<?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>IRCT20231108059998N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-08</date_registration>
      <primary_sponsor>University Of Lahore</primary_sponsor>
      <public_title>Effects of Interferential Therapy in addition to Routine Physical Therapy on Clinical and Physical Outcomes on Early postoperative Total Knee Arthroplasty</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Interferential current Therapy in addition to Routine Physical Therapy on Clinical and Physical Outcomes on Early postoperative Total Knee Arthroplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73670</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The scratch card method of randomization will be used to divide the participants into experimental groups at random. Each participant will be given a unique number. After that, each group will be assigned an arbitrary number of members, Blinding description: The trial will be single-blinded because the assessor will not know which group will get treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Early post-operative Rehabilitation for total knee arthroplasty patients unilaterally..</hc_freetext>
      <i_freetext>Intervention 1: Intervention GroupA(IFC+Routine Physical Therapy) is exposed to Interferential Current therapy (Model no:ES-522 ITO Physiotherapy Low and Medium Frequency Electrical Stimulation device) in addition to conventional physical therapy. .Conventional rehabilitation training group exercises including Routine physical therapy: Range of motion exercises, ankle pumps ,SLR-straight leg raise , knee iso-metrics , Quadriceps strengthening(knee press), heel press ,hamstring strengthening (clamshell )and partial to complete weight bearing in knee extension with knee immobilizer using walking aids . Walkers, knee supports like immbolizier will use to train the patient’s body posture stepping and Gait training session will last  for 20 minutes, twice a day,3 times a week for total of 1 week that is in-patient stay. Intervention 2: Control GroupB(Routine Physical Therapy): Conventional rehabilitation training group exercises including Routine physical therapy: Range of motion exercises, ankle pumps ,SLR-straight leg raise , knee iso-metrics , Quadriceps strengthening(knee press), heel press ,hamstring strengthening (clamshell )and partial to complete weight bearing in knee extension with knee immobilizer using walking aids . Walkers, knee supports like immbolizier will use to train the patient’s body posture stepping and Gait training session will last  for 20 minutes, twice a day,3 times a week for total of 1 week that is in-patient stay.</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 Due to Confidentiality and research ethics</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aqsa Aziz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 331 8446171</telephone>
        <email>aqsaaziz26@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ayesha Jamil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 324 4481031</telephone>
        <email>ayeshabutt031@gmail.com</email>
        <affiliation>University Of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female patients.
Age between 45 to 65 years.
Patients who are not exposed to IFC treatment pre-operatively.
Participants who has undergone total knee arthroplasty for the first time</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with causes as: Infections, Deep Vein thrombosis(DVT), Cancer and Epilepsy
Bone and joint diseases or serious diseases affecting organ function.
Any patient with pacemaker or any electrical stimulator device</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z96-65</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Z96-65</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention GroupA(IFC+Routine Physical Therapy) is exposed to Interferential Current therapy (Model no:ES-522 ITO Physiotherapy Low and Medium Frequency Electrical Stimulation device) in addition to conventional physical therapy. .Conventional rehabilitation training group exercises including Routine physical therapy: Range of motion exercises, ankle pumps ,SLR-straight leg raise , knee iso-metrics , Quadriceps strengthening(knee press), heel press ,hamstring strengthening (clamshell )and partial to complete weight bearing in knee extension with knee immobilizer using walking aids . Walkers, knee supports like immbolizier will use to train the patient’s body posture stepping and Gait training session will last  for 20 minutes, twice a day,3 times a week for total of 1 week that is in-patient stay.</i_keyword>
      <i_keyword>Control GroupB(Routine Physical Therapy): Conventional rehabilitation training group exercises including Routine physical therapy: Range of motion exercises, ankle pumps ,SLR-straight leg raise , knee iso-metrics , Quadriceps strengthening(knee press), heel press ,hamstring strengthening (clamshell )and partial to complete weight bearing in knee extension with knee immobilizer using walking aids . Walkers, knee supports like immbolizier will use to train the patient’s body posture stepping and Gait training session will last  for 20 minutes, twice a day,3 times a week for total of 1 week that is in-patient stay.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain,Range of Motion,Edema and Basic Functional Mobility. Timepoint: Baseline and 1st week. Method of measurement: Pain - Faces Wong Baker Pain Rating Scale ,Range of Motion - Goniometer,Edema - Measuring Tape and AM-PAC 6 clicks in-patient questionnaire used for Basic Functional Mobility .</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>2023-11-30</approval_date>
        <contact_name>Research Ethics committee- Faculty of Allied Health Sciences,The University of Lahore.</contact_name>
        <contact_address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
