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/NCT06020131</url>
    </required_header>
    <id_info>
      <org_study_id>ecemnur</org_study_id>
      <nct_id>NCT06020131</nct_id>
    </id_info>
    <brief_title>Effect Of Thoracic Mobility Versus Lumbopelvic Stabilization Exercises On Patients With Chronic Ankle Instability</brief_title>
    <official_title>Effect Of Thoracic Mobility Versus Lumbopelvic Stabilization Exercises On Lower Extremity Flexibility, Dynamic Balance And Proprioception In Patients With Chronic Ankle Instability</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yeditepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yeditepe University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to investigate the effectiveness of thoracic mobility versus&#xD;
        lumbopelvic stabilization exercises combined with ankle strengthening exercises with&#xD;
        resistive band on patients with chronic ankle instability in terms of lower extremity&#xD;
        flexibility, proprioception and dynamic balance.The participants were divided into two group&#xD;
        as Thoracic Mobility group (n=15) and Lumbopelvic Stability group (n=15). In addition their&#xD;
        exercise programs (2 times/wk, 8 wk duration), both groups were given home exercise ankle&#xD;
        strengthening exercises.(3 sets/ 10 reps, 3 times/wk.)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the study is to investigate the effectiveness of thoracic mobility versus&#xD;
        lumbopelvic stabilization exercises combined with ankle strengthening exercises with&#xD;
        resistive band on patients with chronic ankle instability in terms of lower extremity&#xD;
        flexibility, proprioception and dynamic balance. The study were conducted in Noi Physio&#xD;
        Pilates Studio in Istanbul between November 2022 - January 2023 during 8 weeks. 30 volunteers&#xD;
        with chronic ankle instability were included according to Cumberland Ankle Instability Tool&#xD;
        (CAIT). The cut off value for the CAIT test was determined as 27. Participants who received&#xD;
        27 or less than this value were included in the study. All participants were right dominant.&#xD;
        Lower extremity flexibility was assessed with Active Straight Leg Raise Test, proprioception&#xD;
        (hip, knee, ankle) was assessed with Joint Position Sense Test using electronic goniometer.&#xD;
        Determined angles for joints; hip flexion angle as 75°, knee flexion angle as 50° and ankle&#xD;
        dorsiflexion as 10° plantarflexion as 40°.Y Balance Test (anterior, posterolateral,&#xD;
        posteromedial) was used for evaluating dynamic balance. 30 participants were divided into two&#xD;
        groups as thoracic mobility and lumbopelvic stability group. Both groups were given ankle&#xD;
        strengthening exercises (dorsiflexion, plantarflexion, inversion and eversion) with resistive&#xD;
        band. Home exercises were performed 3 days a week for a total of 3 sets of 10 repetitions.&#xD;
        Thoracic mobility group was given; thoracic extension on foam roller, sidelying thoracic&#xD;
        rotation, quadruped thoracic rotation, squat with extension and rotation. Lumbopelvic&#xD;
        stabilization group was prescribed; bridge with alternate leg, single leg bridge, four point&#xD;
        kneeling with arm and leg extension, side plank on front arm with knee flexed (right, left),&#xD;
        sitting on a Swiss Ball and hip flexion.Sessions took approximately 50 minutes and exercise&#xD;
        program was planned twice a week for 8 weeks, 16 sessions total. Both groups were given ankle&#xD;
        strengthening exercises (dorsiflexion, plantarflexion, inversion and eversion) with resistive&#xD;
        band. Home exercises were performed 3 days a week for a total of 3 sets of 10 repetitions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Actual">January 15, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2023</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>Parallel Assignment</intervention_model>
      <intervention_model_description>The sample of study consist of patients with chronic ankle instability who gets 27 and less point from Cumberland Ankle Instability Tool. The study was conducted between November 2022 - January 2023 in Noi Physio Pilates Studio in İstanbul.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cumberland Ankle Instability Tool (CAIT)</measure>
      <time_frame>8 weeks</time_frame>
      <description>CAIT is questionnaire' has 9 items with scores ranging from 0 to 30, with lower scores indicating worse stability</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Active Straight Leg Raise Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>It is used for evaluation of lower extremity flexibility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Y Balance Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>Dynamic balance test for right and left leg including three directions (anterior, posterolateral, posteromedial)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Joint Position Sense Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>It is a test for measuring proprioception of joints. (Hip, knee, ankle)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Chronic Ankle Instability</condition>
    <arm_group>
