<?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>IRCT20200331046903N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-21</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>EFFECTS OF QUADRICEPS KINETIC EXERCISES AT SPECIFIC KNEE ANGLE IN PATIENTS WITH POST-SURGICAL ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: A RANDOMIZED CONTROLLED TRIAL</public_title>
      <acronym></acronym>
      <scientific_title>EFFECTS OF QUADRICEPS KINETIC EXERCISES AT SPECIFIC KNEE ANGLE IN PATIENTS WITH POST-SURGICAL ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: A RANDOMIZED CONTROLLED TRIAL</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46959</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subject fulfilling the inclusion criteria will be enrolled by independent outcome assessor then lottery method will be used for randomization. Each member of the population will be number systematically and in consequent manner by writing each number on a separate piece of paper. These pieces of paper are mixed and put into a box and then numbers are drawn out of the box in a random manner. The subject’s randomization method will reduce the chances of group bias allocation, Blinding description: The study is single blinded in which outcome assessor will be kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anterior Cruciate ligament Reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled alternate quad and hamstring activity in open kinematic chain (OKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises. Intervention 2: Intervention group 2. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled squats in closed kinematic chain (CKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises. Intervention 3: Intervention group 3. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled squats in closed kinematic chain (CKC) &amp; controlled alternate quad and hamstring activity in open kinematic chain (OKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises.</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:
IPD collected for the primary outcome measure only

When:
after the publication of the study

To whom:
academic institutions and researcher

Conditions:
on informed request from the investigators

Where to obtain:
via email or telephonic contact with investigator

How to obtain:
on email request, data will be provided with in week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Danish Ali Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1- Km Raiwind Rd, Sultan Town, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54792</zip>
        <telephone>+92 42 35963424</telephone>
        <email>dani_ak_pk@hotmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof Dr Ashfaq Ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1- Km Raiwind Rd, Sultan Town, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54792</zip>
        <telephone>+92 42 35963424</telephone>
        <email>ashfaaqpt@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 20-50 years
Both male and female patients
Patients having Unilateral  Anterior Cruciate Ligament reconstruction
Healthy Contralateral leg
ACL reconstruction surgery
Ability to walk with or without an assistive device</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any previous knee injury
History of dislocation hip
Concomitant injury
Posterior Cruciate ligament Tear
Any rheumatologic conditions (osteoarthritis, rheumatoid arthritis),
Any trauma or meniscus injury
History of Ligamentous instability at knee
History of referred pain from the lumbar spine, hip, pelvis and sacroiliac regions
Patients with history of  remarkable knee joint inflammation and effusion,
Patients with history of Hyperextension of knee joint
Patients with history of polio paralysis
Previous History of physiotherapy session for knee treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.519A</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of anterior cruciate ligament of unspecified knee, initial encounter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled alternate quad and hamstring activity in open kinematic chain (OKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises.</i_keyword>
      <i_keyword>Intervention group 2. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled squats in closed kinematic chain (CKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises.</i_keyword>
      <i_keyword>Intervention group 3. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled squats in closed kinematic chain (CKC) &amp; controlled alternate quad and hamstring activity in open kinematic chain (OKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention and 6, 12 and 24 weeks after intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Knee Function. Timepoint: before intervention and 6, 12 and 24 weeks after intervention. Method of measurement: Lysholm Knee Scoring scale.</prim_outcome>
      <prim_outcome>Range of Motion. Timepoint: before intervention and 6, 12 and 24 weeks after intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Recurrence of Anterior Cruciate Ligament. Timepoint: before intervention and 6, 12 and 24 weeks after intervention. Method of measurement: Lachman Test.</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>University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-22</approval_date>
        <contact_name>Institutional Review Board of University Institute of Physical therapy University of Lahore</contact_name>
        <contact_address>1- Km Raiwind Rd, Sultan Town, Lahore, Punjab Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
