<?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>IRCT20190913044760N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-29</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rehabilitation program on intensive care unit acquired weakness</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rehabilitation program on intensive care unit acquired weakness</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65581</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients will be allocated to two control and intervention groups using the block random allocation method with blocks of 4 of equal size and a combination of even numbers for the intervention group and odd numbers for the control group. For this purpose, a table of odd and even numbers has been prepared without a specific pattern and order, and thus the allocation method is determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>intensive care unit acquired weakness.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the intensive care unit of Imam Khomeini  hospital, as a control, patients and their guardians are asked to complete the study tools after obtaining informed consent. The above process will continue until reaching the determined sample size. Intervention 2: Intervention group: In the Intensive care unit of Imam Khomeini Hospital, the instrument under study is completed after obtaining informed consent from the patients who meet the entry criteria or their guardians. Then the physical therapy of the organs is performed for 14 days, twice a day (10 AM- 4PM) for 20 minutes under the supervision of a physiotherapist. The study tool will be completed again at the end of the 14th day.In case of transfer to the ward, the intervention will continue until the end of the 14th day.</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 unidentifiable data can be provided if required

When:
Access period starts 6 months after the results are published

To whom:
All researchers working in scientific institutes and universities who send requests

Conditions:
The data can be used in accordance with copyright law and for further research in this field

Where to obtain:
Send an email to Mr.Mohammad Amin Matufi Azar at amin76tums@gmail.com

How to obtain:
After reviewing the application and the applicant's conditions, if approved, the data will be sent within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Amin Matufi Azar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zafar street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911735547</zip>
        <telephone>+98 21 2226 1540</telephone>
        <email>amin76tums@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Abasi Dolatabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirkhani Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4329</telephone>
        <email>zahra_abasi2000@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 18 to 60 years
written consent from patient or her/his guardian
admission to the intensive care unite
Body mass index Below 35 kg/m2
written doctor`s order to perform rehabilitation
level of consciousness based on glasgow coma test above 10
stable hemodynamic status
Absence of background diseases such as myasthenia gravis
no damage to the spine</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>death of the patient
Entering the acute stages of the disease
Hemodynamic instability
diagnosed with Deep vein thrombosis
Unwillingness to cooperate on behalf of the patient or her/his guardian</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G72.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Critical illness myopathy</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: In the intensive care unit of Imam Khomeini  hospital, as a control, patients and their guardians are asked to complete the study tools after obtaining informed consent. The above process will continue until reaching the determined sample size.</i_keyword>
      <i_keyword>Intervention group: In the Intensive care unit of Imam Khomeini Hospital, the instrument under study is completed after obtaining informed consent from the patients who meet the entry criteria or their guardians. Then the physical therapy of the organs is performed for 14 days, twice a day (10 AM- 4PM) for 20 minutes under the supervision of a physiotherapist. The study tool will be completed again at the end of the 14th day.In case of transfer to the ward, the intervention will continue until the end of the 14th day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Index of muscle weakness, muscle strength and deep tendon`s reflexe. Timepoint: Before and after intervention. Method of measurement: Using the Medical Research Council questionnaire for muscle weakness (MRC), which measures the flexion and extension movement of 6 muscle groups as points and is scored from 0 to 60, and a score below 48 is considered muscle weakness.</prim_outcome>
      <prim_outcome>The effect of rehabilitation program on muscle strength. Timepoint: Before and after intervention. Method of measurement: Using a tool called a handgrip dynamometer is used to measure hand strength based on kilograms.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The effect of rehabilitation program on deep tendon reflex. Timepoint: Before and after intervention. Method of measurement: Using a questionnaire called DTR, the tendon reflex of the biceps, triceps, brachioradialis, knee and ankle muscles is measured from 0 to +4.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-15</approval_date>
        <contact_name>Ethics Committee of Imam Khomeini Hospital of Tehran University of Medical Sciences</contact_name>
        <contact_address>58 / 5,000 Translation results Keshavarz Blvd., Doctor Gharib St., Imam Khomeini Hospital Complex Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