      <arm_group_label>Thoracic Mobility Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Thoracic Mobility Exercises Ankle Strengthening Home Exercises with resistive band</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lumbopelvic Stability Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lumbopelvic stabilization exercises Ankle Strengthening Home Exercises with resistive band</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Thoracic Mobility Rehabilitation</intervention_name>
      <description>Thoracic mobility exercises: Thoracic extension on foam roller, Sidelying thoracic rotation, Quadruped thoracic rotation, Squat with extension and rotation ( 10 reps x 3 set - 2 times x wk - 8 wk)</description>
      <arm_group_label>Thoracic Mobility Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Lumbopelvic Stability Rehabilitation</intervention_name>
      <description>Lumbopelvic Stabilization Exercises : Bridge with alternate leg, Single leg bridge, Four point kneeling with arm and leg extension, Side plank on front arm with knee flexed (right, left), Sitting on a Swiss Ball and hip flexion (10 reps x 3 set - 2times/wk - 8 wk)</description>
      <arm_group_label>Lumbopelvic Stability Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Ankle Strengthening Home Exercises</intervention_name>
      <description>Ankle Strengthening exercises with resistive band (dorsiflexion, plantarflexion, inversion, eversion) (10 reps x 3 set - 3 times/wk)</description>
      <arm_group_label>Lumbopelvic Stability Group</arm_group_label>
      <arm_group_label>Thoracic Mobility Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being older than 18 years&#xD;
  &#xD;
            -  Having at least two previous lateral ankle sprain of same ankle.&#xD;
  &#xD;
            -  At least one episode of &quot;giving way&quot; wtihin previous 6 months.&#xD;
  &#xD;
            -  Having persistent symptoms during functional activities and being free of.&#xD;
  &#xD;
            -  Symptoms from any previous lower limb injuries.&#xD;
  &#xD;
            -  No other lower extremity injuries.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having any systemic illness (eg. Rheumatoid arthritis, DM).&#xD;
  &#xD;
            -  Any surgery history related to fractures or disorders.&#xD;
  &#xD;
            -  Getting steroid injection or physiotherapy intervention previous 6 months.&#xD;
  &#xD;
            -  Being a pregnant and existence of tumor.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ecem Nur TAKINDI, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yeditepe University, Institute of Health Science, Sports Physiotherapy Department</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Elif Tuğçe ÇİL, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Yeditepe University, Institute of Health Science, Sports Physiotherapy Department</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Noi Physio Pilates Studio</name>
        <address>
          <city>Istanbul</city>
          <state>Ataşehir</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>chronic ankle instability</keyword>
    <keyword>dynamic balance</keyword>
    <keyword>proprioception</keyword>
    <keyword>flexibility</keyword>
    <keyword>thoracic mobility</keyword>
    <keyword>lumbopelvic stability</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Participants were included to study accorcing to Informed Consent Form (ICF). Datas and informations were recorded.</ipd_description>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>8 week</ipd_time_frame>
      <ipd_access_criteria>Informed consent form was used for gathering demographic information from participants. Cumberland Ankle Instability Tool (CAIT) was used for assesing chronic ankle instability. Cut off value was determined as ≤27 points.</ipd_access_criteria>
    </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/NCT06020131
  org study id: ecemnur
  nct id: NCT06020131
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to investigate the effectiveness of thoracic mobility versus
        lumbopelvic stabilization exercises combined with ankle strengthening exercises with
        resistive band on patients with chronic ankle instability in terms of lower extremity
        flexibility, proprioception and dynamic balance.The participants were divided into two group
        as Thoracic Mobility group (n=15) and Lumbopelvic Stability group (n=15). In addition their
        exercise programs (2 times/wk, 8 wk duration), both groups were given home exercise ankle
        strengthening exercises.(3 sets/ 10 reps, 3 times/wk.)
  The aim of the study is to investigate the effectiveness of thoracic mobility versus
        lumbopelvic stabilization exercises combined with ankle strengthening exercises with
        resistive band on patients with chronic ankle instability in terms of lower extremity
        flexibility, proprioception and dynamic balance. The study were conducted in Noi Physio
        Pilates Studio in Istanbul between November 2022 - January 2023 during 8 weeks. 30 volunteers
        with chronic ankle instability were included according to Cumberland Ankle Instability Tool
        (CAIT). The cut off value for the CAIT test was determined as 27. Participants who received
        27 or less than this value were included in the study. All participants were right dominant.
