<?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>IRCT20221214056821N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-07</date_registration>
      <primary_sponsor>Khyber Medical University</primary_sponsor>
      <public_title>Rehabilitation for anterior cruciate ligament reconstruction patients</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of early phase rehabilitation on outcomes of anterior cruciate ligament reconstruction in patients of tertiary care hospitals of Peshawar</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67511</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects will be randomly assigned to one of two groups using sealed envelope method: one (the experimental group) receiving the intervention, and the other (the comparison group or control) receiving an alternative (conventional) treatment, Blinding description: Due to nature of study, it will not be feasible to blind therapist and subjects. However, assessor, who will assess pre and post measurements, will be blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>ACL reconstruction rehabilitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Heel slides (slider board), Supine with legs up wall heels slides with gravity assisted, Bike pendulums: high seat circles forward and backward full circles lower seat Sitting passive leg extension with roll under heel OR prone leg hangs off end of bed Seated calf stretch with towel, knee bent (soleus), knee straight (gastrocnemius), Seated hamstring stretch (back straight), Quadriceps and hamstring co-contraction, Quadriceps isometrics in standing, sitting, lying +/– muscle stimulation or biofeedback, Sit to stand progress by gradually decreasing height of seat, Static lunge forward/side, Mini wall squat (30°), Side lying abduction and adduction, Gluteal squeezes supine or standing, Prone hip extension, Standing hip flexion and extension, abduction/adduction, Ankle pumping +/– with leg elevation,  Standing calf raises with and without support, Single leg stance 30 to 60 seconds, Wobble boards with support (table, bars, poles) through full ROM: side to side, forward and backward, Weight shifting: side to side and forward and backward, Progress from 2 crutches to 1, always maintaining normal walking pattern, Ice 15-25 minutes, Interferential current therapy (pain relief), Muscle Stimulation. Intervention 2: Control group: Icing 10-15 minutes, Gluteal squeezes supine or standing, Prone hip extension, standing hip flexion and extension, abduction and adduction, Ankle pumping +/– with leg elevation, standing calf raises with/without support, Single leg stance 30-60 seconds.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The institute as well as my patients I am working with is not allowing me to share data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mashal Gul</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>N Canal Rd, Abdarra, Peshawar, Khyber Pakhtunkhwa</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 9331105</telephone>
        <email>mashal.gul@ncs.edu.pk</email>
        <affiliation>NCS University System</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sarmad Saeed Khattak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>XCRP+W7C, 5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25100</zip>
        <telephone>+92 91 5838666</telephone>
        <email>sarmad.saeed@rmi.edu.pk</email>
        <affiliation>Rehman Medical Institute, Peshawar</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient underwent through ACL reconstruction surgery using hamstring and peroneus longus graft
Both males and females, aged 18 to 40 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with medial collateral ligament injuries, meniscal injuries &amp; infections.
Patients with known neurological diseases
Patients with known cognitive impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of unspecified cruciate ligament of knee</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: Heel slides (slider board), Supine with legs up wall heels slides with gravity assisted, Bike pendulums: high seat circles forward and backward full circles lower seat Sitting passive leg extension with roll under heel OR prone leg hangs off end of bed Seated calf stretch with towel, knee bent (soleus), knee straight (gastrocnemius), Seated hamstring stretch (back straight), Quadriceps and hamstring co-contraction, Quadriceps isometrics in standing, sitting, lying +/– muscle stimulation or biofeedback, Sit to stand progress by gradually decreasing height of seat, Static lunge forward/side, Mini wall squat (30°), Side lying abduction and adduction, Gluteal squeezes supine or standing, Prone hip extension, Standing hip flexion and extension, abduction/adduction, Ankle pumping +/– with leg elevation,  Standing calf raises with and without support, Single leg stance 30 to 60 seconds, Wobble boards with support (table, bars, poles) through full ROM: side to side, forward and backward, Weight shifting: side to side and forward and backward, Progress from 2 crutches to 1, always maintaining normal walking pattern, Ice 15-25 minutes, Interferential current therapy (pain relief), Muscle Stimulation.</i_keyword>
      <i_keyword>Control group: Icing 10-15 minutes, Gluteal squeezes supine or standing, Prone hip extension, standing hip flexion and extension, abduction and adduction, Ankle pumping +/– with leg elevation, standing calf raises with/without support, Single leg stance 30-60 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lower Extremity Function. Timepoint: Baseline Assessment and Assessment after 2 weeeks of intervention. Method of measurement: Lower Extremity Function Score.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Baseline Assessment and Assessment after 2 weeks of intervention. Method of measurement: Numeric Pain rating Scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Baseline Assessment and Assessment after 2 weeks of intervention. Method of measurement: Goniometer.</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>Khyber Medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-19</approval_date>
        <contact_name>AS&amp;RB (Advanced Studies &amp; Research Board) and ethical committee of Khyber Medical University</contact_name>
        <contact_address>Phase 5 Hayatabad Peshawar Khyber Pukhtoonkhawa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
