<?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>IRCT20231017059755N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-09</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effect of Alfredson vs Silbernagel eccentric protocol on clinical outcomes in Amateur players with Achilles tendinopathy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Alfredson vs Silbernagel eccentric protocol on clinical outcomes in Amateur players with Achilles tendinopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73234</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The mechanics of randomization play a crucial role in ensuring unbiased comparisons between the two interventions. The method of randomization refers to the technique used to allocate participants to the different treatment groups is :
Simple Randomization: A basic method where each participant has an equal chance of being assigned to the protocol group. 
Tool can be used for randomization is Random Number Tables
in which  each number has an equal chance of being selected. These tables can use to assign participants randomly.
The random sequence is built based on the chosen method of randomization. For simple randomization, a list of random numbers can be generated, Blinding description: An independent assessor, who will be a senior and experienced physiotherapist and further will not be the part of study will perform the assessment of patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Achilles tendinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Group A: Patients will be instructed about the treatment procedures. The Alfredson isolated eccentric exercise program, which comprises 4 weeks of eccentric heel-drops on the injured limb, with the use of the uninjured limb to concentrically return to the start position. Exercises will be performed twice daily, for three sets of 15 repetitions, both with a straight and bent knee (i.e. 180 repetitions each day). Non-disabling pain during the exercises will be permitted, and load added gradually in a backpack (in steps of 5 kg) when exercises can be performed without pain. Intervention 2: Group B: This group will receive  Silbernagel protocol comprises various concentric and eccentric heel raise exercises, which are performed both on two legs and one leg, with three sets of 15 repetitions. The duration of the program is also 4 weeks, and non-disabling pain during the exercises is also permitted, but contrary to the Alfredson program, exercises are performed only once daily. Progression is made by changing from bipedal to unipedal exercises, by progressing from concentric-eccentric to purely eccentric loading, by adding weight in a backpack (in steps of 5 kg when pain did not exceed 5 on a 0–10 numerical rating scale), and finally by using fast-rebounding and plyometric 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:
All collected identified IPD

When:
Data will be available after the completion of study and will remain available till 6 months

To whom:
Data will be available for other people almost 6 months after the completion of study

Conditions:
The data/document could be used by communicating with the principle investigator "Mehak Amjad" on email address "mehakamir50@gmail.com".

Where to obtain:
Mehak Amjad, mehakamir50@gmail.com

How to obtain:
The data/document can be accessed through communicating with the principle investigator "Mehak Amjad" on email address "mehakamir50@gmail.com".

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehak Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The university of Lahore main campus near bhobatian chowk</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 302 6965902</telephone>
        <email>mehakamir50@gmail.com</email>
        <affiliation>The University of Lahore, Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehak Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-km, Defence Road, Off Bhobatian Chowk , Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 302 6965902</telephone>
        <email>mehakamir50@gmail.com</email>
        <affiliation>The university of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18-40 years
Both male and female
Grade 1, Grade 2 – Tendinopathy (grade 1 represents a normal tendon; grade 2 an enlarged tendon).
Clinical diagnosis of Achilles tendinopathy
Arc test, Thompson test, RLH test are diagnostic tests</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Achilles tendon rupture
History of invasive intervention for AT on more painful side
Diagnosed systemic inflammatory conditions (e.g. rheumatoid arthritis, ankylosing spondylitis)
Any other lower limb pathology</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76. 60</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>used to indicate a diagnosis for reimbursement purposes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group A: Patients will be instructed about the treatment procedures. The Alfredson isolated eccentric exercise program, which comprises 4 weeks of eccentric heel-drops on the injured limb, with the use of the uninjured limb to concentrically return to the start position. Exercises will be performed twice daily, for three sets of 15 repetitions, both with a straight and bent knee (i.e. 180 repetitions each day). Non-disabling pain during the exercises will be permitted, and load added gradually in a backpack (in steps of 5 kg) when exercises can be performed without pain.</i_keyword>
      <i_keyword>Group B: This group will receive  Silbernagel protocol comprises various concentric and eccentric heel raise exercises, which are performed both on two legs and one leg, with three sets of 15 repetitions. The duration of the program is also 4 weeks, and non-disabling pain during the exercises is also permitted, but contrary to the Alfredson program, exercises are performed only once daily. Progression is made by changing from bipedal to unipedal exercises, by progressing from concentric-eccentric to purely eccentric loading, by adding weight in a backpack (in steps of 5 kg when pain did not exceed 5 on a 0–10 numerical rating scale), and finally by using fast-rebounding and plyometric exercises</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and after 4 weeks of intervention. Method of measurement: Numerical pain rating scale (NPRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain, Quality of life. Timepoint: Before intervention and after 4 weeks of intervention. Method of measurement: Victorian Institute of Sport Assessment (VISA-A), The Achilles tendon Total Rupture Score (ATRS).</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-14</approval_date>
        <contact_name>Institutional review board</contact_name>
        <contact_address>1-km, Defence Road, Off Bhobatian Chowk , Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
