <time_frame>baseline and 2 weeks</time_frame>
    <description>The dynamometer is a validated instrument assessing shoulder and arm force which is recorded in kilogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of pitching velocity during pitching</measure>
    <time_frame>baseline and 2 weeks</time_frame>
    <description>The speed dun is a validated instrument assessing pitching velocity which is recorded in kilometer per hour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of pitching spin rate during pitching</measure>
    <time_frame>baseline and 2 weeks</time_frame>
    <description>The STRIKE baseball is a new instrument assessing pitching spin rate and axis which is recorded in rate per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of delayed onset muscle soreness after pitching</measure>
    <time_frame>baseline, 1 Day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days</time_frame>
    <description>Visual analog scale is a validated self-record measure to assess delayed onset muscle soreness, which score range is 0 to 10.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Fatigue; Muscle, Heart</condition>
  <condition>Shoulder Pain</condition>
  <condition>Sport Injury</condition>
  <arm_group>
    <arm_group_label>Sham tape</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>participants received sham taping during pitching, and removed after pitching</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dynamic tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants received dynamic taping during pitching, and removed after pitching</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tape</intervention_name>
    <description>Use sham type on the pitching shoulder</description>
    <arm_group_label>Sham tape</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamic tape</intervention_name>
    <description>Use dynamic type on the pitching shoulder for supporting internal rotation</description>
    <arm_group_label>Dynamic tape</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more than 20 years old&#xD;
&#xD;
          -  amateur baseball player&#xD;
&#xD;
          -  could tolerate pitching 100 times&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  shoulder pain who could not tolerate 100 pitching&#xD;
&#xD;
          -  upper limb surgery history&#xD;
&#xD;
          -  Allergy to topical agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Athletic Injuries</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/NCT04504929
org study id: N201912094
nct id: NCT04504929
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the efficacy of dynamic tape in prevent shoulder
      muscle fatigue.
After being informed about the study and the potential of risk, all participants will undergo
      a screening to determine eligibility for study entry and giving written informed consent.

      We will include 20 participants who have pitch 100 times with dynamic taping or shame taping
      in randomized sequence. There must be more than 2 weeks resting between 2 test. We will test
      maximal force in shoulder flexion, extension, abduction and adduction before and after test.
      We also record spins and speed of baseball for performance outcome.

      To our hypothesis, we suggest dynamic taping could decrease the arm fatigue after long-term
      pitching.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline in shoulder force after pitching
time frame: baseline and 2 weeks
description: The dynamometer is a validated instrument assessing shoulder and arm force which is recorded in kilogram
measure: Change of pitching velocity during pitching
time frame: baseline and 2 weeks
description: The speed dun is a validated instrument assessing pitching velocity which is recorded in kilometer per hour
measure: Change of pitching spin rate during pitching
time frame: baseline and 2 weeks
description: The STRIKE baseball is a new instrument assessing pitching spin rate and axis which is recorded in rate per minute
measure: Change of delayed onset muscle soreness after pitching
time frame: baseline, 1 Day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days
description: Visual analog scale is a validated self-record measure to assess delayed onset muscle soreness, which score range is 0 to 10.
arm group label: Sham tape
arm group type: Sham Comparator
description: participants received sham taping during pitching, and removed after pitching
arm group label: Dynamic tape
arm group type: Experimental
description: participants received dynamic taping during pitching, and removed after pitching
intervention type: Device
intervention name: Sham tape
description: Use sham type on the pitching shoulder
arm group label: Sham tape
intervention type: Device
intervention name: Dynamic tape
description: Use dynamic type on the pitching shoulder for supporting internal rotation
arm group label: Dynamic tape
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Fatigue
mesh term: Athletic Injuries
sharing ipd: Undecided