<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/NCT03815526</url>
  </required_header>
  <id_info>
    <org_study_id>N201811015</org_study_id>
    <nct_id>NCT03815526</nct_id>
  </id_info>
  <brief_title>The Immediate Effects of Applying Dynamic Tape, Kinesio Tape and Sport Tape With Chronic Ankle Instability</brief_title>
  <official_title>The Immediate Effects of Applying Dynamic Tape, Kinesio Tape and Sport Tape With Chronic Ankle Instability</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>
      Injuries to the ankle joint account for 20% of the population that is afﬂicted with joint&#xD;
      injury and the largest percentage of self-reported musculoskeletal injuries (&gt; 10%) are to&#xD;
      the ankle. Ankle sprain has a large portion in ankle injuries and occurs not only in the&#xD;
      sporting population but also in the general community. Although the acute symptom would be&#xD;
      resolve quickly, but many people still report persisting problems, such as pain and&#xD;
      instability. Chronic ankle instability (CAI) is one of the most common of these residual&#xD;
      problems.&#xD;
&#xD;
      Kinesio Tape and White Duck Tape are often applied in patients with CAI, attempt to increase&#xD;
      the ankle joint stability, and improve motor performance. However, the previous studies had&#xD;
      controversial result to the effects of kinesio tape and white duck tape. The previous studies&#xD;
      also showed the insufficient of supporting force and elasticity of kinesio tape and white&#xD;
      duct tape. The Dynamic Tape was developed by Kendrick in 2009, which refined the&#xD;
      characteristic of elasticity and supporting force.&#xD;
&#xD;
      Therefore the purpose of study is to comparison the effects of static and dynamic balance&#xD;
      performance, weight shifting ability and functional movement between kinesio tape, white duck&#xD;
      tape and dynamic tape when applied on patients with CAI. With the result may provide an&#xD;
      optical method to increase the movement performance of patients with CAI.&#xD;
&#xD;
      The study suspected to recruit 90 volunteers with CAI, and randomly divided to three&#xD;
      different groups: Kinesio tape group, White duck tape group and Dynamic tape group. We make&#xD;
      postural stability test and limit postural stability test with Biodex Balance System (SD),&#xD;
      Y-balance test and single leg hop test to both affected side and sound side foot before&#xD;
      applying the tape. After applying the tape according to the divided group, we will repeat the&#xD;
      test above again. We will compare the results of the test between groups and within groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 10, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biodex Balance System</measure>
    <time_frame>1 day</time_frame>
    <description>Overall Stability Index, Anterior/Posterior Index, Medial/Lateral Index Limits of stability direction control score (Overall, Forward, Backward, Right, Left, Forward/Right, Forward/Left, Backward/Right, Backward/Left)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Y-balance test</measure>
    <time_frame>1 day</time_frame>
    <description>dynamic reach (cm): anterior, posterior/medial, posterior/lateral</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single leg hop test</measure>
    <time_frame>1 day</time_frame>
    <description>single leg hop laterally distance (cm) and 15 cm side hop time(second)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Taping</condition>
  <condition>Ankle Sprains</condition>
  <arm_group>
    <arm_group_label>Dynamic tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesio tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sport tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dynamic tape</intervention_name>
    <description>Dynamic tape apply 1 time</description>
    <arm_group_label>Dynamic tape</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesio tape</intervention_name>
    <description>Dynamic tape apply 1 time</description>
    <arm_group_label>Kinesio tape</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sport tape</intervention_name>
    <description>Dynamic tape apply 1 time</description>
    <arm_group_label>Sport tape</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A history of at least one signiﬁcant ankle sprain&#xD;
&#xD;
               -  The initial sprain must have occurred at least 12 months prior to the study&#xD;
                  enrolment&#xD;
&#xD;
               -  Was associated with inﬂammatory symptoms (pain, swelling, etc)&#xD;
&#xD;
               -  Created at least one interrupted day of desired physical activity&#xD;
&#xD;
          2. A history of the previously injured ankle joint 'giving way' , and /or recurrent&#xD;
             sprain and/or 'feelings of instability'.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of previous surgeries to the musculoskeletal structures (ie, bones, joint&#xD;
             structures and nerves) in either lower extremity.&#xD;
&#xD;
          2. A history of a fracture in either lower extremity requiring realignment.&#xD;
&#xD;
          3. Acute injury to the musculoskeletal structures of other joints of the lower extremity&#xD;
             in the previous 1 months, which impacted joint integrity and function (ie, sprains,&#xD;
             fractures) resulting in at least 1 interrupted day of desired physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chien-Yung CY Wang, MS</last_name>
    <phone>+886-229307930</phone>
    <phone_ext>1624</phone_ext>
    <email>106021@w.tmu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wanfang Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>116</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chien-Yung Wang</last_name>
      <phone>0229307930</phone>
      <phone_ext>1624</phone_ext>
      <email>106021@w.tmu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DynamicTape</keyword>
  <keyword>Sport Tape</keyword>
  <keyword>Kinesio Tape</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ankle Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03815526
org study id: N201811015
nct id: NCT03815526
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Injuries to the ankle joint account for 20% of the population that is afﬂicted with joint
      injury and the largest percentage of self-reported musculoskeletal injuries (> 10%) are to
      the ankle. Ankle sprain has a large portion in ankle injuries and occurs not only in the
      sporting population but also in the general community. Although the acute symptom would be
      resolve quickly, but many people still report persisting problems, such as pain and
      instability. Chronic ankle instability (CAI) is one of the most common of these residual
      problems.