        Lower extremity flexibility was assessed with Active Straight Leg Raise Test, proprioception
        (hip, knee, ankle) was assessed with Joint Position Sense Test using electronic goniometer.
        Determined angles for joints; hip flexion angle as 75°, knee flexion angle as 50° and ankle
        dorsiflexion as 10° plantarflexion as 40°.Y Balance Test (anterior, posterolateral,
        posteromedial) was used for evaluating dynamic balance. 30 participants were divided into two
        groups as thoracic mobility and lumbopelvic stability group. Both groups were given ankle
        strengthening exercises (dorsiflexion, plantarflexion, inversion and eversion) with resistive
        band. Home exercises were performed 3 days a week for a total of 3 sets of 10 repetitions.
        Thoracic mobility group was given; thoracic extension on foam roller, sidelying thoracic
        rotation, quadruped thoracic rotation, squat with extension and rotation. Lumbopelvic
        stabilization group was prescribed; bridge with alternate leg, single leg bridge, four point
        kneeling with arm and leg extension, side plank on front arm with knee flexed (right, left),
        sitting on a Swiss Ball and hip flexion.Sessions took approximately 50 minutes and exercise
        program was planned twice a week for 8 weeks, 16 sessions total. Both groups were given ankle
        strengthening exercises (dorsiflexion, plantarflexion, inversion and eversion) with resistive
        band. Home exercises were performed 3 days a week for a total of 3 sets of 10 repetitions.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The sample of study consist of patients with chronic ankle instability who gets 27 and less point from Cumberland Ankle Instability Tool. The study was conducted between November 2022 - January 2023 in Noi Physio Pilates Studio in İstanbul.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Cumberland Ankle Instability Tool (CAIT)
  time frame: 8 weeks
  description: CAIT is questionnaire' has 9 items with scores ranging from 0 to 30, with lower scores indicating worse stability
  measure: Active Straight Leg Raise Test
  time frame: 8 weeks
  description: It is used for evaluation of lower extremity flexibility.
  measure: Y Balance Test
  time frame: 8 weeks
  description: Dynamic balance test for right and left leg including three directions (anterior, posterolateral, posteromedial)
  measure: Joint Position Sense Test
  time frame: 8 weeks
  description: It is a test for measuring proprioception of joints. (Hip, knee, ankle)
  arm group label: Thoracic Mobility Group
  arm group type: Experimental
  description: Thoracic Mobility Exercises Ankle Strengthening Home Exercises with resistive band
  arm group label: Lumbopelvic Stability Group
  arm group type: Experimental
  description: Lumbopelvic stabilization exercises Ankle Strengthening Home Exercises with resistive band
  intervention type: Procedure
  intervention name: Thoracic Mobility Rehabilitation
  description: Thoracic mobility exercises: Thoracic extension on foam roller, Sidelying thoracic rotation, Quadruped thoracic rotation, Squat with extension and rotation ( 10 reps x 3 set - 2 times x wk - 8 wk)
  arm group label: Thoracic Mobility Group
  intervention type: Procedure
  intervention name: Lumbopelvic Stability Rehabilitation
  description: Lumbopelvic Stabilization Exercises : Bridge with alternate leg, Single leg bridge, Four point kneeling with arm and leg extension, Side plank on front arm with knee flexed (right, left), Sitting on a Swiss Ball and hip flexion (10 reps x 3 set - 2times/wk - 8 wk)
  arm group label: Lumbopelvic Stability Group
  intervention type: Procedure
  intervention name: Ankle Strengthening Home Exercises
  description: Ankle Strengthening exercises with resistive band (dorsiflexion, plantarflexion, inversion, eversion) (10 reps x 3 set - 3 times/wk)
  arm group label: Lumbopelvic Stability Group
  arm group label: Thoracic Mobility Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Ecem Nur TAKINDI, MSc
  role: Principal Investigator
  affiliation: Yeditepe University, Institute of Health Science, Sports Physiotherapy Department
  last name: Elif Tuğçe ÇİL, PhD
  role: Study Director
  affiliation: Yeditepe University, Institute of Health Science, Sports Physiotherapy Department
  facility: 
  country: Turkey
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  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Participants were included to study accorcing to Informed Consent Form (ICF). Datas and informations were recorded.
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 8 week
  ipd access criteria: Informed consent form was used for gathering demographic information from participants. Cumberland Ankle Instability Tool (CAIT) was used for assesing chronic ankle instability. Cut off value was determined as ≤27 points.