<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/NCT04487184</url>
  </required_header>
  <id_info>
    <org_study_id>TYGH107038</org_study_id>
    <nct_id>NCT04487184</nct_id>
  </id_info>
  <brief_title>Effect of the Different Methods of Kinesiology Taping on the Muscle Contraction Performance of Fatigued Biceps Brachii</brief_title>
  <official_title>Effect of the Different Methods of Kinesiology Taping on the Muscle Contraction Performance of Fatigued Biceps Brachii</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taoyuan General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taoyuan General 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>
      Recently, kinesiology tape is a common intervention in clinic and sport. According to the&#xD;
      theory mentioned by the founder (Dr. Kenzo Kase), the elasticity of kinesiology tape has&#xD;
      different effects from different taping skill. For muscle and fascia, taping could promote or&#xD;
      inhibit contraction of muscle. For skeletal system, the intervention could correct posture&#xD;
      and improve movement pattern through limiting joint mobility. For swelling, it may increase&#xD;
      circulation of lymph during acute stage. However, whether these theories are feasible are&#xD;
      still controversial in most studies.&#xD;
&#xD;
      The differences between results may be related to the high heterogeneity of taping method and&#xD;
      outcome measures. On the other hand, there are lack of studies with high quality. The&#xD;
      differences of taping method and skill should be considered for investigating the effect of&#xD;
      kinesiology tape. And the performance of muscle contraction should be assessed by accurate&#xD;
      instruments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Double-blind and crossover study design will be used in this study. The taping method is&#xD;
      divided into 4 types: Tradition (from origin to insertion), Cross, New (from insertion to&#xD;
      origin) and Control (non-taping). The order of types will be assigned to subjects randomly.&#xD;
      The 4 types of taping will be applied in 2 days that one week apart. Ultimate physical&#xD;
      rehabilitation system (Pris RS, BTE, USA) will be used to access the differences of muscle&#xD;
      strength and muscular endurance between different taping skills. The aims are to investigate&#xD;
      the effect of the different method of kinesiology tape on performance of fatigued biceps&#xD;
      brachii.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Actual">September 26, 2019</completion_date>
  <primary_completion_date type="Actual">September 26, 2019</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 Maximal Isometric Contraction Strength</measure>
    <time_frame>Pre and immediately post test</time_frame>
    <description>Ultimate physical rehabilitation system (Pris RS, BTE, USA) will be used to access the outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Peak Contraction Speed</measure>
    <time_frame>Pre and immediately post test</time_frame>
    <description>Ultimate physical rehabilitation system (Pris RS, BTE, USA) will be used to access the outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Maximal 10-s Power</measure>
    <time_frame>Pre and immediately post test</time_frame>
    <description>Ultimate physical rehabilitation system (Pris RS, BTE, USA) will be used to access the outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Isokinetic Contraction Work</measure>
    <time_frame>Pre and immediately post test</time_frame>
    <description>Ultimate physical rehabilitation system (Pris RS, BTE, USA) will be used to access the outcome</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Muscle Fatigue</condition>
  <arm_group>
    <arm_group_label>Facilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>From origin to insertion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>From insertion to origin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cross the muscle fiber</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>No tape</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesiology taping</intervention_name>
    <description>Recently, kinesiology tape is a common intervention in clinic and sport. The tension caused by tape elasticity and attachment techniques affects the effects that kinesiology tape produces, such as pain relief, circulation increase, proprioception enhancement, and muscle contraction improvement.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Cross</arm_group_label>
    <arm_group_label>Facilitation</arm_group_label>
    <arm_group_label>Relaxation</arm_group_label>
    <other_name>Kinesio tape</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adults aged 20 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who were unable to follow verbal instructions, had open wounds, or were allergic&#xD;
             to kinesiology tape were excluded.&#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>
  <overall_official>
    <last_name>Wu Ruo-Yan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taoyuan General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taoyuan General Hospital, Ministry of Health and Welfare</name>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Choi IR, Lee JH. Effect of kinesiology tape application direction on quadriceps strength. Medicine (Baltimore). 2018 Jun;97(24):e11038. doi: 10.1097/MD.0000000000011038.</citation>
    <PMID>29901599</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kinesiology tape</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Muscle contraction performance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The datasets generated or analyzed during the current study are available from the corresponding author on reasonable request.</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/NCT04487184
org study id: TYGH107038
nct id: NCT04487184
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Recently, kinesiology tape is a common intervention in clinic and sport. According to the
      theory mentioned by the founder (Dr. Kenzo Kase), the elasticity of kinesiology tape has
      different effects from different taping skill. For muscle and fascia, taping could promote or
      inhibit contraction of muscle. For skeletal system, the intervention could correct posture
      and improve movement pattern through limiting joint mobility. For swelling, it may increase
      circulation of lymph during acute stage. However, whether these theories are feasible are
      still controversial in most studies.

      The differences between results may be related to the high heterogeneity of taping method and
      outcome measures. On the other hand, there are lack of studies with high quality. The
      differences of taping method and skill should be considered for investigating the effect of
      kinesiology tape. And the performance of muscle contraction should be assessed by accurate
      instruments.
Double-blind and crossover study design will be used in this study. The taping method is
      divided into 4 types: Tradition (from origin to insertion), Cross, New (from insertion to
      origin) and Control (non-taping). The order of types will be assigned to subjects randomly.
      The 4 types of taping will be applied in 2 days that one week apart. Ultimate physical
      rehabilitation system (Pris RS, BTE, USA) will be used to access the differences of muscle
      strength and muscular endurance between different taping skills. The aims are to investigate
      the effect of the different method of kinesiology tape on performance of fatigued biceps
      brachii.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from Baseline Maximal Isometric Contraction Strength
time frame: Pre and immediately post test
description: Ultimate physical rehabilitation system (Pris RS, BTE, USA) will be used to access the outcome
measure: Change from Baseline Peak Contraction Speed
time frame: Pre and immediately post test
description: Ultimate physical rehabilitation system (Pris RS, BTE, USA) will be used to access the outcome
measure: Change from Baseline Maximal 10-s Power
time frame: Pre and immediately post test
description: Ultimate physical rehabilitation system (Pris RS, BTE, USA) will be used to access the outcome
measure: Change from Baseline Isokinetic Contraction Work
time frame: Pre and immediately post test
description: Ultimate physical rehabilitation system (Pris RS, BTE, USA) will be used to access the outcome
arm group label: Facilitation
arm group type: Active Comparator
description: From origin to insertion
arm group label: Relaxation
arm group type: Experimental
description: From insertion to origin
arm group label: Cross
arm group type: Placebo Comparator
description: Cross the muscle fiber
arm group label: Control
arm group type: Sham Comparator
description: No tape
intervention type: Other
intervention name: Kinesiology taping
description: Recently, kinesiology tape is a common intervention in clinic and sport. The tension caused by tape elasticity and attachment techniques affects the effects that kinesiology tape produces, such as pain relief, circulation increase, proprioception enhancement, and muscle contraction improvement.
arm group label: Control
arm group label: Cross
arm group label: Facilitation
arm group label: Relaxation
other name: Kinesio tape
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wu Ruo-Yan
role: Principal Investigator
affiliation: Taoyuan General Hospital
facility: 
country: Taiwan
citation: Choi IR, Lee JH. Effect of kinesiology tape application direction on quadriceps strength. Medicine (Baltimore). 2018 Jun;97(24):e11038. doi: 10.1097/MD.0000000000011038.
PMID: 29901599
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: No
ipd description: The datasets generated or analyzed during the current study are available from the corresponding author on reasonable request.