<?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>IRCT20160424027562N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-06</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of training in chronic stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of eccentric training on knee muscles torque and functional tests in chronic stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35884</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be simple and individually. It will be performed by selecting a closed envelope by every patient, enrolling him/her to the experimental or control group, Blinding description: In this study, participants and outcome assessor will be blind. Despite explained to patients adequately about the intervention, they will not be aware of being in the intervention or control group. The outcome assessor will be the person other than the main investigator to reduce the bias in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the experimental group will walk on the treadmill with a negative 10% inclination for 30 minutes. In the first week, they will walk on the treadmill as fast as 55% of maximum heart rate and also they will walk in the second week with 65% of maximum heart rate and in the third week with 75% and in the fourth week with 85% maximum heart rate. Participants in addition to walking on their treadmill, undergo routine physiotherapy (functional electrical stimulation of Quadriceps muscle for 10 minutes, balance exercises with tilt board, stretch training of the Gastrocnemius muscle for 15 seconds, and training in daily activities). Training will be performed three times in the weeks for four weeks. Intervention 2: Control group: Participants undergo routine physiotherapy (functional electrical stimulation of Quadriceps muscle for 10 minutes, balance exercises with tilt board, stretch training of the Gastrocnemius muscle for 15 seconds, and training in daily activities). Training will be performed three times in the weeks for 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roghayeh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>mohamadipt@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghayeh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23333654180</telephone>
        <email>mohamadipt@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All the patients should be more than 6 months poststroke
The spasticity score of plantarflexor muscles should be smaller than 2 in the modified Ashworth scale
Stroke patients should be in the chronic stage
They should be able to walk on treadmill</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Medical condition (apart from stroke) that impair patients balance
Aphasia
Cognition deficiency</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I67.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebrovascular disease, unspecified</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: Participants in the experimental group will walk on the treadmill with a negative 10% inclination for 30 minutes. In the first week, they will walk on the treadmill as fast as 55% of maximum heart rate and also they will walk in the second week with 65% of maximum heart rate and in the third week with 75% and in the fourth week with 85% maximum heart rate. Participants in addition to walking on their treadmill, undergo routine physiotherapy (functional electrical stimulation of Quadriceps muscle for 10 minutes, balance exercises with tilt board, stretch training of the Gastrocnemius muscle for 15 seconds, and training in daily activities). Training will be performed three times in the weeks for four weeks.</i_keyword>
      <i_keyword>Control group: Participants undergo routine physiotherapy (functional electrical stimulation of Quadriceps muscle for 10 minutes, balance exercises with tilt board, stretch training of the Gastrocnemius muscle for 15 seconds, and training in daily activities). Training will be performed three times in the weeks for four weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quadriceps muscle torque on the affected side. Timepoint: Before intervention, and 4 weeks after intervention. Method of measurement: Isokinetic System.</prim_outcome>
      <prim_outcome>Hamsrings muscle torque on the affected side. Timepoint: Before intervention, and 4 weeks after intervention. Method of measurement: Isokinetic System.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time of the Timed Up and Go test. Timepoint: Before intervention, and 4 weeks after intervention. Method of measurement: Chronometer.</sec_outcome>
      <sec_outcome>Berg Balance Scale. Timepoint: Before intervention, and 4 weeks after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Functional Reach Test. Timepoint: Before intervention, and 4 weeks after intervention. Method of measurement: Ruler.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-18</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
