<?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>IRCT2016102430477N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-01</date_registration>
      <primary_sponsor>Vice Chancellor of Research, Shiraz University of Medical Science</primary_sponsor>
      <public_title>Effct of Rehabilitation in Stroke Recovery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of the effect of cross education training of unaffected upper limb on neurophysiological parameters and functional indices of affected upperlimb in sub-acute stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24206</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>stroke.</hc_freetext>
      <i_freetext>Intervention 1: control group: conventional rehabilitation (electrical stimulation of paretic limbs, combined functional patterns of affected upper limb, gentle stretch of hypertone muscle, balance exercise, gait training, and activities of daily living training) 40 min per session, 3 days a week for 4 weeks. Intervention 2: intervention group: conventional rehabilitation (electrical stimulation of paretic limbs, combined functional patterns of affected upper limb, gentle stretch of hypertone muscle, balance exercise, gait training, and activities of daily living training) 40 min per session, 3 days a week for 4 weeks and  cross education training (strength training of wrist extensor muscles of unaffected side,five sets of 6 maximum effort concentric- eccentric wrist extension repetitions and rest is 2 min between sets) 3 days a week for 4 weeks.</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>Nasrin Salehi Dehno</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Street, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14336 - 71348</zip>
        <telephone>+98 71 3235 7282</telephone>
        <email>salehi_na@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Kamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Street, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33669-71947</zip>
        <telephone>+98 71 3626 5108</telephone>
        <email>fahimehkamali@hotmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
First-ever stroke resulting in right or left upper limb paresis and stroke had occurred between 2 weeks and 3 months; CT or MRI documenting a monohemispheric lesion as determined by a neurologist; Age between 18 and 80 years old; Patients with right-hand dominant according to Edingburg handedness scale; Patients with severe motor deficit of wrist extensor (score of 2 or less in strength test scale); Patients with severe to moderate motor impairment of affected upper limb (points less than 45 in items related to upper limb motor function); Not taking anti-spasticity drugs.&#13;
Exclusion criteria:&#13;
Other neurological diseases; Presence of pain, fracture, surgical history and joint dislocation of upper extremity; Contraindications to transcranial magnetic stimulation (TMS) including cardiac pacemaker, metal implants in skulls or eye, past history of seizure ; Presence of dementia, severe cognitive impairment (score of less than 24 points on the mini-mental status examination), aphasia and depression that made the patient uncooperative; Current use of drugs that could affect the excitability of the motor cortex, such as anti-epileptic and psychoactive drugs.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>164</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>stroke, not specified as haemorrhage or infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control group: conventional rehabilitation (electrical stimulation of paretic limbs, combined functional patterns of affected upper limb, gentle stretch of hypertone muscle, balance exercise, gait training, and activities of daily living training) 40 min per session, 3 days a week for 4 weeks</i_keyword>
      <i_keyword>intervention group: conventional rehabilitation (electrical stimulation of paretic limbs, combined functional patterns of affected upper limb, gentle stretch of hypertone muscle, balance exercise, gait training, and activities of daily living training) 40 min per session, 3 days a week for 4 weeks and  cross education training (strength training of wrist extensor muscles of unaffected side,five sets of 6 maximum effort concentric- eccentric wrist extension repetitions and rest is 2 min between sets) 3 days a week for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rest motor threshold. Timepoint: before intervention, after intervention. Method of measurement: TMS device.</prim_outcome>
      <prim_outcome>Active motor threshold. Timepoint: before intervention, after intervention. Method of measurement: TMS device.</prim_outcome>
      <prim_outcome>Recruitment curve. Timepoint: before intervention, after intervention. Method of measurement: TMS device.</prim_outcome>
      <prim_outcome>Cortical silent period. Timepoint: before intervention, after intervention. Method of measurement: TMS device.</prim_outcome>
      <prim_outcome>Ipsilateral silent period. Timepoint: before intervention, after intervention. Method of measurement: TMS device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Measuring performance in activities of daily living. Timepoint: before intervention, after intervention. Method of measurement: Modified Barthel Index.</sec_outcome>
      <sec_outcome>Spasticity. Timepoint: before intervention, after intervention. Method of measurement: modified modified ashworth scale.</sec_outcome>
      <sec_outcome>Wrist extensor muscle strength. Timepoint: before intervention, after intervention. Method of measurement: isokinetic dynamometer biodex device.</sec_outcome>
      <sec_outcome>Assessment of motor function. Timepoint: before intervention, after intervention. Method of measurement: Fugl-Meyer Assessment.</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 of Research, Shiraz University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-17</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Street, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
