<?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>IRCT20220628055308N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-02</date_registration>
      <primary_sponsor>King Edward Medical University, KEMU, Lahore, Pakistan</primary_sponsor>
      <public_title>Functional Outcomes After Total Hip Arthroplasty</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect Of Physiotherapy-Led Functional Exercise Regime vs. Conventional Therapy on Functional Outcomes After Total Hip Arthroplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64762</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: NA, Randomization description: Randomized Control Trial 
Computer generated table of random numbers

The sample was simply randomized into two equal groups  (1:1) by MS Excel. The patients were individually assigned group as per the randomization table generated. The randomization sequence was built by using a "Rand" function in MS Excel on the sample of 82 patients with equal distribution of 41 sample among the two groups. 
The "Rand" function can be used to generate random numbers. It will return a random number between 0 and 1. The syntax for the RAND function in Microsoft Excel is: RAND( ).

In 1st column of MS Excel spreadsheet,  patient numbers were written i.e. 82

In the 2nd column, groups were written. In this study either it's a functional exercise/ group A  or a conventional therapy group/ group B. The first 41 samples as functional exercise / group A and next 41 as conventional therapy group/ group B.

In 3rd column, Randomization formula was added which is between 0-1 by Inserting a function called "Rand" in the first row of 3rd column. MS Excel has added a random number to the cell. The random number was then added in the entire column by dragging though the cells. 
Column 2 and column 3 were filtered in order to randomize column 2. 
After this column 3 was filtered in ascending order from the options of top row header to randomize it. All the content in column 2 were randomized.
Likewise, all the patient numbers were randomized to either functional exercise/ group A or a conventional therapy group/ group B.   


The randomization table was generated by the other person and the group allotment of the participant was done by the other on the basis of concealed allocation. 
Allocation Concealment was carried out by sequentially numbered, opaque, sealed envelope (SNOSE) technique in which the randomization group were written on a paper and kept in an opaque sealed envelope. The envelope was labeled with a serial number. The investigator opens the sealed envelope once the patient has consented to participate and then assigns the treatment group accordingly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Total Hip Arthroplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Functional Exercise  (Those 41 participants  randomized to the intervention group will receive functional exercise under the supervision of the physiotherapist. Each session will be of approximately 35 minutes in length with 10 repetitions for a given exercises. Patients will attend the session twice weekly for 6 weeks, and will be given same exercises as a home exercise program. The functional exercise program in this study will be based on the following exercise plan: Sit to stand, Toe raises, Knee raises,  Side and back leg raises, Partial knee bends, Single knee bends, One legged standing balance and advanced one legged standing balance, Pelvic raising and lowering.). Intervention 2: Control group: Conventional Therapy Group  (Those randomized to the Group B will receive the conventional therapy protocol under the supervision of the physiotherapist. Each session will be of 35 minutes in length with 10 repetitions for a given exercises. Patients will attend the session twice weekly for 6 weeks and will be given same exercises as a home exercise plan. This will include the following exercise plan: Foot and ankle pumps, Static quadriceps  contractions, Static gluteal contractions, Active hip flexion, Active hip extension, Active hip abduction, Hip external rotations and Hamstring Curls.).</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 "There is no further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Samawiya Farooq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House Number 302, Opposite  JCO  Club,  R.A.Bazaar,  Rawalpindi  Cantt</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 334 5444098</telephone>
        <email>samawiyafarooq@gmail.com</email>
        <affiliation>King Edward Medical University, KEMU, Lahore, Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Samawiya Farooq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House Number 302, Opposite JCO  Club,  R.A.Bazaar,  Rawalpindi  Cantt</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 334 5444098</telephone>
        <email>samawiyafarooq@gmail.com</email>
        <affiliation>King Edward Medical University, KEMU,  Lahore, Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 30 to 60 years
Total hip arthroplasty
1 to 16 weeks after THA
Able to understand instructions
Willing to come for all follow-ups</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Tumor / cancer
Total knee replacement
Revision arthroplasty surgery
Any underlying terminal disease
Suspicion of infection following joint replacement</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z96.64</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of artificial hip joint</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: Functional Exercise  (Those 41 participants  randomized to the intervention group will receive functional exercise under the supervision of the physiotherapist. Each session will be of approximately 35 minutes in length with 10 repetitions for a given exercises. Patients will attend the session twice weekly for 6 weeks, and will be given same exercises as a home exercise program. The functional exercise program in this study will be based on the following exercise plan: Sit to stand, Toe raises, Knee raises,  Side and back leg raises, Partial knee bends, Single knee bends, One legged standing balance and advanced one legged standing balance, Pelvic raising and lowering.)</i_keyword>
      <i_keyword>Control group: Conventional Therapy Group  (Those randomized to the Group B will receive the conventional therapy protocol under the supervision of the physiotherapist. Each session will be of 35 minutes in length with 10 repetitions for a given exercises. Patients will attend the session twice weekly for 6 weeks and will be given same exercises as a home exercise plan. This will include the following exercise plan: Foot and ankle pumps, Static quadriceps  contractions, Static gluteal contractions, Active hip flexion, Active hip extension, Active hip abduction, Hip external rotations and Hamstring Curls.)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before Intervention and 6 Weeks After Intervention. Method of measurement: VAS &amp; WOMAC pain score.</prim_outcome>
      <prim_outcome>Stiffness. Timepoint: Before Intervention and 6 Weeks After Intervention. Method of measurement: WOMAC Stiffness score.</prim_outcome>
      <prim_outcome>Physical Functioning. Timepoint: Before Intervention and 6 Weeks After Intervention. Method of measurement: WOMAC  Physical Functioning score.</prim_outcome>
      <prim_outcome>Functional Outcomes. Timepoint: Before Intervention and 6 Weeks After Intervention. Method of measurement: WOMAC scores.</prim_outcome>
      <prim_outcome>Health Related Quality of Life. Timepoint: Before Intervention and 6 Weeks After Intervention. Method of measurement: SF-12 Scores.</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>King Edward Medical University, KEMU, Lahore, Pakistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-08</approval_date>
        <contact_name>Institutional Review Board, KEMU, Lahore</contact_name>
        <contact_address>Neelagumbad, Anarkali, Lahore Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
