<?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>IRCT20220717055484N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-26</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive load on postural control and walking balance in healthy people and patients with Functional Ankle Instability</public_title>
      <acronym></acronym>
      <scientific_title>Attentional demands of postural control while walking in individuals with and without Functional Ankle Instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64854</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Diagnostic, Other design features: People are randomly divided into two groups: healthy and patients with functional ankle instability. Both groups start walking in the same way in two modes: 1) simple and 2) with cognitive tasks randomly for a certain period, Blinding description: Due to the presence of a colleague who collects the data, the study is blinded, and the person who performs the data analysis (researcher) is different from the person who conducts the tests.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Functional Ankle Instability.</hc_freetext>
      <i_freetext>Intervention 1: Control group: group of healthy people with no history of ankle sprain. Intervention 2: Intervention group: Patients with functional ankle instability.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All the above will be published in the article.

When:
After publishing the article.

To whom:
After the article is published, everyone can access it.

Conditions:
Other researchers, as well as therapists in the field of medicine and rehabilitation, can use this study after the publication of the article.

Where to obtain:
After publishing the article, you can find and access the data by searching the Internet.

How to obtain:
After publishing the article, you can find and access the data by searching the Internet.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tina Banakheiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, Imam Hossein Square, Damavand Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 4405 4598</telephone>
        <email>tinabanakheiri@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tina Banakheiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, Imam Hossein Square, Damavand Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 4405 4598</telephone>
        <email>tinabanakheiri@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men in the age range of 18 to 40 years
At least one significant ankle sprain occurred more than 12 months ago and at least two episodes of the ankle giving way or an ankle sprain in the past year
Absence of mechanical instability in the affected ankle by performing the anterior drawer and talar tilt test by the physiotherapist
Absence of injury, pain, and swelling of the ankle during the last 3 months (an injury that makes the person unable to put weight on the affected side and impairs the person's performance)
No physiotherapy treatment from 3 months before entering the study and at the time of evaluation
A score of less than 90% in daily activities and less than 80% in sports using the FAAM questionnaire
No history of any sprain in the ankle for the group of healthy people</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>The presence of uncorrected visual impairment, hearing impairment, dizziness, numbness, paresthesia, fracture, pain, and surgery in the trunk and lower limbs in the 6 months before the study
History of neurological diseases
Use of sleeping and sedative drugs in the 48 hours before the test</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: group of healthy people with no history of ankle sprain</i_keyword>
      <i_keyword>Intervention group: Patients with functional ankle instability</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Linear parameters: maximum anterior-posterior displacement of the center of pressure, maximum medial-lateral displacement of the center of pressure, and displacement speed of the center of pressure. Timepoint: In this study, during a walking assessment session, subjects are asked to take off their shoes and stand at one end of the approximately 8-meter space of the laboratory, maintaining their usual posture with their hands by their sides. With the examiner's order, at their self-selected speed, they start walking during two stages with and without cognitive tasks for approximately 120 seconds (equivalent to 10 times crossing the force plate) so that only the desired leg is on each time the force plate. Method of measurement: Bertec force plate.</prim_outcome>
      <prim_outcome>Non-linear parameters: percentage of repeatability, determination, irregularity, and stability of the center of pressure in anterior-posterior and medial-lateral directions. Timepoint: In this study, during a walking assessment session, subjects are asked to take off their shoes and stand at one end of the approximately 8-meter space of the laboratory, maintaining their usual posture with their hands by their sides. With the examiner's order, at their self-selected speed, they start walking during two stages with and without cognitive tasks for approximately 120 seconds (equivalent to 10 times crossing the force plate) so that only the desired leg is on each time the force plate. Method of measurement: Bertec force plate.</prim_outcome>
      <prim_outcome>Ankle, knee, and hip kinematics in a walking cycle in sagittal, frontal, and horizontal planes. Timepoint: In this study, during a walking assessment session, subjects are asked to take off their shoes and stand at one end of the approximately 8-meter space of the laboratory, maintaining their usual posture with their hands by their sides. With the examiner's order, at their self-selected speed, they start walking during two stages with and without cognitive tasks for approximately 120 seconds (equivalent to 10 times crossing the force plate) so that only the desired leg is on each time the force plate. Method of measurement: Vicon Motion Capture System.</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 Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-19</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Rehabilitation Faculty, Damavand St., in front of Bo Ali Hospital, Tehran City, Tehran Province Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
