xml: <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/NCT06024070</url>
    </required_header>
    <id_info>
      <org_study_id>012/003958</org_study_id>
      <nct_id>NCT06024070</nct_id>
    </id_info>
    <brief_title>Effect of Rigid Tapping on Chronic Functional Ankle Instability in Basketball Players</brief_title>
    <official_title>Effect of Rigid Tapping on Chronic Functional Ankle Instability in Basketball Players</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</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>
        This study aims rigid tapping on chronic functional ankle instability in professional&#xD;
        basketball players.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lateral ankle sprains (LASs) are common injuries in sports and physical activities, with up&#xD;
        to 40% of individuals experiencing a first-time LAS developing chronic ankle instability&#xD;
        (CAI). LASs predominantly affect the anterior talofibular ligament, and residual symptoms can&#xD;
        persist in a significant percentage of patients. However, many individuals with ankle sprains&#xD;
        do not seek professional treatment, leading to potential underestimation of the injury&#xD;
        severity. CAI is characterized by recurrent episodes of ankle giving way, ongoing symptoms,&#xD;
        reduced ankle range of motion, diminished self-reported function, and persistent ankle&#xD;
        sprains beyond one year. It is attributed to both mechanical and functional instability, with&#xD;
        factors such as proprioceptive deficits and mechanical insufficiencies contributing to the&#xD;
        condition. Taping, particularly rigid taping, is commonly used by athletes to enhance joint&#xD;
        stability and improve dynamic balance and functional performance. Rigid taping limits joint&#xD;
        movement, improves joint position, and provides external support without compromising&#xD;
        functional performance. Taping is especially prevalent in multidirectional sports like&#xD;
        basketball, where ankle sprains are frequent. The use of tapes aims to restrict ankle&#xD;
        movement, increase joint stability, and enhance proprioception without hindering athletic&#xD;
        performance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 12, 2022</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">April 10, 2023</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>
      <intervention_model_description>pre post study design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Ankle Stability</measure>
      <time_frame>3 days</time_frame>
      <description>measured by y balance test and single leg stance test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>functional performance</measure>
      <time_frame>3 days</time_frame>
      <description>measured by Figure of 8 hopping test</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">28</enrollment>
    <condition>Ankle Inversion Sprain</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>this study group assessed by 3 functional tests (Figure of 8 hopping , single leg stance test and y balance test) pre and post receiving rigid ankle tapping</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rigid Tape</intervention_name>
      <description>The patient was rested in supine or long sitting position on a table Pre-wrap was applied to cover all the area before tapping Two strips used separately as anchors at the two ends of the pre-wrap. Two Longitudinal stirrup of tape were used from medial side of the superior anchor to lateral side of the same anchor.&#xD;
  Two horizontal stirrup of tape were used from medial side of the distal anchor to lateral side of the same anchor to support the medial side of the foot.&#xD;
  Figure-of-eight straps were utilized for the taping. Lateral heel lock was applied.The tape then proceeded from the lateral side of the foot, looping around the heel, and returning to the same starting point by crossing over the Achilles tendon from behind.&#xD;
  Medial heel lock was applied, the tape application was similar to the lateral heel lock but was at the opposite direction.&#xD;
  Superior and inferior anchors were applied to support all the previous strips</description>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1- Basketball players with age range from 18-40 years old. 2- Body mass index (BMI)&#xD;
               range from 18-25 H/m2. 3- Participants had episodes of subjective sensation of&#xD;
               instability in the last six months 4- Participants have at least moderate ankle&#xD;
               instability, defined as a score of &lt;25 on the Cumberland Ankle Instability Tool (CAIT)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1- Participants had a history of surgery or fractures in the ankle joints 2-&#xD;
               Participants had a neurological or vestibular disorder 3- Participants were unable to&#xD;
               understand the nature of the protocol and test instructions&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Salwa Fa Abdel-Majeed, phd</last_name>
      <role>Study Chair</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of physical therapy</name>
        <address>
          <city>Giza</city>
          <zip>12613</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Islam Gomaa Mohamed Eid</investigator_full_name>
      <investigator_title>physiotherapist</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024070
  org study id: 012/003958
  nct id: NCT06024070
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aims rigid tapping on chronic functional ankle instability in professional
        basketball players.
  Lateral ankle sprains (LASs) are common injuries in sports and physical activities, with up
        to 40% of individuals experiencing a first-time LAS developing chronic ankle instability
        (CAI). LASs predominantly affect the anterior talofibular ligament, and residual symptoms can
        persist in a significant percentage of patients. However, many individuals with ankle sprains
        do not seek professional treatment, leading to potential underestimation of the injury
        severity. CAI is characterized by recurrent episodes of ankle giving way, ongoing symptoms,
        reduced ankle range of motion, diminished self-reported function, and persistent ankle
        sprains beyond one year. It is attributed to both mechanical and functional instability, with
        factors such as proprioceptive deficits and mechanical insufficiencies contributing to the
        condition. Taping, particularly rigid taping, is commonly used by athletes to enhance joint
        stability and improve dynamic balance and functional performance. Rigid taping limits joint
        movement, improves joint position, and provides external support without compromising
        functional performance. Taping is especially prevalent in multidirectional sports like
        basketball, where ankle sprains are frequent. The use of tapes aims to restrict ankle
        movement, increase joint stability, and enhance proprioception without hindering athletic
        performance.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: pre post study design
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Ankle Stability
  time frame: 3 days
  description: measured by y balance test and single leg stance test
  measure: functional performance
  time frame: 3 days
  description: measured by Figure of 8 hopping test
  arm group label: study group
  arm group type: Experimental
  description: this study group assessed by 3 functional tests (Figure of 8 hopping , single leg stance test and y balance test) pre and post receiving rigid ankle tapping
  intervention type: Other
  intervention name: Rigid Tape
  description: The patient was rested in supine or long sitting position on a table Pre-wrap was applied to cover all the area before tapping Two strips used separately as anchors at the two ends of the pre-wrap. Two Longitudinal stirrup of tape were used from medial side of the superior anchor to lateral side of the same anchor.
  Two horizontal stirrup of tape were used from medial side of the distal anchor to lateral side of the same anchor to support the medial side of the foot.
  Figure-of-eight straps were utilized for the taping. Lateral heel lock was applied.The tape then proceeded from the lateral side of the foot, looping around the heel, and returning to the same starting point by crossing over the Achilles tendon from behind.
  Medial heel lock was applied, the tape application was similar to the lateral heel lock but was at the opposite direction.
  Superior and inferior anchors were applied to support all the previous strips
  arm group label: study group
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Salwa Fa Abdel-Majeed, phd
  role: Study Chair
  affiliation: Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Islam Gomaa Mohamed Eid
  investigator title: physiotherapist
  sharing ipd: No