<?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>IRCT20190627044039N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-12</date_registration>
      <primary_sponsor>Shahid bahonar university</primary_sponsor>
      <public_title>Comparison of the effect of balance &amp; strength and hopping exercises on the kinematics of lower extremities in patients with functional ankle instability and Ankle-Sprain Copers Detected by Questionnaire (IdFAI)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of 6 weeks of balance &amp; strength and hopping exercises on the kinematics of lower extremities in patients with functional ankle instability and Ankle-Sprain Copers Detected by Questionnaire (IdFAI)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>55</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42386</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is limited in this study. The method of implementing it is classified randomization, which is used to balance the number of random samples assigned within groups. This method is used to ensure sample size equilibrium between groups over time. After determining the block size by the researcher, the number of groups must also be specified. Then the number of people with the special code is put in the envelope. Mail envelopes will be merged and an envelope will be merged and re-merged. The first envelope falls into group 1, the second envelope in group 2, the third envelope in group 3, the fourth envelope in group 4, and the fifth in group 5. To hide the random assignment, the non-transparent wax seal envelope method will be used with a random sequence. After the random sequence based on the sample size, a number of packages will be prepared and each random sequence generated on the card will be recorded and the cards recorded. The envelopes are inserted in sequence in order to maintain a random sequence at the outer surface of the envelope, numbering is done in the same order and pasted into envelopes. At the beginning of the registration, one of the envelopes will be opened based on the participants' entry and the group will be announced.</study_design>
      <phase>N/A</phase>
      <hc_freetext>functional ankle instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Hoping Exercises: These exercises also come from the latest resources available for ankle joint rehabilitation. These exercises will last for 6 weeks and 3 weekly 45 minute sessions. These 45 minutes include 10 minutes warm-up 30 minutes core exercises and 5 minutes cool down. The tools used in this exercise are paper glues to show the direction of movement. Intervention 2: Control group: The group performs its daily activities and sports activities. Intervention 3: Intervention group: Balance strengthening exercises: These are traditional exercises based on previous studies used for ankle sprain rehabilitation. These exercises will last for 6 weeks and 3 weekly 45 minute sessions. These 45 minutes include 10 minutes warm-up 30 minutes core exercises and 5 minutes cool down. The tools used in these exercises include a balance board and free weights and steppes.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The data is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hasan Kordi Ashkezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani</address>
        <city>ashkezar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8941684391</zip>
        <telephone>+98 35 3272 2139</telephone>
        <email>kordi.sport@gmail.com</email>
        <affiliation>Yazd University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hasan Kordi Ashkezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>taleghani</address>
        <city>ashkezar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8941684391</zip>
        <telephone>+98 35 3272 2139</telephone>
        <email>kordi.sport@gmail.com</email>
        <affiliation>Yazd University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>An athlete who exercises regularly at least three times a week.
He has experienced at least one external ankle sprain in the past 12 months, having undergone treatment.
Physiotherapist's confirmation of functional instability of the athlete's ankle
Age range from 16 to 40 years</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having neurological disorders
Having a lower limb injury or ankle sprain last month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of ankle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Hoping Exercises: These exercises also come from the latest resources available for ankle joint rehabilitation. These exercises will last for 6 weeks and 3 weekly 45 minute sessions. These 45 minutes include 10 minutes warm-up 30 minutes core exercises and 5 minutes cool down. The tools used in this exercise are paper glues to show the direction of movement.</i_keyword>
      <i_keyword>Control group: The group performs its daily activities and sports activities</i_keyword>
      <i_keyword>Intervention group: Balance strengthening exercises: These are traditional exercises based on previous studies used for ankle sprain rehabilitation. These exercises will last for 6 weeks and 3 weekly 45 minute sessions. These 45 minutes include 10 minutes warm-up 30 minutes core exercises and 5 minutes cool down. The tools used in these exercises include a balance board and free weights and steppes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kinematic of lower extremity. Timepoint: before of intervention and after six week intervention. Method of measurement: questionnaire and optitrack camera.</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>Shahid bahonar university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-27</approval_date>
        <contact_name>veterinary faculty of shahid bahonar university of kerman</contact_name>
        <contact_address>Veterinary Medicine faculty, shahid bahonar university, emen khomeini highway, kerman kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
