<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/NCT01733433</url>
  </required_header>
  <id_info>
    <org_study_id>2012/480</org_study_id>
    <nct_id>NCT01733433</nct_id>
  </id_info>
  <brief_title>Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability</brief_title>
  <acronym>CAI</acronym>
  <official_title>Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability (CAI).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main goal of this study is to evaluate the effect of taping on postural control during&#xD;
      dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the&#xD;
      study. Several questionnaires regarding anthropometric data, medical history, activity level&#xD;
      and functional status will be filled in by the participants. Postural control will be&#xD;
      measured using a force plate and an optoelectronic system to capture lower limb kinematics.&#xD;
      Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they&#xD;
      have to maintain their balance for 10 seconds after landing. 5 good trials of each movement&#xD;
      will be captured. Subjects with CAI will perform these exercises with and without tape.&#xD;
      Hypothesis is that subjects with CAI that tape will enhance postural control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2013</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immediate postural control with tape on ankle.</measure>
    <time_frame>for 75 minutes, the duration of the exercises.</time_frame>
    <description>Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective evaluation of the effect of taping on pain</measure>
    <time_frame>1 minute after the exercises (which last approximately 75 minutes).</time_frame>
    <description>Evaluation will be done using a VAS scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective evaluation of the effect of taping on difficulty level.</measure>
    <time_frame>1 minute after the exercises (which last approximately 75 minutes).</time_frame>
    <description>This will be evaluated by interviewing the subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject evaluation of the effect of taping on instability feelings.</measure>
    <time_frame>1 minute after the exercises (which last approximately 75 minutes).</time_frame>
    <description>This will be evaluated by interviewing the subject.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Ankle Instability</condition>
  <arm_group>
    <arm_group_label>taped ankle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be taped in at the ankle for a series of exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Taping the ankle</intervention_name>
    <description>Subjects will be taped in at the ankle for performing several exercises.</description>
    <arm_group_label>taped ankle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a history of at least one ankle sprain which resulted in pain, swelling and stiffness,&#xD;
             prohibiting participation in sport-, recreational or other activities for at least 3&#xD;
             weeks&#xD;
&#xD;
          -  repeated ankle sprains&#xD;
&#xD;
          -  presence of giving way&#xD;
&#xD;
          -  feeling of weakness around the ankle&#xD;
&#xD;
          -  a decreased functional participation (recreational, competitive or professionally)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Roosen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01733433
org study id: 2012/480
nct id: NCT01733433
lead sponsor: 
has dmc: No
The main goal of this study is to evaluate the effect of taping on postural control during
      dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the
      study. Several questionnaires regarding anthropometric data, medical history, activity level
      and functional status will be filled in by the participants. Postural control will be
      measured using a force plate and an optoelectronic system to capture lower limb kinematics.
      Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they
      have to maintain their balance for 10 seconds after landing. 5 good trials of each movement
      will be captured. Subjects with CAI will perform these exercises with and without tape.
      Hypothesis is that subjects with CAI that tape will enhance postural control.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Immediate postural control with tape on ankle.
time frame: for 75 minutes, the duration of the exercises.
description: Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics.
measure: Subjective evaluation of the effect of taping on pain
time frame: 1 minute after the exercises (which last approximately 75 minutes).
description: Evaluation will be done using a VAS scale.
measure: Subjective evaluation of the effect of taping on difficulty level.
time frame: 1 minute after the exercises (which last approximately 75 minutes).
description: This will be evaluated by interviewing the subject.
measure: Subject evaluation of the effect of taping on instability feelings.
time frame: 1 minute after the exercises (which last approximately 75 minutes).
description: This will be evaluated by interviewing the subject.
arm group label: taped ankle
arm group type: Experimental
description: Subjects will be taped in at the ankle for a series of exercises.
intervention type: Procedure
intervention name: Taping the ankle
description: Subjects will be taped in at the ankle for performing several exercises.
arm group label: taped ankle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Philip Roosen, PhD
role: Principal Investigator
affiliation: University Ghent
facility: 
country: Belgium
responsible party type: Sponsor