<?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>IRCT20220723055526N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-23</date_registration>
      <primary_sponsor>kharazmi University</primary_sponsor>
      <public_title>The effect of adding proprioception exercises to corrective exercises on foot posture, ankle’s proprioception and balance in girls with flat foot and hallux valgus</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adding proprioception exercises to corrective exercises on foot posture, ankle’s proprioception and balance on 9- 12 years in girls with flat foot and hallux valgus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64948</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly divided into three groups by hidden sealed envelope randomization method. In such a way that an equal number of types of interventions are written on sheets of the same size and the sheet is folded in such a way that the type of interventions is not clear. If the patient is selected for the study, the parents randomly take a sheet from the envelope that shows the type of interventions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Flexible flat foot. Condition 2: Hallux valgus.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: People in this group do corrective exercises for 6 weeks, 3 sessions per week and 1 hour in each session, for a total of 18 sessions.These short foot exercises will be given from the unladen position to the loaded standing positions. Intervention 2: The second intervention group: People in this group will do corrective exercises along with proprioception exercises for 6 weeks, 3 sessions per week and each session for an hour, in total 18 sessions, in such a way that these exercises will be performed on a stable surface at first and on an unstable surface in the advanced stages. Intervention 3: Control group: The control group will not do any exercises for 6 weeks and will only participate in the pre-test and post-test.</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:
Only data related to demographics and outcomes are shared.

When:
After printing the article/Article extracted from the study

To whom:
The data can be displayed and shared by the Iran Clinical Trial Registration Center, journals, and academic individuals/researchers who are conducting research and scientific activities in this field upon reasonable request.

Conditions:
Data analysis and the use of documents can only be done under the condition that their results are mentioned in systematic review articles conducted by academic researchers and authors. The necessary conditions for sending data and documents include 1. Sending an email to one of the researchers of the study 2. A brief and logical explanation regarding the use of data or documents. 3. Ensuring the registration of the protocol of systematic review studies that have requested access to data or documents.

Community Verified icon

Where to obtain:
By requesting the study researchers
ZahraDarabi darabida4@gmail.com
MaliheHadadnezhad m.hadadnezhad@yahoo.com
Mehdi Khaleghi Mehdikhaleghi60@yahoo.com

How to obtain:
The applicant can request details using the message sent by email within 7 to 10 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe Hadadnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kharazmi University, University Square,Beheshti Street,Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197937551</zip>
        <telephone>+98 26 3457 9600</telephone>
        <email>m.hadadnezhad@yahoo.com</email>
        <affiliation>kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Darabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.1,7th East Alley, Hanrestan Street,Moshirieh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1855673553</zip>
        <telephone>+98 21 3346 1763</telephone>
        <email>darabida4@gmail.com</email>
        <affiliation>kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Girls 9-12 years old
Has flexible flat foot and  hallux valgus
Normal body mass index</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lower extremity pain
Over weight or obesity
Non-participation of the subject in three consecutive sessions
Causing pain during the research process
Orthopedic injury in the lower limb such as fracture,ankle sprain,tendon rupture,...No foot surgery,systemic disease that effects the lower limb or the pasture of the foot such as cerebral palsy,rickets</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M21.4</hc_code>
      <hc_code>M20.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Flat foot [pes planus] (acquired)</hc_keyword>
      <hc_keyword>Hallux valgus (acquired)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: People in this group do corrective exercises for 6 weeks, 3 sessions per week and 1 hour in each session, for a total of 18 sessions.These short foot exercises will be given from the unladen position to the loaded standing positions.</i_keyword>
      <i_keyword>The second intervention group: People in this group will do corrective exercises along with proprioception exercises for 6 weeks, 3 sessions per week and each session for an hour, in total 18 sessions, in such a way that these exercises will be performed on a stable surface at first and on an unstable surface in the advanced stages.</i_keyword>
      <i_keyword>Control group: The control group will not do any exercises for 6 weeks and will only participate in the pre-test and post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Foot posture. Timepoint: Before intervention and after 6 weeks of intervention. Method of measurement: It is evaluated by the foot posture index.</prim_outcome>
      <prim_outcome>Ankle proprioception. Timepoint: Before intervention and after 6 weeks of intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Balance. Timepoint: Before intervention and after 6 weeks of intervention. Method of measurement: To evaluate the static balance of the bass stick test and the dynamic balance of the modified star or Y test.</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>This study was conducted by researchers and no institutional funding was received</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-20</approval_date>
        <contact_name>Research Institute of Physical Education and Sports Sciences</contact_name>
        <contact_address>N3,Fifth Alley,Mir Emad Street,Ostad Motahari Street,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
