<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200617047818N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-05</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Comparison of The Effect of Wobble board training with and without Cognitive intervention on the active men with chronic ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of The Effect of a period Wobble Board training with and without Cognitive intervention on balance, ankle proprioception, and some jump landing kinetic parameters of the active men with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52450</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized into one of three groups (Two intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope, Blinding description: In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Chronic ankle instability. Condition 2: Athlete.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For 5 weeks, three sessions per week, 5 sets, each set 40 seconds, every 10 seconds to rotate alternately, one minute rest between each set, standing in three positions: standing, standing on non-engaged leg, and standing on foot Involved, wobble board exercises. Intervention 2: Intervention group: For 5 weeks, three sessions per week, 5 sets, each set 40 seconds, every 10 seconds to rotate alternately, one minute rest between each set, standing in three positions: standing, standing on non-involved foot, and standing on foot Involved, wobble board exercises with seven countdowns from a random number between 200 and 300. Intervention 3: Control group: This group carries out its daily value activities.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abed Taghavi Asl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>14 Shahed Alley, Suq Town</address>
        <city>Dehdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7573114383</zip>
        <telephone>+98 74 4326 2769</telephone>
        <email>ataghaviasl72@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Sadradin Shojaedin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshvari Educational Sport Complex, South Razan Ave., Mirdamad Blvd, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۵۴۴۷۳۳۱۱۱</zip>
        <telephone>+98 26 3451 2001</telephone>
        <email>shojaeddin@khu.ac.ir</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Active men between 18 and 25 years old.
BMI is between 18 and 25.
History of at least 2 reports of giving way in the last 6 months.
The last injury occurred more than 6 weeks before the start of the study.
Ability to bear weight on the injured limb. (Finally have a slight feeling of discomfort.)
History of at least one significant ankle sprain on one side that has caused pain and decreased function for more than a day.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of vestibular or neuro-musculoskeletal disorders.
History of lower limb surgery.
Lower limb injury for at least 6 months prior to this study.
Use of medications that affect balance, such as betahistine and blood pressure and sedative medications.
Having musculoskeletal abnormalities in the lower extremities such as flat feet, genu varum.
physiotherapy or participating in physical rehabilitation in the past 3 months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.37</hc_code>
      <hc_code>Y93</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other instability, ankle and foot</hc_keyword>
      <hc_keyword>Activity codes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For 5 weeks, three sessions per week, 5 sets, each set 40 seconds, every 10 seconds to rotate alternately, one minute rest between each set, standing in three positions: standing, standing on non-engaged leg, and standing on foot Involved, wobble board exercises</i_keyword>
      <i_keyword>Intervention group: For 5 weeks, three sessions per week, 5 sets, each set 40 seconds, every 10 seconds to rotate alternately, one minute rest between each set, standing in three positions: standing, standing on non-involved foot, and standing on foot Involved, wobble board exercises with seven countdowns from a random number between 200 and 300</i_keyword>
      <i_keyword>Control group: This group carries out its daily value activities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before the intervention and after the last intervention session. Method of measurement: Dynamic balance with Y balance test and static balance with balance error scoring system.</prim_outcome>
      <prim_outcome>Ankle proprioception. Timepoint: Before the intervention and after the last intervention session. Method of measurement: Subjects' ankles are evaluated using an isokinetic device in the reconstruction of two positions of 15 degrees of inversion and a maximum inversion of minus 5 degrees.</prim_outcome>
      <prim_outcome>Some jump landing kinetic parameters. Timepoint: Before the intervention and after the last intervention session. Method of measurement: Ground reaction force information during jump-landing task is recorded using force plate (Kistler, Winterthor, Switzerland, 1000 Hz).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-13</approval_date>
        <contact_name>Kinesiology Research Center</contact_name>
        <contact_address>Keshvari Educational Sport Complex, South Razan Ave., Mirdamad Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
