<?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>IRCT20220806055629N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-29</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effects of a dual-task exercise course with and without ankle-foot orthosis on walking retraining in stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of a dual-task exercise course with and without ankle-foot orthosis on walking retraining in stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65650</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used to assign the participants to two groups of sixteen. In the block randomization method, we create blocks of four and randomly select a block of four for each four people. The block modes of four are as follows: AABB, ABAB, ABBA, BAAB, BABA, BBAA. We randomly choose one of the six quadruple block modes. For example, if the first mode is AABB, the first and second players are in group A, and the third and fourth players are in group B. We put them in the envelope and number each one from 1 to 32.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: performing dual-task exercises along with wearing ankle-foot orthosis. Patients receive therapeutic interventions for two weeks and 5 sessions per week. Dual-task exercises are performed for 30 minutes and 5 times a week, with 3-4 repetitions each time. Intervention 2: Control group: only performing dual-task exercises. Patients receive therapeutic interventions for two weeks and 5 sessions per week. Dual-task exercises are performed for 30 minutes and 5 times a week, with 3-4 repetitions each time.</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:
It is not possible to share all the data and only the demographic information of the participants and the results of the study evaluation variables are shared.

When:
The data access period starts 6 months after the publication of the article

To whom:
Working researchers and students in academic centers

Conditions:
Other researchers as well as therapists in the field of medicine and rehabilitation can use this study after printing the article.

Where to obtain:
Negin Mizangir

How to obtain:
After requesting the documents, the person in charge of the research project must receive written permission from the university and send the documents after obtaining the permission. Therefore, the data will be sent approximately 6 months after the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Mizangir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 2057</telephone>
        <email>neginmz09@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negin Mizangir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 2057</telephone>
        <email>neginmz09@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All participants are stroke patients that at least six months and at most one year have passed since their stroke.
Having normal/healthy Hearing and vision
Absence of neurological disorders and pain while walking
Be able to follow verbal instructions and provide verbal responses to questions
No previous history of using any type of orthosis
The degree of spasticity of the gastrosoleus muscle should be less than 2 according to the Ashworth scale
Having the ability to walk independently for at least 12 meters with or without the use of an aid such as a cane or a walker
Needing to gait training under the supervision of a physiotherapist</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of balance deficits unrelated to stroke
Individuals with very poor balance
Inability to perform the cognitive task used in the dual walking task
Severe cognitive deficits
Any complex medical history that could interfere with the intervention such as pulmonary problems or Orthopedic disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I60-I69</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebrovascular diseases</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: performing dual-task exercises along with wearing ankle-foot orthosis. Patients receive therapeutic interventions for two weeks and 5 sessions per week. Dual-task exercises are performed for 30 minutes and 5 times a week, with 3-4 repetitions each time.</i_keyword>
      <i_keyword>Control group: only performing dual-task exercises. Patients receive therapeutic interventions for two weeks and 5 sessions per week. Dual-task exercises are performed for 30 minutes and 5 times a week, with 3-4 repetitions each time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Walking speed. Timepoint: At the beginning of the study and after three weeks of intervention. Method of measurement: 3D analysis motion system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Kinematic parameters of ankle, knee and hip joints. Timepoint: At the beginning of the study and after three weeks of intervention. Method of measurement: 3D analysis motion system.</sec_outcome>
      <sec_outcome>Kinetic parameters of ankle, knee and hip joints. Timepoint: At the beginning of the study and after three weeks. Method of measurement: 3D analysis motion system and force plate.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-24</approval_date>
        <contact_name>Research Ethic Committees of Vice Chancellor in Research Affairs Shahid Beheshti University of Medic</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
