<?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>IRCT20170114031942N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-22</date_registration>
      <primary_sponsor>Shahroud University of Technology</primary_sponsor>
      <public_title>Effect of foot orthoses for older adults with pronated foot</public_title>
      <acronym></acronym>
      <scientific_title>The effects of foot orthoses on balance, postural control and dynamic plantar pressure distribution in older adults with pronated foot-A randomized clinical control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30293</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants are firstly enrolled by one of the research colleagues. An independent assessor, blinded person who has no further involvement in the study creates a random allocation sequence using a computer Software prior to the initiation of the study that use to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 8) are applied to ensure an equal number of participants in each group. Group allocation are concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes are opened after enrolled participants complete all baseline assessments.</study_design>
      <phase>3</phase>
      <hc_freetext>Older adult health.</hc_freetext>
      <i_freetext>Intervention 1: Soft insole group: This group receives a soft insole with Shore A below 20 made of polyester and polyurethane sponge. Intervention 2: Textured insole group: This group receives textured insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA). Intervention 3: Standard insole group: This group receives standard insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA). Intervention 4: Hard insole group: This group receives hard insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA).</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aynollah Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran avenue, Shahroud, Semnan Province</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>ay.naderi@shahroodut.ac.ir</email>
        <affiliation>Shahrood University of Technology</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aynollah Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Avenue,  Shahroud, Semnan Province</address>
        <city>shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>Ay.naderi@yahoo.com</email>
        <affiliation>Shahrood University of Technology</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 65 years old
Confirmation of falling risk by falling screening algorithm
Pronated foot confirmation by foot posture index
Independent living in the community
Ability to walk without any help (for example, without a cane or walker)
Medical certificate to participate in the study</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Institutional older adults (nursing home and hospitalized)
A history of depression, anxiety, or other mental disorders confirmed by GDS-15
Presence of neurological or musculoskeletal problems (such as a history of cardiovascular disease, Parkinson's disease, lower extremity surgery, significant orthopedic disorders or acute illness)
Lower extremity prosthetics
Peripheral neuropathy or diabetes
Dementia confirmed by MMSE
Vision problem despite the glasses correction
Previous use of foot orthosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Soft insole group: This group receives a soft insole with Shore A below 20 made of polyester and polyurethane sponge.</i_keyword>
      <i_keyword>Textured insole group: This group receives textured insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA).</i_keyword>
      <i_keyword>Standard insole group: This group receives standard insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA).</i_keyword>
      <i_keyword>Hard insole group: This group receives hard insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of falling. Timepoint: The fear of falling is measured before, immediately and 16 weeks after intervention. Method of measurement: Fall Efficacy Scale International.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Dynamic balance is measured before, immediately and 16 weeks after intervention. Method of measurement: Dynamic gait index.</prim_outcome>
      <prim_outcome>Static balance. Timepoint: Static balance is measured before, immediately and 16 weeks after intervention. Method of measurement: Frailty and Injuries: Cooperative Studies of Intervention Techniques–4.</prim_outcome>
      <prim_outcome>Postural control. Timepoint: Posture control is measured before, immediately and 16 weeks after intervention. Method of measurement: Footscan pressure plat.</prim_outcome>
      <prim_outcome>Dynamic foot pressure distribution patterns. Timepoint: Dynamic foot pressure distribution patterns is measured before, immediately and 16 weeks after intervention. Method of measurement: Footscan pressure plat.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comfort of the orthoses. Timepoint: The comfort of the orthoses is measured immediately after the intervention and 1 week after the intervention. Method of measurement: Comfort Index of Orthotic.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahroud University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahroud University of Technology</source_name>
      <source_name>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-07</approval_date>
        <contact_name>Ethics committee of shahroud university of medical sciences</contact_name>
        <contact_address>Seventh Tir Square, Shahroud shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
