<?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>IRCT20210705051796N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-07</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Effects of static stretching with and without neurodynamics on range of motion, pain and functional ability</public_title>
      <acronym></acronym>
      <scientific_title>Effects of static stretching with and without neurodynamics on range of motion, pain and functional ability in females with hamstrings tightness</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57311</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Computer generated randomization assignment will be designed  by an independent statistician and randomization will be done by one of the research team members who will not be the part of any intervention, assessment or data analysis. Randomization assignments will be kept in opaque.  Outcome assessors will be unaware of group assignment. The intervention will be started on the day after randomization, for both group.For both groups the intervention will be continue for 5 consecutive days and reading should be taken before and after applying intervention  and followup will be done after one month , Blinding description: Participants, care provider , outcome assessor, data analyser and investigator will be unaware of intervention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Hamstrings Tightness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:Participants will receive neurodynamics along static stretching (NS-SS) of hamstring musculature. Subjects in lying supine and their neck and thoracic spine supported in a forward flexed position. Concurrent hip and knee flexion were alternated dynamically with concurrent hip and knee extension. The therapist alternated the combination of movement depending on the tissue resistance level. This combination of movements was performed for 180 seconds on their dominant lower extremity. This position will then maintained for 30 seconds consisted of six sets of 30 s with a 60 s rest between sets and repeated 5 times further on conservative days and then follow up after 1 month. Intervention 2: Intervention  group 2 : Participants will receive only static stretching (SS) of the hamstring muscles in their dominant leg. While subjects in lying supine, the dominant lower extremity would passively position into SLR position (hip in flexion, knee in extension and ankle in neutral) without pain/discomfort to the point where resistance to the movement will first noted. This position will then maintained for 30 seconds consisted of six sets of 30 s with a 60 s rest between sets and repeated 5 times further on conservative days and then follow up after 1 month. During the 30 second stretches, the therapist monitored the subject to ensure they did not make any compensation that could modify the stretching position. Each subject had a total of 180 seconds of stretching on their lower extremity.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nayab John</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km Raiwand Road,  The University of Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>50700</zip>
        <telephone>+92 42 111 865 865</telephone>
        <email>info@uol.edu.pk</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nayab John</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km Raiwand Road,  The University of Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>50700</zip>
        <telephone>+92 42 111 865 865</telephone>
        <email>info@uol.edu.pk</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female participants with hamstring tightness
Aging between 18 and 30 years
Participants with knee extension ≤ 20°</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Neurological disorders
Orthopedic diseases (Osteoarthritis, Rheumatoid Arthritis, Spondylolisthesis)
Hamstrings injury or strain
Chronic Low back pain
Any recent spinal surgery history</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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:Participants will receive neurodynamics along static stretching (NS-SS) of hamstring musculature. Subjects in lying supine and their neck and thoracic spine supported in a forward flexed position. Concurrent hip and knee flexion were alternated dynamically with concurrent hip and knee extension. The therapist alternated the combination of movement depending on the tissue resistance level. This combination of movements was performed for 180 seconds on their dominant lower extremity. This position will then maintained for 30 seconds consisted of six sets of 30 s with a 60 s rest between sets and repeated 5 times further on conservative days and then follow up after 1 month.</i_keyword>
      <i_keyword>Intervention  group 2 : Participants will receive only static stretching (SS) of the hamstring muscles in their dominant leg. While subjects in lying supine, the dominant lower extremity would passively position into SLR position (hip in flexion, knee in extension and ankle in neutral) without pain/discomfort to the point where resistance to the movement will first noted. This position will then maintained for 30 seconds consisted of six sets of 30 s with a 60 s rest between sets and repeated 5 times further on conservative days and then follow up after 1 month. During the 30 second stretches, the therapist monitored the subject to ensure they did not make any compensation that could modify the stretching position. Each subject had a total of 180 seconds of stretching on their lower extremity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion. Timepoint: Outcomes will be checked at baseline before apply intervention and after applying intervention on conservative  5 day and followup should be done after 1 month . Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Pain will be assess by using Visual analog scale . Before and after applying intervention for 5 consecutive days,and followup will be done after one month . Method of measurement: Numeric pain rating scale.</prim_outcome>
      <prim_outcome>Functional ability. Timepoint: Functional abilities will be measured on daily bases  .Base line reading  will be measured and then after applying intervention again the reading will be taken, this will be continue for 5 consecutive days (DAY 1, DAY 2 , DAY 3, DAY 4, DAY 5 )and after 1 month again the functional ability will be measured. Method of measurement: The Lower Extremity functional scale (LEFS).</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>Not Applicable</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-22</approval_date>
        <contact_name>Ethical Committee of The University of Lahore</contact_name>
        <contact_address>1 km Raiwand Road,  The University of Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-22</approval_date>
        <contact_name>Ethical Committee of The University of Lahore Institutional Review Board</contact_name>
        <contact_address>1 km Raiwand Road,  The University of Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
