<?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>IRCT20200315046780N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-16</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Ankle Support on walking pattern in people with frequent Ankle Sprain</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of Neoprene Ankle Support with figure 8 Straps on Rearfoot and Ankle Kinematic in people with Chronic Ankle Sprain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46547</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This study investigates the effect of one intervention (how to fasten the Neoprene Ankle Support straps) on ankle kinematics and rearfoot in healthy individuals and then in individuals with chronic ankle sprain. The method of this study is before-afte.4 conditions including no strap and 3 types of straping will be investigated in a randomised order.the same intervention with the same method will be conducted in a group of individuals with chronic ankle sprain to undrestand the common effect of impairment and intervention together.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Ankle Sprain.</hc_freetext>
      <i_freetext>This study investigates the effect of one intervention (how to fasten the Neoprene Ankle Support straps) on ankle kinematics and rearfoot in healthy individuals and then in individuals with chronic ankle sprain. The method of this study is before-afte.4 conditions including no strap and 3 types of straping (using Neoprene Ankle Support with equal force of straps, using Neoprene Ankle Support with Evertor force of straps and using Neoprene Ankle Support with Invertor force of straps) will be investigated in a randomised order.the same intervention with the same method will be conducted in a group of individuals with chronic ankle sprain to undrestand the common effect of impairment and intervention together..</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 Decide to check more and confidentiality of participants' data files</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Ranjbar Sehpole</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>in front of Motamed Clinic, Sartip Cross, Taleghani Ave</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8136835133</zip>
        <telephone>+98 31 3434 0190</telephone>
        <email>inspiration_r11@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Ranjbar Sehpole</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>in front of Motamed Clinic, Sartip Cross, Taleghani Ave</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8136835133</zip>
        <telephone>+98 31 3434 0190</telephone>
        <email>inspiration_r11@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A History of at least one Ankle Sprain in the past three months that has resulted in Pain, Swelling, Stiffness and prevent People from participating in Sports, Recreation or other Activities for at least three weeks
The existence of Mechanical Instability
Frequent ََAnkle Sprain at least 2 times in the last 12 months
Low to medium Ankle Sprain
Chronic Unilateral Ankle Sprain and no injury to the opposite side
There are at least 5 reports of Ankle giving a way and tendency to Ankle giving a way during Exercise.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Initial Ankle Sprain and Ankle giving a way during the last 6 weeks
History of Fracture or Ankle Surgery, Lower Extremity pain not related to Ankle Sprain
Extreme Ankle Sprain
Pain in the lower Limb that is not related to Ankle Sprain
Balance problems, other Orthopedic diseases, Systemic and Neurological diseases such as Diabetes, MS, Stroke and Cerebral Palsy
Recent participation in a Rehabilitation program over the past month
History of using Neoprene Ankle Support over the past month
Over 90% score in Foot and Ankle Disability Index questionnaire</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study investigates the effect of one intervention (how to fasten the Neoprene Ankle Support straps) on ankle kinematics and rearfoot in healthy individuals and then in individuals with chronic ankle sprain. The method of this study is before-afte.4 conditions including no strap and 3 types of straping (using Neoprene Ankle Support with equal force of straps, using Neoprene Ankle Support with Evertor force of straps and using Neoprene Ankle Support with Invertor force of straps) will be investigated in a randomised order.the same intervention with the same method will be conducted in a group of individuals with chronic ankle sprain to undrestand the common effect of impairment and intervention together.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rearfoot and Ankle Kinematic. Timepoint: Measurement of the Ankle and Rearfoot Kinematic at the beginning of the study (without Intervention or without the use of Neoprene Ankle Support) with 7 repetitions and then the Kinematic of Ankle and Rearfoot measured with using the Neoprene Ankle Support. Method of measurement: Using QTM software, inematic data is recorded, then we use Visual-3D software for kinematic analysis and data modeling and then statistical analysis is performed with SPSS software.</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>Vice-Chancellery for Research and Technology of Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-08</approval_date>
        <contact_name>Ethics committee of Esfahan University of Medical Sciences</contact_name>
        <contact_address>Esfahan University of Medical Science, Hezar Jerib St Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
