<?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>IRCT20180526039856N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-10</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>"The mirror therapy and modified constraint-induced movement therapy on  treatment of upper limb stroke patients"</public_title>
      <acronym></acronym>
      <scientific_title>"Comparison of the effect of mirror therapy and modified constraint-induced movement therapy on upper extremity motor function in stroke patients"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31578</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomized with use of random number table, Blinding description: Participants do not inform about interventions present to each other. Assessor varies with the person who intervenes.</study_design>
      <phase>3</phase>
      <hc_freetext>stroke patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: intervention performs 1 hour per day, five days per week, for a total of four weeks. The intervention sessions include performing tasks with upper limb. In addition to occupational therapy sessions the participants in this group will be asked to wear mitts and do functional tasks. Intervention 2: Intervention group 2: intervention performs 1 hour per day, five days per week, for a total of four weeks. After adjusting the mirror, the image reflection of non-affected upper limb will be used in the mirror so that patient is placed in a sitting position and mirror is placed in front of the non-affected upper limb  and patient focuses on the image inside the mirror while practicing. Intervention 3: Control group: common occupational therapy upper limb interventions that include Bobath, Rood and PNF Techniques will perform for 1 hour  per day, five days per week, for a total of four 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Statistical outcomes include MD, SD

When:
"From article acceptation"

To whom:
"Practitioners and students"

Conditions:
"Use of data with permission"

Where to obtain:
Dr Nazila Akbarfahimi, Assistant professor of University of Social Welfare and Rehabilitation Sciences
Address: Kodakyar Ave, Daneshjo Blvd, Evin
Email: na.akbarfahimi@uswr.ac.ir
Zip Code: 1985713834
Tel: 00982122180063

How to obtain:
Email to: na.akbarfahimi@uswr.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0037</telephone>
        <email>sh.abedi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazila Akbarfahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0063</telephone>
        <email>na.akbarfahimi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion is voluntary (completed consent form)
Age range 75-18 years
Ischemic or hemorrhage stroke diagnosed by neurologist
Stage 4, 5 and 6 Brunnstrom in proximal and distal of upper extremities
Sufficient cognitive ability to understand and execute verbal and practical commands (obtaining at least 22 score from the Mini-Mental Status Examination)
Mild spasticity in all involved upper limb joints (Modified Ashworth Scale less than 3)
Existence at least 20 degrees wrist extension and 10 degrees extension of the affected fingers</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of mirror therapy and modified constraint-induced movement therapy  before intervention
Refer to other clinics and receive other upper limb rehabilitation services
Despite previous dementia, difficulty understanding given explanations  and execute commands such as Wernicke aphasia, global aphasia, and any impairment of vision and hearing examinations by specialist
Presence of musculoskeletal damage, frozen shoulder joint and any other neurological and orthopedic disease based on examination of specialist who leads to motion impairment.
Excessive pain in the upper limb ( in this study the score  more than 4 in the Visual Analog Scale to be regarded as pain))
Botox injections at least 3 months before the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>VI</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: intervention performs 1 hour per day, five days per week, for a total of four weeks. The intervention sessions include performing tasks with upper limb. In addition to occupational therapy sessions the participants in this group will be asked to wear mitts and do functional tasks.</i_keyword>
      <i_keyword>Intervention group 2: intervention performs 1 hour per day, five days per week, for a total of four weeks. After adjusting the mirror, the image reflection of non-affected upper limb will be used in the mirror so that patient is placed in a sitting position and mirror is placed in front of the non-affected upper limb  and patient focuses on the image inside the mirror while practicing.</i_keyword>
      <i_keyword>Control group: common occupational therapy upper limb interventions that include Bobath, Rood and PNF Techniques will perform for 1 hour  per day, five days per week, for a total of four weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Upper extremity score based on Fugl-Meyer Assessment ". Timepoint: "Before the intervention, after the intervention, one month after the intervention.". Method of measurement: "Fugl-Meyer Assessment".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>"functional independence score". Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: "Functional Independence Measure".</sec_outcome>
      <sec_outcome>"Muscle Tone Score". Timepoint: "Before the intervention, after the intervention, one month after the intervention.". Method of measurement: "Modify Ashworth Scale".</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-13</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
