<?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>IRCT2017071535097N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-19</date_registration>
      <primary_sponsor>University of Social Welfare and Rehabilitation Sciences</primary_sponsor>
      <public_title>The effect of walking with reverse heel shoes on improving knee osteoarthritis symptoms</public_title>
      <acronym></acronym>
      <scientific_title>The effect of walking with reverse heel shoes concomitant with routine physiotherapy program on pain, range of motion, stride length, walking speed and disability in patients with knee osteoartritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26625</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First patient  and as the same manner the rest of  patients who had odd numbers were placed in control group and second patient and the rest of patients with even numbers in intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoartritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Walking with reverse heel shoes in 15 minutes for two times in each session  during 10 session plus routine physiotherapy including continuous ultrasound (1 MHZ frequency and 1 w/cm2) for 6 minutes then conventional TENS (100 HZ frequency and 50 microsecond so that can be sense with hot pack in anterior and posterior of knee for 20 minutes , resistance exercises for quadriceps , hip abductors and calf leg muscles. Intervention 2: Control group: Routine physiotherapy including continuous ultrasound (1 MHZ frequency and 1 w/cm2) for 6 minutes then conventional TENS (100 HZ frequency and 50 microsecond so that can be sense with hot pack in anterior and posterior of knee for 20 minutes , resistance exercises for quadriceps , hip abductors and calf leg muscles.</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>Mohsen Shams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Blind Alley, Daneshjoo Boulevard, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 7739 4525</telephone>
        <email>mo.shams@uswr.ac.ir</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Shams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Blind Alley, Daneshjoo Boulevard, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 7739 4525</telephone>
        <email>mo.shams@uswr.ac.ir</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of patient between 40-65 years old
Knee DJD intensity is 2-3 degree on Kellgren &amp; Lawrence
Symptoms beginning is gradual
Not being occur after trauma or accident or fracture
The most pain intensity that patient suffered in the last week would be at least 30 of 100 on Visual Analog Scale</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Joint injection therapy in recent 3 months
Knee joint ligament injury
Body Mass Index is more than 30 kg/m2
Systemic arthritis
Using cane or crutch or walker</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gonarthrosis [arthrosis of knee]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Walking with reverse heel shoes in 15 minutes for two times in each session  during 10 session plus routine physiotherapy including continuous ultrasound (1 MHZ frequency and 1 w/cm2) for 6 minutes then conventional TENS (100 HZ frequency and 50 microsecond so that can be sense with hot pack in anterior and posterior of knee for 20 minutes , resistance exercises for quadriceps , hip abductors and calf leg muscles</i_keyword>
      <i_keyword>Control group: Routine physiotherapy including continuous ultrasound (1 MHZ frequency and 1 w/cm2) for 6 minutes then conventional TENS (100 HZ frequency and 50 microsecond so that can be sense with hot pack in anterior and posterior of knee for 20 minutes , resistance exercises for quadriceps , hip abductors and calf leg muscles</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: Befor intervention - After end of the intervention - 20 days following end of the intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Rang Of Motion. Timepoint: Befor intervention - After end of  intervention - 20 days following end of the intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Walking speed. Timepoint: Befor intervention - After end of  intervention - 20 days following end of the intervention. Method of measurement: 10 meter walk test.</prim_outcome>
      <prim_outcome>Stride length. Timepoint: Befor intervention - After end of  intervention - 20 days following end of the intervention. Method of measurement: To meter walked 15 stride then division it per 15.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Befor intervention - After end of  intervention - 20 days following end of the intervention. Method of measurement: Knee injury and Osteoartritis Outcome Score.</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>University of Social Welfare and Rehabilitation Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-18</approval_date>
        <contact_name>University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodakyar Blind Alley , Daneshjoo Boulevard , Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
