<?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>IRCT20140304016830N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  task-oriented balance exercises on balance of patients with chronic stroke</public_title>
      <acronym></acronym>
      <scientific_title>A randomized controlled trial to comparative study of the effect of single and dual cognitive task-oriented balance exercises on postural control and functional balance in subjects with chronic stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29041</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed by the person who is not involved in the study using sequentially numberd sealed envelopes, Blinding description: Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind on the groups allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke.</hc_freetext>
      <i_freetext>Intervention 1: Control group: receives conventional rehabilitation (including exercises for upper and lower limb stretching, range of motion and activities of daily living). Intervention 2: First intervention group: ُSingle task-oriented balance exercises group that receives 24 sessions of single task-oriented balance exercises (8 weeks, 3 sessions per week, 60 to 90 minutes per session) in addition to the conventional rehabilitation. Single task-oriented balance exercises include three types of standing, transferring and walking activities which performed based on two principals of difficulty level of motor task and individual safety. Intervention 3: Second Intervention group:  cognitive dual task-oriented balance exercises group that receives 24 sessions of cognitive dual task-oriented balance exercises (8 weeks, 3 sessions per week, 60 to 90 minutes per session) in addition to the conventional rehabilitation. In this group, task-oriented balance exercises (including three types of standing, transferring and walking activities based on two principals of difficulty level of motor task and individual safety) are performed simultaneously with cognitive tasks (e.g., backward counting, saying the days of the week and the months of the year in reverse order, etc.).</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:
After the completion of this study, a manuscript regarding the documentation and the results of the study will be prepared and published.  If more details are needed, individuals can send their request by email to the person responsible for scientific accountability.

When:
8 months after publishing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Use of the documentation is permitted upon written permission.

Where to obtain:
Ghorban Taghizadeh
Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tel: 00982122227124
E-mail: taghizadeh.gh@iums.ac.ir

How to obtain:
Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghorban Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>taghizadeh.gh@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghorban Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>taghizadeh.gh@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the first experience of stroke
Passing 6-24 months since stroke
Having an ability to walk at least 10 meters without assistive devices
Having the ability to perform the most difficult condition of laboratory test (quiet standing on foam surface with closed eyes while performing cognitive task)
Having an acceptable level of cognitive function, i.e. score equal to or greater than 23 on the Mini Mental State Examination</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having unilateral visuospatial neglect (i.e., obtaining score less than 44 at star cancellation test)
Co-morbid other neurological diseases
Having orthopedic disorders (such as low back pain, arthritis and flat foot)
Having diabetes according to the report of patient, or the patient's family or physician
Having addiction according to the report of patient, or the patient's family or physician</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I64</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>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: receives conventional rehabilitation (including exercises for upper and lower limb stretching, range of motion and activities of daily living).</i_keyword>
      <i_keyword>First intervention group: ُSingle task-oriented balance exercises group that receives 24 sessions of single task-oriented balance exercises (8 weeks, 3 sessions per week, 60 to 90 minutes per session) in addition to the conventional rehabilitation. Single task-oriented balance exercises include three types of standing, transferring and walking activities which performed based on two principals of difficulty level of motor task and individual safety.</i_keyword>
      <i_keyword>Second Intervention group:  cognitive dual task-oriented balance exercises group that receives 24 sessions of cognitive dual task-oriented balance exercises (8 weeks, 3 sessions per week, 60 to 90 minutes per session) in addition to the conventional rehabilitation. In this group, task-oriented balance exercises (including three types of standing, transferring and walking activities based on two principals of difficulty level of motor task and individual safety) are performed simultaneously with cognitive tasks (e.g., backward counting, saying the days of the week and the months of the year in reverse order, etc.).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional balance. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Berg Balance Scale Questionnaire, Tinetti Balance test.</prim_outcome>
      <prim_outcome>Postural control. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Force plate (postural sway parameters).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional mobility. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Single and dual Timed Up &amp; Go Test, Dynamic gait index Questionnaire.</sec_outcome>
      <sec_outcome>Cognitive function. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Wechsler memory 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-08</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, 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>
