<?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>IRCT20190718044261N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-11</date_registration>
      <primary_sponsor>Fund for the Protection of Researchers and Technologists of the Country</primary_sponsor>
      <public_title>Effect of foot insoles and exercise program on subjects with Leg Length Discrepancy  (LLD)</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Two Types of Shoe Insole and Exercise Program on the Dynamics of Lower Extremities Joints in the Disabled with Leg Limb Length Discrepancy during Stance Phase of Walking</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40995</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this method, all participants in the study were assigned a number, and then they were selected using the lottery for each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Leg Limb Length Discrepancy.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: The intervention in this group involves the use of internal insole for Shortness of leg compensation for twelve weeks. The height of the insole in the heel area is equal to the length difference of two legs and does not have a high in the toe area and made of a semi-rigid material. Intervention 2: Second Intervention group: The intervention in this group involves the use of external insole for shortness of leg compensation for twelve weeks. The height of the insole in the heel to toe area is equal to the length difference of two legs and made of a semi-rigid material. Intervention 3: Third intervention group: The intervention in this group involves the use of exercise for twelve weeks. In subjects with short leg limbs due to lateral pelvic tilt, weakness hip abductors, shortness of iliopsoas muscle, muscle weakness lumbar muscles and the shorten of Plantar flexor muscles in short leg, exercise program with an emphasis on weakened muscle strength and stretch the muscles shortened.</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 Data will only be presented in general and in the results of the report of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansour Eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Ave, University of Mazandaran, Faculty of Physical Education and Sport Sciences</address>
        <city>Babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741613534</zip>
        <telephone>+98 11 3530 2210</telephone>
        <email>fr.habibi@yahoo.com</email>
        <affiliation>The University of mazandaran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansour Eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Ave, University of Mazandaran, Faculty of Physical Education and Sport Sciences</address>
        <city>Babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741613534</zip>
        <telephone>+98 11 3530 2210</telephone>
        <email>fr.habibi@yahoo.com</email>
        <affiliation>The University of Mazandaran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The difference in length of the lower limb is between one to two and a half centimeters
Full ability to walk
Age range between 45 and 65 years
No balance problems</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of lower limb rehab program six months before the test
Having a history of using the therapeutic shoe insoles six months before the test
Having a history of lower limb joints fracture or surgery six months before the test
Systemic diseases such as rheumatism and diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M21.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unequal limb length (acquired)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: The intervention in this group involves the use of internal insole for Shortness of leg compensation for twelve weeks. The height of the insole in the heel area is equal to the length difference of two legs and does not have a high in the toe area and made of a semi-rigid material.</i_keyword>
      <i_keyword>Second Intervention group: The intervention in this group involves the use of external insole for shortness of leg compensation for twelve weeks. The height of the insole in the heel to toe area is equal to the length difference of two legs and made of a semi-rigid material.</i_keyword>
      <i_keyword>Third intervention group: The intervention in this group involves the use of exercise for twelve weeks. In subjects with short leg limbs due to lateral pelvic tilt, weakness hip abductors, shortness of iliopsoas muscle, muscle weakness lumbar muscles and the shorten of Plantar flexor muscles in short leg, exercise program with an emphasis on weakened muscle strength and stretch the muscles shortened.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamics of Lower Extremities Joints. Timepoint: At the beginning of the study (before the intervention) and three months after the intervention. Method of measurement: General Health Questionnaire of Subjects, meter, and Scale to measure anthropocentric characteristics, Force plate, Camera and Marker to Record Motion and Calculate Dynamics of Lower Extremities Joints.</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>Fund for the Protection of Researchers and Technologists of the Country</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-06</approval_date>
        <contact_name>Ethics committee of University of Mazandaran</contact_name>
        <contact_address>Shahid Beheshti Ave, University of Mazandaran, Faculty of Physical Education and Sport Sciences Babolsar Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
