<?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>IRCT2015100224297N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-12</date_registration>
      <primary_sponsor>Vice chancellor for research, Center of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Compare the effect of task oriented training and conventional physiotherapy on balance in stroke pateints</public_title>
      <acronym>----</acronym>
      <scientific_title>Compare the effect of task oriented training and conventional physiotherapy on balance in hemiplegic patients following stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20542</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Task oriented training,three times a week for four weeks over twelve sessions. Each session takes about 2 hours. &#13;
1) sitting on a chair and reaching objects in all directions at a distance of more than arm's length; 2) forward, backward and side way stepping up; 3) flexion and extension the affected knee, while the affected foot located on the exercise step; 4) stepping  over obstacles with different heights; 5) standing up from a chair, walking four steps forward, touching a stool and then returning to the chair;  6) sitting on a Swiss ball while doing range of motion and balance exercise in the trunk and upper extremities; 7) double leg stand for 10 seconds; 8) tandem stand (the heel of one foot in front of the other foot) for 10 seconds; 9) standing up from a chair without using the arms; 10) tandem walking forward and backward7, 16. The four last exercises have been done in different situation as follows: 1) with open eyes and a hard surface, 2) with open eyes and a soft surface, 3) with closed eyes and hard surface; 4) with closed eyes and smooth surface. Intervention 2: Control group: conventional physiotherapy, three times a week for four weeks over twelve sessions. Each session takes about 2 hours.&#13;
Exercises to improve balance, increase muscle strength, range of motion and walking through weight training or weight transfer in the parallel bars, mats exercise  (strengthening, stretching, range of motion) and correct gait training in parallel bar.</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>Abbas Soltani Somee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy Department, Faculty of Rehabilitation, Vali Asr Blvd, Tavanir St, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3331 1293</telephone>
        <email>soltania@tbzmed.ac.ir</email>
        <affiliation>Faculty of Rehabilitation, Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Soltani Somee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy Department, Faculty of Rehabilitation, Vali Asr Blvd, Tavanir St, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3331 1293</telephone>
        <email>soltania@tbzmed.ac.ir</email>
        <affiliation>Faculty of Rehabilitation, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include:  hemiplegia secondary to stroke;  clear asymmetry in weight bearing;  the ability to independent walking for at least 10 meters;  passing less than three months after stroke and the Berg Balance Scale in the range of 30 to 40 and Exclusion criteria include: impaired vision; the absence of any neurological or orthopedic diseases affecting patients postural disorder and any disease that limited patient's participation in the study.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G96.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of central nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Task oriented training,three times a week for four weeks over twelve sessions. Each session takes about 2 hours. &#13;
1) sitting on a chair and reaching objects in all directions at a distance of more than arm's length; 2) forward, backward and side way stepping up; 3) flexion and extension the affected knee, while the affected foot located on the exercise step; 4) stepping  over obstacles with different heights; 5) standing up from a chair, walking four steps forward, touching a stool and then returning to the chair;  6) sitting on a Swiss ball while doing range of motion and balance exercise in the trunk and upper extremities; 7) double leg stand for 10 seconds; 8) tandem stand (the heel of one foot in front of the other foot) for 10 seconds; 9) standing up from a chair without using the arms; 10) tandem walking forward and backward7, 16. The four last exercises have been done in different situation as follows: 1) with open eyes and a hard surface, 2) with open eyes and a soft surface, 3) with closed eyes and hard surface; 4) with closed eyes and smooth surface</i_keyword>
      <i_keyword>Control group: conventional physiotherapy, three times a week for four weeks over twelve sessions. Each session takes about 2 hours.&#13;
Exercises to improve balance, increase muscle strength, range of motion and walking through weight training or weight transfer in the parallel bars, mats exercise  (strengthening, stretching, range of motion) and correct gait training in parallel bar</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional balance. Timepoint: Before and after treatment. Method of measurement: Berg Balance Scale.</prim_outcome>
      <prim_outcome>Sway. Timepoint: Before and after treatment. Method of measurement: The center of pressure path length and the center of pressure confidence ellipse area.</prim_outcome>
      <prim_outcome>Symmetry. Timepoint: Before and after treatment. Method of measurement: The plantar pressure distribution of foot.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>---. Timepoint: ---. Method of measurement: ---.</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 for research, Center of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-03</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Assistance Research and Technology, Third floor, Central Building (2), Tabriz University of Medical Sciences,  Golgasht St, Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
