<?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>IRCT20190225042840N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-18</date_registration>
      <primary_sponsor>Brain Mapping Center of Loghman Hakim Hospital</primary_sponsor>
      <public_title>ambulation of SCI paraplegic patients with LEX mark 3</public_title>
      <acronym></acronym>
      <scientific_title>evaluation of rehabilitation and gait of SCI paraplegic patients using LEX mark 3 device</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>8</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37865</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: In this study, all patients participating in the study received intervention including electrical stimulation of the lower limb and then  variables including distance traveled, walking time, and standing time were evaluated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: paraplegic patients with thoracic spinal cord injury. Condition 2: lumbar spinal cord injury.</hc_freetext>
      <i_freetext>Intervention group: Paraplegic patients using a functional electrical stimulation device for rehabilitation.</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:
This study will publish the data from the study in the article and ensure that no identifiable information is provided by the participants in the study.Also, if written consent is obtained from patients, photos or videos of patients standing and walking without their identity will be released.

When:
The research data will be completed by mid-1399 and will be available 5 months after the results are published in paper.

To whom:
The best target for data from this study are researchers and physicians. Other people associated with paraplegic individuals and patients such as associations and centers of spinal cord injury, disability support centers, rehabilitation centers, and even paraplegics are also able to use The information from this study will be. So information will be available.

Conditions:
Applicants must state their request for information and its cause in a clear and concise manner. When using information at conferences and conferences, the principles of confidentiality must be followed and the source of information, including researchers, if the paper is prepared, The exact address of the article should also be mentioned. Also, if the data is used for other research, make sure to include it in the references section of the article.

Where to obtain:
All applicants who receive information from this research can submit their request for research information to allahyarisam@yahoo.com or call 09370773786 or come to the Brain Mapping Center of Shahid Beheshti University of Medical Sciences and submit their written request.

How to obtain:
The applicant first submits his / her application via email or telephone. Then, his / her application will be reviewed at the Brain Mapping Center of Shahid Beheshti University of Medical Sciences. If agreed, the requested information will be sent to the applicant within a maximum of ten business days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sam Alahyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No24,2nd north shian deadend,lavizan,tehran,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1678675731</zip>
        <telephone>+98 21 2293 8669</telephone>
        <email>allahyarisam@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sam Alahyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No24,2nd north shian deadend,lavizan,tehran,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1678675731</zip>
        <telephone>+98 21 2293 8669</telephone>
        <email>allahyarisam@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>paraplegic patients with loss of sense  in lower extremities.
paraplegic patients with loss of voluntary movements.
normal function of upper extremities.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>autonomic dysreflexia
presence of malignancy in lower extremities at electrode junctions
presence of ulcer in lower extremities at electrode junctions
any kind of deformity in lower extremities,trunk or upper extremities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S24.0XXS</hc_code>
      <hc_code>S34.01XS</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Concussion and edema of thoracic spinal cord, sequela</hc_keyword>
      <hc_keyword>Concussion and edema of lumbar spinal cord, sequela</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Paraplegic patients using a functional electrical stimulation device for rehabilitation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The first variable is the distance traveled by the patient using the device.Its definition includes the displacement performed by patients by lower extremities and with the aid of the device. Timepoint: The time to measure this variable is at the end of each training session. Method of measurement: The distance traveled by patients will be measured and recorded.</prim_outcome>
      <prim_outcome>The second variable in this study is the duration of walking and standing of each patient. Its definition includes amount of time spent by the patient walking and standing during a session. Timepoint: The time to measure this variable is at the end of each training sessions. Method of measurement: Minutes are route of measurement and reporting this variable.</prim_outcome>
      <prim_outcome>The third variable of the study is the number of sessions needed to train patients to use the device. Timepoint: In this study, the number of sessions required for patients after completing their training is evaluated and calculated. The total number of sessions will be calculated when patients have the necessary ability to use the device to get up and walk. Method of measurement: The number of patient training sessions will be recorded in the office and the number of sessions will be calculated based on the days recorded.</prim_outcome>
      <prim_outcome>The ambulation pace of patients is the result of the distance traveled by the duration of walking in each session. Timepoint: At the end of each training session, the distance traveled by the patients is recorded and divided to the duration of travel. Method of measurement: This variable is obtained by dividing the distance traveled by time. The unit of measurement is meters per second.</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>Brain Mapping Center of Loghman Hakim Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-10</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>loghman Hakim hospital, Makhsoos St., South Karegar Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
