<?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>IRCT20180619040156N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-20</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effect of  cognitive and motor exercises  on improving the performance of chronic stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of environment̉al exercises (physical and virtual reality environment) on the brain reorganization, molecular parameters and behavioral functions (cognitive and motor) in the chronic stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>3</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34241</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: trials are double-blind, which means that neither Data analyser nor the outcome assessors know which people are getting which treatments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Stroke patients receiving cognitive-motorized physical training in the physical environment and rehabilitation routine interventions. Intervention 2: Intervention group: Stroke patients undergoing cognitive-motor-physical exercises in the virtual reality environment and rehabilitation routine interventions. Intervention 3: Control group:  Stroke patients receiving only rehabilitation routine interventions.</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:
In order to be trusted in the patient's personal information, their data is encoded and then shared with other researchers.

When:
After the completion of the design and documentation of the obtained data, the information is provided to the researchers. It takes about 1 year to complete this documentation.

To whom:
All researchers in the field of neurological diseases will have access to this information

Conditions:
Other researchers can access the information after submitting an abstract of their research plan.

Where to obtain:
by Email
sohailafallah66@gmail.com

How to obtain:
By submitting the abstract of the project and by email, it is provided

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheila Fallah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemat Highway, Iran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8862 2687</telephone>
        <email>fallah.s@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Fallah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemat Highway, Iran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8862 2687</telephone>
        <email>fallah.s@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Experience the first stroke
Passed for 6-24 months after lesion
Having ages between 35-65 years
Ability to walk at least 10 meters without auxiliary equipment
No history of falling over the past 6 months according to the patient's own report
Having an acceptable level of cognitive performance means a score of over 24 in the Mini Mental Status Examination (MMSE) test.
Not having hemi neglect using the Star Cancellation test
Not having any history of other neurological problems, orthopedics and upper limb surgeries involved according to medical records, patient's or patient's report or observation of the examiner
Having the criteria for receiving and consuming Atorvastatin drug on the basis of a neurologist's diagnosis
Central cerebral artery injury as the cause of stroke
Ability to read and write
Having understandable speech
The lack of vision problems has not been resolved</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Falling during assessments and exercises
Failure to cooperate properly and correct implementation of the instructions during the tests and exercises.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z82.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Family history of stroke</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: Stroke patients receiving cognitive-motorized physical training in the physical environment and rehabilitation routine interventions</i_keyword>
      <i_keyword>Intervention group: Stroke patients undergoing cognitive-motor-physical exercises in the virtual reality environment and rehabilitation routine interventions</i_keyword>
      <i_keyword>Control group:  Stroke patients receiving only rehabilitation routine interventions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance and upper and lower extremity mobility assessments (behavioral tests). Timepoint: Before interventions, immediately after intervention, 3 months after intervention. Method of measurement: Timed up go test, functional reach test, berg test, fugl meyer test.</prim_outcome>
      <prim_outcome>Cognitive Assessments (Behavioral Tests). Timepoint: Before interventions, immediately after intervention, 3 months after intervention. Method of measurement: Wechsler test, Wisconsin test, Stroop test.</prim_outcome>
      <prim_outcome>Serum levels of brain-derived growth factor (molecular laboratory tests). Timepoint: Before interventions, immediately after intervention, 3 months after intervention. Method of measurement: Brain derived neurotrophic factor analysis.</prim_outcome>
      <prim_outcome>Structural changes in various brain regions (laboratory imaging test). Timepoint: Before interventions, immediately after intervention, 3 months after intervention. Method of measurement: magnetic resonance imaging.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Changes in fear of falling. Timepoint: Before and after intervention and 3 months after intervention. Method of measurement: Activities-based balance confidence scale (ABC).</sec_outcome>
      <sec_outcome>Quality of life score. Timepoint: Before and after intervention and 3 months after intervention. Method of measurement: Short Form (36) Health Survey (SF-36).</sec_outcome>
      <sec_outcome>Changes in fatigue levels. Timepoint: Before and after intervention and 3 months after intervention. Method of measurement: Multidimensional Fatigue Symptom Inventory-Short Form.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-29</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat Highway . Iran University of Medical Sciences tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
