<?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>IRCT20190828044636N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-31</date_registration>
      <primary_sponsor>Self</primary_sponsor>
      <public_title>Effects of Supported Standing and Functional Electrical Stimulation in acute stroke</public_title>
      <acronym></acronym>
      <scientific_title>Conjunct effect of supported standing and functional electrical stimulation on strength and functional mobility in acute stroke:A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41797</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple random sampling technique was used .Computer generated randomization technique using the online sequence number generator for random allocation of patients in two groups has been used to collect the data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke.</hc_freetext>
      <i_freetext>Intervention group:Group A: Participents were treated with  conventional therapy (positioning, ROM exercises, bed mobility exercises) along with FES(Functional Electrical Stimulation) and supported standing by using tilt table initially later on standing frames and walkers for 30 minutes  once a day and five times a week for six weeks.Stimulation was applied by two channel comfy stimulators (model no EV-806).stimulations was applied by surface electrodes. Electrodes were applied at the points Gluteus Maximus,QuadricepsFemoris, Tibialis Anterior for 10 minutes each. Stimulation was applied at pulse rate of 40 Hz and pulse width of 180 µs.  Group B:  received conventional therapy (positioning, ROM exercises, and bed mobility exercises) along with supported standing by using tilt table initially later on standing frames and walkers for 30 minutes once a day and five times a week.  Both groups received treatment for six 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
data colleted from the primary outcomes only

When:
starting 6 months after publications. when it it will be published

To whom:
people working in academic and clinical practice

Conditions:
for clinical trial data can be shared

Where to obtain:
through email

How to obtain:
when any one want to review it and request  trough email than data will be provided

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadia Iftikhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no A-3, Muhallah Noor Pur Sharqi, Gujrat</address>
        <city>Gujrat</city>
        <country1>Pakistan</country1>
        <zip>50700</zip>
        <telephone>+92 53 3515229</telephone>
        <email>drsipt@gmail.com</email>
        <affiliation>Riphah International University lahore campus</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadia Iftikhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no A-3, Muhallah Noor Pur sharqi gujrat</address>
        <city>Gujrat</city>
        <country1>Pakistan</country1>
        <zip>50700</zip>
        <telephone>+92 53 3515229</telephone>
        <email>drsipt@gmail.com</email>
        <affiliation>Riphah International University lahore campus</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 30-65 years of age.
Adults with acute stroke.
Adults with ischemic stroke.
Patients able to react on verbal command.
Medically stable patient.
Patient was able to walk before stroke.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unstable cerebral perfusion.
Uncontrolled diabetes mellitus, hypertension and associated cardiac problems.
Associated problems in the limb e.g., deep vein thrombosis
Any orthopedic condition e.g., arthritis and fractures.
If the physiological variables (blood pressure, oxygen, heart rate, temperature) go beyond set safety limits and patients with severe fatigue</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Group A: Participents were treated with  conventional therapy (positioning, ROM exercises, bed mobility exercises) along with FES(Functional Electrical Stimulation) and supported standing by using tilt table initially later on standing frames and walkers for 30 minutes  once a day and five times a week for six weeks.Stimulation was applied by two channel comfy stimulators (model no EV-806).stimulations was applied by surface electrodes. Electrodes were applied at the points Gluteus Maximus,QuadricepsFemoris, Tibialis Anterior for 10 minutes each. Stimulation was applied at pulse rate of 40 Hz and pulse width of 180 µs.  Group B:  received conventional therapy (positioning, ROM exercises, and bed mobility exercises) along with supported standing by using tilt table initially later on standing frames and walkers for 30 minutes once a day and five times a week.  Both groups received treatment for six weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Strength. Timepoint: Baseline(before intervention) , After 6 weeks of intervention. Method of measurement: Manual muscle testing,The River Mead Mobility Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance and Functional mobility. Timepoint: Baseline(before intervention), After six weeks of intervention. Method of measurement: Berge Balance 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>self</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-10</approval_date>
        <contact_name>Institutional review board of Riphah International University Lahore campus</contact_name>
        <contact_address>28-M,Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
