<?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>IRCT20200225046616N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-15</date_registration>
      <primary_sponsor>The university of Lahore</primary_sponsor>
      <public_title>Equal weight bearing sit-to-stand exercise in stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of routine physical therapy with and without equal weight bearing sit-to-stand exercise program on balance and functional independence in stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50122</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: No, Randomization description: 28 participant were allocated in control or experimental group by simple randomization method at individual level. A random sequence for patients allocation was generated on computer using commentpicker.com. Each number was kept in a sealed envelope. For each patient a sealed envelope was opened and according to mentioned number, group was allocated. No allocation concealment was carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 3 sessions per week for 2 months of routine physical therapy treatment that includes electrical stimulation, Muscles Stretching, Strengthening and range of Motion Exercises for 45-60 minutes. In one session, electrical stimulation and Hot pack was given for 15 minutes. Static stretching of affected muscles was performed according to the participant requirement. The muscle strengthening exercises included loading of affected leg with unaffected leg placed on a wooden block, stepping up exercise with the affected leg (stepping up a wooden block with the affected leg), stepping down with the affected leg, heels lift. Fifteen repetitions of each exercise was given with a resting period of 1 minute between exercises. Intervention 2: Intervention group: 3 sessions per week for 2 months of routine physical therapy with equal weight bearing sit-to-stand exercise for 45-60 minutes. In one session, routine physiotherapy mentioned above was given with equal weight bearing Sit-to-stand exercise (20 rep). In Sit-to-stand exercise affected foot positioned alongside the unaffected foot rising with chair arm-rest assistance.</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:
All collected deidentified IPD

When:
Data will be available to other people after the completion of study and remained available till 3
months

To whom:
Data will be available to people working in academic institutions

Conditions:
"Fariha Khalid" 
Institutional email address: fariha.khalid@dhpt.uol.edu.pk

Where to obtain:
"Fariha Khalid" 
Institutional email address: fariha.khalid@dhpt.uol.edu.pk

How to obtain:
Data can be accessed by communicating with principle investigator "Fariha Khalid" through
institutional email address: fariha.khalid@dhpt.uol.edu.pk

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Fariha khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54590</zip>
        <telephone>+92 42 99200600</telephone>
        <email>farihakhalid93@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Fariha khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Lahore, Main Campus, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54590</zip>
        <telephone>+92 42 99200600</telephone>
        <email>farihakhalid93@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Clinically diagnosed stroke patients by neurologist
Sub-acute stage (between 2 weeks to 6 months after onset)
Both males and females aged 40-60 years
Both hemorrhagic or ischemic types
Able to understand command and have the capacity to provide informed consent</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Musculoskeletal Disorder i.e. Substantial loss of joint range due to arthritis etc
Unstable Angina
Participation in other interventional or pharmacological studies which can affect the results of this study
Disability or other comorbid disease such as cancer or amputation that will limit or prevent assessment of the patients
Previous history of neurological disease other than stroke</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63.50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebral artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 3 sessions per week for 2 months of routine physical therapy treatment that includes electrical stimulation, Muscles Stretching, Strengthening and range of Motion Exercises for 45-60 minutes. In one session, electrical stimulation and Hot pack was given for 15 minutes. Static stretching of affected muscles was performed according to the participant requirement. The muscle strengthening exercises included loading of affected leg with unaffected leg placed on a wooden block, stepping up exercise with the affected leg (stepping up a wooden block with the affected leg), stepping down with the affected leg, heels lift. Fifteen repetitions of each exercise was given with a resting period of 1 minute between exercises.</i_keyword>
      <i_keyword>Intervention group: 3 sessions per week for 2 months of routine physical therapy with equal weight bearing sit-to-stand exercise for 45-60 minutes. In one session, routine physiotherapy mentioned above was given with equal weight bearing Sit-to-stand exercise (20 rep). In Sit-to-stand exercise affected foot positioned alongside the unaffected foot rising with chair arm-rest assistance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before intervention, 4th week of intervention, 8th week of intervention. Method of measurement: Berg balance scale.</prim_outcome>
      <prim_outcome>Functional independence. Timepoint: Before intervention, 4th week of intervention, 8th week of intervention. Method of measurement: Functional independence measure scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>The university of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-30</approval_date>
        <contact_name>Ethic's committee of University of Lahore</contact_name>
        <contact_address>1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
