<?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>IRCT20150721023277N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-25</date_registration>
      <primary_sponsor>Vice chancellor for research, Iran University of Medical Sciences</primary_sponsor>
      <public_title>effectiveness of Mirror Visual Feedback on sensory relearning outcomes</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial effectiveness of  Mirror Visual feedback on sensory relearning outcomes in patients following Median/Ulnar nerve repair in the upper limbs.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19878</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed Envelope.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Injury of median nerve at wrist of upper extrimity. Condition 2: Injury of ulnar nerve at wrist of upper extrimity.</hc_freetext>
      <i_freetext>Intervention 1: Treatment group: A therapist will be performed a traditional rehabilitation program of 40 minutes, three days per week, for eight weeks. In addition to the traditional rehabilitation program, the treatment group also will  receive mirror therapy sessions 15 minutes per day, five days per week, for eight weeks; three of the mirror therapy sessions are done in a clinic under the supervision by a therapist every week, and the other two sessions will perform by the patients themselves at home using a mirror therapy box with the help of a booklet with instructions. The mirror box contain a 35×45cm mirror set at an 80-degree angle that will construct by the researchers and will distribute among the patients. During their mirror therapy sessions, the patients sit in front of a table that had a mirror box placed at its center and hold their intact hand in front and their injured hand at the back of the mirror with an equal distance from the mirror. The mirror therapy sessions consist of three stages. Stage one involves   performing of movements such as pronation, supination, opposition, etc. for five minutes. Stage two include the patient touching objects with various degrees of coarseness in front of the mirror for five minutes. Stage three involve the performance of activities with the intact hand in front of the mirror; in this stage, the patient will be asked to perform actions such as wiping the table with a cloth, grabbing a book, plate, cell phone, pen, spoon, glass and coin or keys with the intact hand and focus on the image of the intact hand in the mirror throughout the entire activity. Intervention 2: control group: traditional rehabilitation program of 40 minutes, three days per week, for eight weeks, which included rehabilitation techniques such as proprioceptive neuromuscular facilitation, individual blocking exercise, gliding exercise, sensory precaution training, the use of different splints, functional activities and daily life activities.</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>Dr Laleh Lajevardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Nezam Street, Shahid Shah Nazari Street, Mother Square, Mirdamad Boulevard, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>rehab@iums.ac.ir</zip>
        <telephone>+98 212222205</telephone>
        <email>www.laleh23275@yahoo.com</email>
        <affiliation>Faculty of Rehabilitation Sciences, Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr laleh Lajevardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Nezam Street, Shahid Shah Nazari Street, Mother Square, Mirdamad Boulevard, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>154591348</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>rehab@iums.ac.ir</email>
        <affiliation>Faculty of Rehabilitation, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having median or ulnar nerve surgery or both
age 18 to 60 years
a minimum score of 21 in the Mini-Mental State Examination
Four to six weeks interval after surgery (i.e. epineural repair)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diabetes or other peripheral neuropathy
The presence of other orthopedic or neurological damage other than tendon and arterial injury</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.1</hc_code>
      <hc_code>G56.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>other lesions of median nerve</hc_keyword>
      <hc_keyword>lesions of ulnar nerve</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatment group: A therapist will be performed a traditional rehabilitation program of 40 minutes, three days per week, for eight weeks. In addition to the traditional rehabilitation program, the treatment group also will  receive mirror therapy sessions 15 minutes per day, five days per week, for eight weeks; three of the mirror therapy sessions are done in a clinic under the supervision by a therapist every week, and the other two sessions will perform by the patients themselves at home using a mirror therapy box with the help of a booklet with instructions. The mirror box contain a 35×45cm mirror set at an 80-degree angle that will construct by the researchers and will distribute among the patients. During their mirror therapy sessions, the patients sit in front of a table that had a mirror box placed at its center and hold their intact hand in front and their injured hand at the back of the mirror with an equal distance from the mirror. The mirror therapy sessions consist of three stages. Stage one involves   performing of movements such as pronation, supination, opposition, etc. for five minutes. Stage two include the patient touching objects with various degrees of coarseness in front of the mirror for five minutes. Stage three involve the performance of activities with the intact hand in front of the mirror; in this stage, the patient will be asked to perform actions such as wiping the table with a cloth, grabbing a book, plate, cell phone, pen, spoon, glass and coin or keys with the intact hand and focus on the image of the intact hand in the mirror throughout the entire activity</i_keyword>
      <i_keyword>control group: traditional rehabilitation program of 40 minutes, three days per week, for eight weeks, which included rehabilitation techniques such as proprioceptive neuromuscular facilitation, individual blocking exercise, gliding exercise, sensory precaution training, the use of different splints, functional activities and daily life activities</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The threshold of cutaneous touch/pressure. Timepoint: before the intervention and  After the end of the intervention ( two months). Method of measurement: pocket version of Semmes Weinstein Monofilaments (SWMs).</prim_outcome>
      <prim_outcome>Two points discrimination. Timepoint: before the intervention and  After the end of the intervention ( two months). Method of measurement: ( two points discrimination with using a caliper.</prim_outcome>
      <prim_outcome>Tactile gnosis. Timepoint: before the intervention and  After the end of the intervention ( two months). Method of measurement: Stereognosis.</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>Vice chancellor for research, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-14</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Between the intersection of Sheikh Fazlollah Noori and Shahid Chamran, Shahid Hemmat Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