      Kinesio Tape and White Duck Tape are often applied in patients with CAI, attempt to increase
      the ankle joint stability, and improve motor performance. However, the previous studies had
      controversial result to the effects of kinesio tape and white duck tape. The previous studies
      also showed the insufficient of supporting force and elasticity of kinesio tape and white
      duct tape. The Dynamic Tape was developed by Kendrick in 2009, which refined the
      characteristic of elasticity and supporting force.

      Therefore the purpose of study is to comparison the effects of static and dynamic balance
      performance, weight shifting ability and functional movement between kinesio tape, white duck
      tape and dynamic tape when applied on patients with CAI. With the result may provide an
      optical method to increase the movement performance of patients with CAI.

      The study suspected to recruit 90 volunteers with CAI, and randomly divided to three
      different groups: Kinesio tape group, White duck tape group and Dynamic tape group. We make
      postural stability test and limit postural stability test with Biodex Balance System (SD),
      Y-balance test and single leg hop test to both affected side and sound side foot before
      applying the tape. After applying the tape according to the divided group, we will repeat the
      test above again. We will compare the results of the test between groups and within groups.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Biodex Balance System
time frame: 1 day
description: Overall Stability Index, Anterior/Posterior Index, Medial/Lateral Index Limits of stability direction control score (Overall, Forward, Backward, Right, Left, Forward/Right, Forward/Left, Backward/Right, Backward/Left)
measure: Y-balance test
time frame: 1 day
description: dynamic reach (cm): anterior, posterior/medial, posterior/lateral
measure: Single leg hop test
time frame: 1 day
description: single leg hop laterally distance (cm) and 15 cm side hop time(second)
arm group label: Dynamic tape
arm group type: Experimental
arm group label: Kinesio tape
arm group type: Experimental
arm group label: Sport tape
arm group type: Experimental
intervention type: Other
intervention name: Dynamic tape
description: Dynamic tape apply 1 time
arm group label: Dynamic tape
intervention type: Other
intervention name: Kinesio tape
description: Dynamic tape apply 1 time
arm group label: Kinesio tape
intervention type: Other
intervention name: Sport tape
description: Dynamic tape apply 1 time
arm group label: Sport tape
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chien-Yung CY Wang, MS
phone: +886-229307930
phone ext: 1624
email: 106021@w.tmu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Ankle Injuries