<?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>IRCT20140219016643N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-26</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Immediate effect of medical shoe on the gait kinetics in children with Flexible Flatfoot</public_title>
      <acronym></acronym>
      <scientific_title>The Immediate effect of medical shoe on the gait kinetics in children with Flexible Flatfoot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70902</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>flexible flat foot.</hc_freetext>
      <i_freetext>Intervention 1: • First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes( with rigid sole, soft sole and regular shoe) for 5 minutes to adapt to it, and then enters the measurement phase. Using the Kistler force plate device, we ask the child to walk on the force plate once in a position with normal shoes. COP and the parameters of vertical ground reaction forces, anterior posterior and internal external forces of ground reaction during walking are measured and checked. Intervention 2: Intervention group: • First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes for 5 minutes to adapt to it, and then enters the measurement step. Using the Kistler force plate device, we ask the child To walk on the force plate with thick sole medical shoes. • COP and parameters of vertical ground reaction forces, anterior posterior and internal external forces of ground reaction during walking are measured and checked. Intervention 3: Intervention group: • First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes for 5 minutes to adapt to it, and then enters the measurement phase. Using the Kistler force plate device, we ask the child to walk on the force plane in the condition of thin-soled medical shoes. • COP and the parameters of the vertical ground reaction forces, anterior, posterior and internal external forces of the ground reaction during walking are measured and checked.</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:
The average data will be reported in the paper extracted from the research

When:
The start of the access period after the publication of the article

To whom:
public

Conditions:
The results of this research

Where to obtain:
contact with : farahmandb1@yahoo.com

How to obtain:
Depending on the conditions of the journal, the results are printed

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behshid Farahmand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahnazari st- Mother Sq- Rehabilitation science faculty Tehran Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 0947</telephone>
        <email>farahmandb1@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behshid Farahmand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahnazari st- Mother Sq- Rehabilitation science faculty Tehran Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11545913487</zip>
        <telephone>+98 21 2222 0947</telephone>
        <email>farahmandb1@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>moderate and  sever flexible flatfoot based onFPi-6
Bilateral flexible flat foot
age 6-10
non fracture and surgery
without systemic disease like CP or rickets
without genuvalgum or genuvarum</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The person's lack of consent to continue cooperation
The feeling of discomfort or fatigue of the person in such a way that she is not able to continue cooperation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q66.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congenital pes planus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>• First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes( with rigid sole, soft sole and regular shoe) for 5 minutes to adapt to it, and then enters the measurement phase. Using the Kistler force plate device, we ask the child to walk on the force plate once in a position with normal shoes. COP and the parameters of vertical ground reaction forces, anterior posterior and internal external forces of ground reaction during walking are measured and checked.</i_keyword>
      <i_keyword>Intervention group: • First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes for 5 minutes to adapt to it, and then enters the measurement step. Using the Kistler force plate device, we ask the child To walk on the force plate with thick sole medical shoes. • COP and parameters of vertical ground reaction forces, anterior posterior and internal external forces of ground reaction during walking are measured and checked.</i_keyword>
      <i_keyword>Intervention group: • First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes for 5 minutes to adapt to it, and then enters the measurement phase. Using the Kistler force plate device, we ask the child to walk on the force plane in the condition of thin-soled medical shoes. • COP and the parameters of the vertical ground reaction forces, anterior, posterior and internal external forces of the ground reaction during walking are measured and checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Earth reaction force: According to Newton's third law, the earth reaction force is the force that the earth exerts on an object in contact with it. When a person is just standing, this force corresponds to the person's weight. When the body is moving, the ground reaction force increases due to acceleration forces. The ground reaction force has three components: fz, fx, and fy. • Vertical ground reaction forces Fz • vGRF is the largest component of the ground reaction force along the path. It is walking that results in forces greater than one body weight at each step. The vGRF curve consists of two peaks: the first peak (in the weight bearing phase) and the second peak (push off phase). This force is to support the body and prevent the body from falling during movement. The vertical ground reaction force represents the magnitude and pattern of vertical mechanical loading on the foot and is commonly used in the diagnosis of abnormal gait. The type of movement, the slope of the ground, the speed of movement, body mass, mass distribution, the material of the shoe, the material of the movement surface, and the mechanics of the foot are effective in the amount of this force. Ground reaction forces in the anterior-posterior direction F The forces of this component of the ground reaction are smaller than It is vertical and is about 25% of body weight. At the beginning of the stationary phase, this force causes the leading foot to brake or slip, and its value is negative in the first 50%, indicating that the person is pushed backwards, and at the end of the stationary phase, it is towards the front, and its value is positive. be And it makes progress forward. Timepoint: immediate. Method of measurement: Using Kistler's Force plate device, we ask the child to walk on the force plate once with normal shoes, once with thick sole medical shoes and another time with thin sole medical shoes. We measure the parameters of vertical forces of ground reaction, anterior, posterior and internal external forces of ground reaction which are recorded in the form of a diagram while walking in three test situations.</prim_outcome>
      <prim_outcome>• The amount of displacement of the center of pressure: • Theoretical definition: the value of displacement of the result point of the earth's reaction force • Applied definition: the number shown by the computer dynamic state device in centimeters related to the X and Y axes. Timepoint: immediate. Method of measurement: Using the Kistler plate force plate device, we ask the child to walk on the force plate once with normal shoes, once with thick sole medical shoes and another time with thin sole medical shoes. We record the number shown by the computerized body dynamics device in centimeters related to the X and Y axes.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-10</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahrake Quds  - between South Flamak and Zarafshan - Simai  Iran - Ministry of Health headquarters Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
