<?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>IRCT2016060628310N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-14</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lateral wedge insole on initiation of walking in Arthrosis of the knee joint</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Lateral Wedge Insole on Gait Initiation in Osteoarthritis of the Tibiofemoral Knee Joint</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22991</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Lateral wedge insole which is put under shoes inner sole. At baseline, participants wear their shoes and lateral wedge insoles for 20 minutes for adaptation. The patients in knee osteoarthritis group wear the lateral wedge insoles in their own shoes for 5 to 10 hours in a day for one month and then will be evaluated for the second time as follow-up. Intervention 2: Participant's shoes. Intervention 3: Barefoot.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Ali Sanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Madadkaran Ave., Shahnazari St., Madar Sq., Mirdamad Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>sanjarima@alum.sharif.edu</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Ali Sanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Madadkaran Ave., Shahnazari St., Madar Sq., Mirdamad Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>sanjarima@alum.sharif.edu</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Osteoarthritis of the medical compartemnt of the tibiofemoral joint based on the American College of Rheumatology (ACR) criteria; pain more than 30 mm based on the Visual Analogue Scale (VAS); grade I and II of osteoarthritis based on the Kellgrene and Lawrence System (K&amp;L)&#13;
Exclusion Criteria: Isolated osteoarthritis of the patellofemoral joint; grade III and IV osteoarthritis; knee surgery; progressive depression syndrome; massage therapy; physical therapy; knee injection in the last month before participation in the study; change in analgesic medication in the last previous 24 hours; knee ligament injuries; knee alignment reconstruction; age younger then 35 years old or older than 65 years old; BMI more than 30 kg/m2; foot problems which prohibited use of lateral wedge insole, including, hallux valgus, foot pronation, flat foot, etc; visual and hearing problems</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary gonarthrosis, bilateral</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Lateral wedge insole which is put under shoes inner sole. At baseline, participants wear their shoes and lateral wedge insoles for 20 minutes for adaptation. The patients in knee osteoarthritis group wear the lateral wedge insoles in their own shoes for 5 to 10 hours in a day for one month and then will be evaluated for the second time as follow-up.</i_keyword>
      <i_keyword>Participant's shoes</i_keyword>
      <i_keyword>Barefoot</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of Anticipatory postural adjustment. Timepoint: pre and 1 month after the intervention. Method of measurement: based on ms by single force plate.</prim_outcome>
      <prim_outcome>Duration of monopedal phase. Timepoint: pre and 1 month after the intervention. Method of measurement: based on ms by single force plate.</prim_outcome>
      <prim_outcome>Duration of bipedal phase. Timepoint: pre and 1 month after the intervention. Method of measurement: based on ms by single force plate.</prim_outcome>
      <prim_outcome>Duration of APA1. Timepoint: pre and 1 month after the intervention. Method of measurement: based on ms by single force plate.</prim_outcome>
      <prim_outcome>Duration of APA2. Timepoint: pre and 1 month after the intervention. Method of measurement: based on ms by single force plate.</prim_outcome>
      <prim_outcome>Duration of LOC. Timepoint: pre and 1 month after the intervention. Method of measurement: based on ms by single force plate.</prim_outcome>
      <prim_outcome>Velocity of COP  trajectory in APA1. Timepoint: pre and 1 month after the intervention. Method of measurement: Based on m/s by single force plate.</prim_outcome>
      <prim_outcome>Velocity of COP trajectory in APA2. Timepoint: pre and 1 month after the intervention. Method of measurement: Based on m/s by single force plate.</prim_outcome>
      <prim_outcome>Velocity of COP trajectory in LOC. Timepoint: pre and 1 month after the intervention. Method of measurement: Based on m/s by single force plate.</prim_outcome>
      <prim_outcome>Length of COP trajectory in APA1. Timepoint: pre and 1 month after the intervention. Method of measurement: based on m by single force plate.</prim_outcome>
      <prim_outcome>Length of COP trajectory in APA2. Timepoint: pre and 1 month after the intervention. Method of measurement: based on m by single force plate.</prim_outcome>
      <prim_outcome>Length of COP trajectory in LOC. Timepoint: pre and 1 month after the intervention. Method of measurement: based on m by single force plate.</prim_outcome>
      <prim_outcome>Total Duration of gait initiation. Timepoint: pre and 1 month after the intervention. Method of measurement: based on ms by single force plate.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Integral of anterior-posterior component of GRF in APA. Timepoint: Pre and 1 month after intervention. Method of measurement: Based on N/s by a single force plate.</sec_outcome>
      <sec_outcome>Integral of anterior-posterior component of GRF in monopedal phase. Timepoint: Pre and 1 month after intervention. Method of measurement: Based on N/s by a single force plate.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-13</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>School of Rehabilitation Sciences, Madadkaran Ave., Shahnazari St., Madar Sq., Mirdamad Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
