<?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>IRCT20230418057955N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-06</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Active Release Technique And Positional Release Therapy For Tightened Calf Muscles.</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Effects Of Active Release Technique And Positional Release Therapy In Female Students With Tightened Calf Muscles.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random method was used. 
Individual randomization was assigned.
Table of random number of participants were generated.
Sealed envelopes were used in randomization.
The random sequence is typically built using algorithms that generate random numbers, Blinding description: Participants are unaware of their assigned groups (treatment/control) due to identical presentation of interventions.
In investigator-initiated trials, the PI is not involved in treatment allocation discussions with participants.
Care providers are blinded to participants' treatments, ensuring unbiased care delivery.
Those collecting data are uninformed about treatment allocation, maintaining objective data gathering.
 Data Safety and Monitoring Board's access to treatment information is limited, focusing on safety.
Writers use anonymized data, avoiding bias in result interpretation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tightness Of Calf Muscles.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: The group comprised of participants who received the experimental intervention under investigation. The intervention is designed to briefly describe the nature and purpose of the intervention. Participants in this group will be exposed to details of the intervention, such as treatment, therapy, medication, or any specific procedures. The objective of this intervention is explained the intended outcomes or goals. Intervention 2: Intervention group 2: The group comprised of participants who received the experimental intervention under investigation. The intervention is designed to briefly describe the nature and purpose of the intervention. Participants in this group will be exposed to details of the intervention, such as treatment, therapy, medication, or any specific procedures. The objective of this intervention is explained the intended outcomes or goals.</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  and secondary outcome both measure

When:
starting in January 2025

To whom:
Academicians

Conditions:
For Research purpose only

Where to obtain:
sibgahmaqsood547@gmail.com

How to obtain:
if any researcher share their ethical approval letter and summary of the ongoing research.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mariam Mehmood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sargodha Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 301 4223896</telephone>
        <email>mariam.mehmood@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sibgah Maqsood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gulshan-e-Hayat, ABC road Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 321 7838237</telephone>
        <email>sibgahmaqsood547@gmail.com</email>
        <affiliation>The University Of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects wearing high heels and willing to participate
Age 20-30 years
Reduced ROM (ankle dorsiflexion)
NPRS showing more than 3
Heels wearing duration: minimum 1 year
Wearing heels at least 5 times every week for 5 hours per day
Height of heel: 2” and above
Through flat palpation, one hypersensitive sore nodule within a perceptible tense band in the leg muscle</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lower limb musculoskeletal injury or surgery
Acute Cardio-Respiratory or Neurological disease
Medical or surgical complications
Fibromyalgia syndrome
Congenital deformity of the foot and ankle
Lower limb fracture
Diabetic neuropathy
Peripheral vascular disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.838</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other muscle spasm</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: The group comprised of participants who received the experimental intervention under investigation. The intervention is designed to briefly describe the nature and purpose of the intervention. Participants in this group will be exposed to details of the intervention, such as treatment, therapy, medication, or any specific procedures. The objective of this intervention is explained the intended outcomes or goals.</i_keyword>
      <i_keyword>Intervention group 2: The group comprised of participants who received the experimental intervention under investigation. The intervention is designed to briefly describe the nature and purpose of the intervention. Participants in this group will be exposed to details of the intervention, such as treatment, therapy, medication, or any specific procedures. The objective of this intervention is explained the intended outcomes or goals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention, 2nd week and 4th week after intervention. Method of measurement: Numerical Pain Rating Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ankle Range of Motion. Timepoint: before intervention, 2nd week and 4th week after intervention. Method of measurement: goniometer.</sec_outcome>
      <sec_outcome>Cadence. Timepoint: before intervention, 2nd week and 4th week after intervention. Method of measurement: stop watch.</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 Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-03</approval_date>
        <contact_name>institutional review committee board of ethics The university of Faisalabad</contact_name>
        <contact_address>Sheikhupura Road Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
