<?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>IRCT2016011726056N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-28</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cross education and trans-cranial magnetic stimulation in stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of contralateral limb cross education and high frequency repetitive trans-cranial magnetic stimulation on functional indices of affected upper limb in subacute stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21700</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hemiplegia.</hc_freetext>
      <i_freetext>Intervention 1: for first group ( control group), routine physiotherapy for affected upper exterimity of hemiplegia is applied in 10 sessions ,3 times a  week.  routine physiotherapy sessions include joints range of motions, gentle stretching of hapertonic muscles, strengthening of muscle weakness, learning of activity daily living and functional electrical stimulation. Intervention 2: For the second group,The subject is seated, both arms are relaxed and unaffected elbow is flexed to a right angle, with the unaffected forearm is in nutral position and  resting on a table.  maximal grip force of unaffected hand is measured by grip dynamometer. Then, subject grasps unaffected hand with 60-70% of maximal voluntary contraction 30 times in each sessions.  Each patient receives 10 treatment sessions (3 times a week) of  cross education technique.in addition,  Routine physiotherapy is performed in each session. Intervention 3: For the third group, HF- rTMS Is applied over the primary motor cortex for the fingers of the&#13;
lesional hemisphere. Each rTMS session consists of 2000 pulses. Site of stimulation on&#13;
the skull is defined as the location where the largest motor evoked potentials of the first dorsal interosseous muscle in the unlesioned upper exterimity are elicited on electromyography. the intensity of stimulation is set at 90% of&#13;
the motor threshold  of the first dorsal interosseous muscle. Frequency of stimulation is 20 Hz and .Each patient receives 10 treatment sessions (3 times a week) of  rTMS.&#13;
Routine physiotherapy is performed after the application of rTMS sessions. Intervention 4: For the fourth group cross education ( similar to second group), HF-rTMS (similar to third group) and physiotherapy is applied in each session.Each patient receives 10 treatment sessions (3 times a week).</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>Farzaneh Moslemi Haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Contact details : 	POBox: 71345-1733, Rehabilitation Sciences Faculty, Abiverdi 1 street, Chamran Blvd., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>moslemif@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Razeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>POBox: 71345-1733, Rehabilitation Sciences Faculty, Abiverdi 1 street, Chamran Blvd., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>razeghm@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:hemiplegic patients aged between30-65 years; hemiplegia after first stroke;having 22-44 scale in Fugle- Meyer Scale ;&#13;
Exclusion criteria:having fracture, dislocation and subluxation in upper exterimity, rheumatoid diseases in upper exterimities; other neurologic diseases; limiting range of motionin upper exterimity; epilepsy; cardiac arythmia; implant in skull; aphasia</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G81.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemiplegia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>for first group ( control group), routine physiotherapy for affected upper exterimity of hemiplegia is applied in 10 sessions ,3 times a  week.  routine physiotherapy sessions include joints range of motions, gentle stretching of hapertonic muscles, strengthening of muscle weakness, learning of activity daily living and functional electrical stimulation.</i_keyword>
      <i_keyword>For the second group,The subject is seated, both arms are relaxed and unaffected elbow is flexed to a right angle, with the unaffected forearm is in nutral position and  resting on a table.  maximal grip force of unaffected hand is measured by grip dynamometer. Then, subject grasps unaffected hand with 60-70% of maximal voluntary contraction 30 times in each sessions.  Each patient receives 10 treatment sessions (3 times a week) of  cross education technique.in addition,  Routine physiotherapy is performed in each session.</i_keyword>
      <i_keyword>For the third group, HF- rTMS Is applied over the primary motor cortex for the fingers of the&#13;
lesional hemisphere. Each rTMS session consists of 2000 pulses. Site of stimulation on&#13;
the skull is defined as the location where the largest motor evoked potentials of the first dorsal interosseous muscle in the unlesioned upper exterimity are elicited on electromyography. the intensity of stimulation is set at 90% of&#13;
the motor threshold  of the first dorsal interosseous muscle. Frequency of stimulation is 20 Hz and .Each patient receives 10 treatment sessions (3 times a week) of  rTMS.&#13;
Routine physiotherapy is performed after the application of rTMS sessions.</i_keyword>
      <i_keyword>For the fourth group cross education ( similar to second group), HF-rTMS (similar to third group) and physiotherapy is applied in each session.Each patient receives 10 treatment sessions (3 times a week).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Grip strength. Timepoint: before and after intervention. Method of measurement: grip dynamometer.</prim_outcome>
      <prim_outcome>Pinch strength. Timepoint: before and after intervention. Method of measurement: Pinch gauge.</prim_outcome>
      <prim_outcome>Dexturity. Timepoint: before and after intervention. Method of measurement: Box and Block Test.</prim_outcome>
      <prim_outcome>Muscle tone. Timepoint: before and after intervention. Method of measurement: Modified Ashworth Scale.</prim_outcome>
      <prim_outcome>Functional movement of hand. Timepoint: before and  after intervention. Method of measurement: Fugle- Meyer Scale.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Blv. Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
