<?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>IRCT20240721062499N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-03</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Primal reflex release technique for calf tightness</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of primal reflex release technique versus positional release technique on tightened calf muscles</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78142</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization clinical trial was conducted by using stratified randomization.
Unit of randomization were individuals. The tools used in randomization were random numbers. Random sequence was done by selecting the individuals one by one as they met the criteria of inclusion. Allocation concealment was carried out, Blinding description: The participants were blinded in the study. The researcher did not inform the participant that in which intervention group they have been added.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Calf tightness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 or group A was provided with primal reflex release technique and hot pack as baseline treatment. Two sessions were done during a week and duration of each session was of 15 minutes. In a single session 3 sets of the technique was given with each set of 10-15 seconds and hot pack for 10 minutes. The procedure of the technique is as follows; With knee flexed at 90 degrees ask patient to dorsiflex ankle while keeping toes flexed. Now apply strokes on anterior tibialis tendon while patient holds ankle in dorsiflexion against resistance. Intervention 2: In intervention group 2 or group B, participants received positional release technique (3 sets in which each set was of 90 seconds) for calf tightness and hot pack (10 minutes) as baseline treatment. Total time for each session was 15 minutes. For gastrocnemius the subject in prone position and ankle in plantar flexion and knee in 90-degree flexion. For 90 seconds, the therapist applies intense pressure to palpable taut band for 3 times.</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:
Comparative effects of primal reflex release technique versus positional release technique on tightened calf muscles / results for primary outcome measures

When:
starting of October 2024

To whom:
people working in academic institutions

Conditions:
medical students, teachers

Where to obtain:
2022-ms-pt-023@tuf.edu.pk

How to obtain:
2022-ms-pt-023@tuf.edu.pk

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rubeena Zulfiqar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Town, West Canal Road, Faisalabad, Punjab</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8868326</telephone>
        <email>asst.prof.rehab.446@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rubeena Zulfiqar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Town, West Canal Road, Faisalabad, Punjab</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8868326</telephone>
        <email>asst.prof.rehab.446@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult Age 20 to 30 years
Both gender (Male, Female)
Prolong standing for more than six hours from more than two months.
Reduced ROM (ankle dorsiflexion&lt;15).
Tender nodules or tender points in calf muscles on deep palpation.
NPRS showing more than 3(3-10).</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lower limb surgery (six months).
Medical or surgical complication e.g infection, necrosis, ulcer.
Fibromyalgia.
Congenital foot and ankle deformity e.g club foot, cleft foot, pes cavus.
Lower limb fracture.
Deep vein thrombosis both acute and chronic.
Diabetic neuropathy.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.606</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in leg, unspecified</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 or group A was provided with primal reflex release technique and hot pack as baseline treatment. Two sessions were done during a week and duration of each session was of 15 minutes. In a single session 3 sets of the technique was given with each set of 10-15 seconds and hot pack for 10 minutes. The procedure of the technique is as follows; With knee flexed at 90 degrees ask patient to dorsiflex ankle while keeping toes flexed. Now apply strokes on anterior tibialis tendon while patient holds ankle in dorsiflexion against resistance.</i_keyword>
      <i_keyword>In intervention group 2 or group B, participants received positional release technique (3 sets in which each set was of 90 seconds) for calf tightness and hot pack (10 minutes) as baseline treatment. Total time for each session was 15 minutes. For gastrocnemius the subject in prone position and ankle in plantar flexion and knee in 90-degree flexion. For 90 seconds, the therapist applies intense pressure to palpable taut band for 3 times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and after 4 weeks after intervention. Method of measurement: NPRS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Goniometer.</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>2024-01-05</approval_date>
        <contact_name>Research and Ethics / technical committee for The University of Faisalabad</contact_name>
        <contact_address>Faisal Town, West Canal Road, Faisalabad, Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
