<?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>IRCT2015120116810N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-05</date_registration>
      <primary_sponsor>Vice chancellor for research of Iran University Of Medical Science</primary_sponsor>
      <public_title>Clinical trial of comparing the immediate effect of both conventional and neoprene modified polypropylene ankle foot orthosis on kinematic parameters of gait in people with foot drop syndrome</public_title>
      <acronym>Ankle Foot Orthosis(AFO)</acronym>
      <scientific_title>Clinical trial of Comparing the immediate effect of both conventional and neoprene modified polypropylene  ankle foot orthosis on kinematic parameters of gait in people with foot drop syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15605</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>DROP FOOT.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: drop foot people will walk while wearing modified neoprane orthose in their shoes on kistler force plate to predict the components of the kinetic and kinematic gait . The test process will be explained to the patient and they have to walk with both orthoses for 10 min . After being situated in the corresponding calibration the markers will be placed on bony landmarks and the person starts to walk. In order to detect the markers, the subject wore black trousers, nightwear and light reflective markers will be placed on the fifth metatarsal head, internal and external ankle, tubrasity of calcaneus, medial and latral condyle of femur for both feet. Even the study of the digital camera in the direction of movement is marked and moves will be recorded. The best example of the 3 modes will be selected. The data from these tests will be compared first together and then to the normal foot. Intervention 2: Intervention Group 2:The Test Will Be Taken While They'll Be Wearing Solid AFO With Their Shoes. Intervention 3: Intervention Group 3: The Test Will Be Taken Barefoot.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hassan Saeedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Rehabilitation Sciences, Maddadkaran Alley, Shahnazari Street, Mohseni Square, Mirdamad BLVD. , Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>Www.hassan_saeedi2@yahoo.co.uk</email>
        <affiliation>Iran University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The main inclusion criteria were: participants, with a score of 0 or 1 ankle dorsiflexors which cause their foot to be dragged in swing phase, one-sided weaknessof ankle dorsiflexor muscles, flaccid paralysis of the lower extremities following traumatic nerve injury, aged 25 to 50 years, the ability to walk without assistive devices for a period of 2 min. The exclusion criteria were: any painfull pain in the body, existing an open wound in the areas covered by the orthosis, obvious deformity in the lower extremities, disinclination to do more tests.</inclusion_criteria>
      <agemin>90 years</agemin>
      <agemax>66 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M21.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>(Wrist or foot drop (acquired</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: drop foot people will walk while wearing modified neoprane orthose in their shoes on kistler force plate to predict the components of the kinetic and kinematic gait . The test process will be explained to the patient and they have to walk with both orthoses for 10 min . After being situated in the corresponding calibration the markers will be placed on bony landmarks and the person starts to walk. In order to detect the markers, the subject wore black trousers, nightwear and light reflective markers will be placed on the fifth metatarsal head, internal and external ankle, tubrasity of calcaneus, medial and latral condyle of femur for both feet. Even the study of the digital camera in the direction of movement is marked and moves will be recorded. The best example of the 3 modes will be selected. The data from these tests will be compared first together and then to the normal foot.</i_keyword>
      <i_keyword>Intervention Group 2:The Test Will Be Taken While They'll Be Wearing Solid AFO With Their Shoes.</i_keyword>
      <i_keyword>Intervention Group 3: The Test Will Be Taken Barefoot</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ankle  joint angle. Timepoint: Immediate effect. Method of measurement: Using Kistler force plate and motion analyzer system in degrees.</prim_outcome>
      <prim_outcome>Knee joint angle. Timepoint: Immediate effect. Method of measurement: Using Kistler force plate and motion analyzer system in degrees.</prim_outcome>
      <prim_outcome>Hip joint angle. Timepoint: Immediate effect. Method of measurement: Using Kistler force plate and motion analyzer system in degrees.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Step length. Timepoint: Immediate effect. Method of measurement: Using Kistler force plate in centimeters.</sec_outcome>
      <sec_outcome>Stance during. Timepoint: Immediate effect. Method of measurement: Using Kistler force plate in second.</sec_outcome>
      <sec_outcome>Swing during. Timepoint: Immediate effect. Method of measurement: Using Kistler force plate in second.</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>Vice chancellor for research of Iran University Of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-17</approval_date>
        <contact_name>Ethics committee of iran university of medical science</contact_name>
        <contact_address>Iran university of medical science, Between Sheikh Fazlolah and Chamran Intersection, West Hemmat Highway, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
