<?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>IRCT20211011052727N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-10</date_registration>
      <primary_sponsor>Capital Medical University/ China Rehabilitation and Research Center</primary_sponsor>
      <public_title>Effectiveness of Gait Training Exercises for Post-Stroke Gait Pattern Improvement</public_title>
      <acronym></acronym>
      <scientific_title>Stepping Forward: Evaluating the Impact of Gait Training on Post-Stroke Patients' Energy Cost of Walking</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69063</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Quasi experimental pre-test post-test study design.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sub acute stroke patients with level 3 on functional ambulatory category.</hc_freetext>
      <i_freetext>Intervention group: As this study will involve only one group, all eligible patients will receive an intervention consisting of gait training exercises. These exercises will include range of motion exercises, lower limb strengthening exercises, stepping over obstacles, side stepping gait exercises, target stepping, and retro walking. Each exercise session will last 60 minutes, and patients will receive gait training exercise intervention three times per week. The study will last for a total of six weeks, during which patients will participate in a total of 18 gait training exercise sessions.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Salman Farooqi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>264 F6, Phase 6 Hayatabad</address>
        <city>Hayatabad Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25100</zip>
        <telephone>+92 91 5823496</telephone>
        <email>salmankmu@gmail.com</email>
        <affiliation>Khyber Medical University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Salman Farooqi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>264 F6, Phase 6 Hayatabad</address>
        <city>Hayatabad Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25100</zip>
        <telephone>+92 91 5823496</telephone>
        <email>salmankmu@gmail.com</email>
        <affiliation>Khyber Medical University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients having history of stroke at least 3 months before the start of the study.
Stroke patients having the capability to walk Independently (with or without assisted devices). With a score of 3 or above on Fictional Ambulatory Category (FAC)
Patients having mini mental status score greater then 24
Medically stable patients with no known case of uncontrolled Hypertension, arrhythmia, or unstable cardiovascular diseases
No significant Musculoskeletal problems relating to conditions other than stroke
Patients having the age of 18 or above were included in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients with major psychological disorders or inability to follow commands were excluded from study.
Patients with history of Myocardial Infarction before stroke or known case of angina were excluded
Patients having previous history of Chronic obstructive pulmonary disease (COPD), or other chronic respiratory disorders were excluded from the study
Patient who experienced pain during walking.•	Stroke patients with the history of unliteral neglect was also excluded.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G81.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemiplegia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: As this study will involve only one group, all eligible patients will receive an intervention consisting of gait training exercises. These exercises will include range of motion exercises, lower limb strengthening exercises, stepping over obstacles, side stepping gait exercises, target stepping, and retro walking. Each exercise session will last 60 minutes, and patients will receive gait training exercise intervention three times per week. The study will last for a total of six weeks, during which patients will participate in a total of 18 gait training exercise sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The walking energy cost of stroke patients. Timepoint: the walking energy cost will be calculated before intervention then at 3 weeks post intervention and finally at the end of 6th week of intervention. Method of measurement: The walking energy cost of stroke patients will be calculated using the Physiological cost index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of spasticity. Timepoint: pre intervention and post intervention. Method of measurement: Modified Ashworth 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>Capital Medical University/ China Rehabilitation and Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-05</approval_date>
        <contact_name>Ethical committe of the institute of physical medicine and rehabilitation khyber medical university</contact_name>
        <contact_address>Phase 5 street 1 Hayatabad Peshawar Khyber Medical University Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
