<?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>IRCT201206071722N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-18</date_registration>
      <primary_sponsor>Tehran University of edical Sciences</primary_sponsor>
      <public_title>Effect of Robotic-Assisted Locomotor Training and Conventional Gait Training on Movement Pattern of Hip and Knee Joints in Subjects with Chronic Incomplete Spinal Cord Iinjury</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of Effect of Robotic-Assisted Locomotor Training and Conventional Gait Training on Movement Pattern of Hip and Knee Joints in Sagittal Plane in Subjects with Chronic Incomplete Spinal Cord Iinjury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1216</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>Paraplegia and tetraplegia.</hc_freetext>
      <i_freetext>Intervention 1: Subjects in control group were treated by routine physical therapy. Conventional physical therapy consisted of Functional Electrical Stimulation (FES), weight bearing and overgound walking(Harness etal 2008). Intervention 2: Patients in case group were  trained by Lokomat for 30 min.</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>Fateme Ghiasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation faculty, Shahnazari street, Mirdamad sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965141</zip>
        <telephone>+98 212227124</telephone>
        <email>f_ghiasi_p@yahoo.com</email>
        <affiliation>Rehabilitation faculty, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Reza Hadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation faculty, Shahnazari street, Mirdamad Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 212227124</telephone>
        <email>hadianrs@sina.tums.ac.ir; hadian_ras@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences,TUMS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Patients with traumatic motor incomplete SCI with a neurologic lesion level of L1 or higher with at least one year after lesion; No Dependency on ventilator; Not currently enrolled in physical therapy or other training regimens; Male or Female between 16-55 yrs. old ;No clinically significant sign, impairment or disease including: cardiovascular disease, respiratory disease, orthostatic hypotension, bladder and kidney disease, unhealed decubiti, pressure sore or bed sore, fracture and contracture. Decreased level of consciousness for more than 24 hours after trauma; No history of truamatic barin injury, contracture, hetropic ossification, osteoporosis, osteoarthritis; Score of Modefied Ashworth Scale in lower limb was 3 or less; Completing informed consent; Lokomat group were within the physical size of the Lokomat (ie, greater trochanter to lateral epicondyle  35 cm- 47 cm; pelvis width  50 cm, thigh circumference measured 14 cm above the knee axis  57 cm, and body weight  150 kg)&#13;
Exclusion criteria: Any reaso that interfere with the continuation of treatment or withdrawal by patient ;No complete sessions of treatment in the current study</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G82.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>congenital cerebral palsy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Subjects in control group were treated by routine physical therapy. Conventional physical therapy consisted of Functional Electrical Stimulation (FES), weight bearing and overgound walking(Harness etal 2008).</i_keyword>
      <i_keyword>Patients in case group were  trained by Lokomat for 30 min.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spasticity. Timepoint: before and after intervention. Method of measurement: Ashworth Scale.</prim_outcome>
      <prim_outcome>American Spinal Injury Association(ASIA). Timepoint: before and after intervention. Method of measurement: ASIA Form.</prim_outcome>
      <prim_outcome>Function. Timepoint: before and after intervention. Method of measurement: WISCI II, FAM Questionneare.</prim_outcome>
      <prim_outcome>Cadence. Timepoint: before and after intervention. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Speed of walking. Timepoint: before and after intervention. Method of measurement: treadmill.</prim_outcome>
      <prim_outcome>Kinematic gait parameters. Timepoint: before and after intervention. Method of measurement: Lokomat system.</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>Tehran University of edical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-07</approval_date>
        <contact_name>Ethical committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor, Central Building, Qods Street, Keshawarz Blv. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
