<?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>IRCT20221215056826N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-28</date_registration>
      <primary_sponsor>Bu Ali Sina University</primary_sponsor>
      <public_title>The Effect  of Short Foot Exercise and Three- Dimensional Ankle Exercises in People with Flat Foot</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of a Combination of Short Foot Exercise and Three- Dimensional Ankle Exercises on Blance, Proprioception and Foot Pressure Variables in People with Flat Foot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67456</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method. The randomization of subjects is done in two stages. First, each of the subjects chooses a number between 1-30 using a lottery, then using the Random number generator software, fifteen random numbers are selected between the numbers 1-30, and according to the generated numbers and the selected numbers, the subjects are divided into two groups, Blinding description: These people will be unaware of the purpose of the research, the allocation of study groups and the reason for their presence in the laboratory. And they only evaluate the variables and record their observations. The blinding of the participants will be done in such a way that each group will do their own exercises and in order to achieve the blinding, the members of the two groups will be present in the hall to receive the exercises on two different days.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Flat Foot.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group one: short foot exercises, exercises for 8 weeks and 3 sessions of 1 hour per week. Equipment such as foam roller, balance board, elastic band, small glass stones will be used. The training protocol includes plantar fasciitis release, short foot exercises, strength, balance, and proprioceptive exercises. Intervention 2: Intervention group two: the combination of short foot and three- dimensional ankle exercises, the exercises will be for 8 weeks and 3 sessions of 1 hour each week. Equipment such as foam roller, balance board, elastic band, small glass stones will be used. the training protocol includes plantar fasciitis release, peroneal release, short foot and three-dimensional exercises, strength, balance, and proprioception.</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 No More Information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasaman Ghadiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3869565178</zip>
        <telephone>+98 81 3838 1423</telephone>
        <email>y.ghadiri@phe.basu.ac.ir</email>
        <affiliation>Bo Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasaman Ghadiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3869565178</zip>
        <telephone>+98 81 3838 1423</telephone>
        <email>y.ghadiri@phe.basu.ac.ir</email>
        <affiliation>Bo Ali Sina University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 25 years old
Not having history of injury or surgery of the lower limbs
The indicator of navicular Bone drop  be more than 10 mm</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence or creation of pain during the study
And not continuously attending the exercises(absence in the two consecutive sessions or absene in three sessions during the period)
The indicator of navicular Bone drop  be less than 10 mm</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M21.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>M21.4</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 one: short foot exercises, exercises for 8 weeks and 3 sessions of 1 hour per week. Equipment such as foam roller, balance board, elastic band, small glass stones will be used. The training protocol includes plantar fasciitis release, short foot exercises, strength, balance, and proprioceptive exercises.</i_keyword>
      <i_keyword>Intervention group two: the combination of short foot and three- dimensional ankle exercises, the exercises will be for 8 weeks and 3 sessions of 1 hour each week. Equipment such as foam roller, balance board, elastic band, small glass stones will be used. the training protocol includes plantar fasciitis release, peroneal release, short foot and three-dimensional exercises, strength, balance, and proprioception.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Navicular drop, Y balance, proprioception, strength, function, plantar pressure distribution, postural fluctuations, earth reaction force. Timepoint: Before the intervention begins, one day after the end of the intervention. Method of measurement: Brody's method, Y balance device, inclinometer, hand dynamometer, tape measure, foot scan machine.</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>Bu Ali Sina University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-08</approval_date>
        <contact_name>Ethics committee of Bu Ali Sina University</contact_name>
        <contact_address>Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
