<?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>IRCT20210505051181N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-13</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing passive and active stretching techniques on iliotibial band</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the immediate effect of active stretching versus self-myofascial release on iliotibial band flexibility and functional activity in semi elite athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56087</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the limited randomization method of block randomization will be used. Blockage is usually used to balance the number of samples allocated to each of the studied groups. The size of all the blocks is equal and in this trial which includes 51 patients in three groups, we will have blocks with size of 6. Random allocation software is also used for randomization. In order to conceal allocation of participants to the groups, sequentially numbered, sealed, opaque envelopes (SNOSE) will be used, Blinding description: This study is single blind and the stages of evaluation and treatment are performed by two different physiotherapists and the evaluator is blind to the type of interventions performed and thus bias is prevented.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Iliotibial band syndrome.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: People using the hard model foam roller with dimensions of 60 by 15 cm by Behsazan Modern Company in one session. After learning how to use the foam roller, how to position during use and also the duration of using the foam roller to the participants, people are asked to lie on their side, then place the foam roller at the highest junction of the iliotibial band structures, slightly below the iliac crest. Individuals are asked to roll the foam roller towards the distal end of the iliotibial band junction at a constant speed and slowly by moving the body. The average speed of moving the foam roller is 5 movements per 30 seconds on average, and this speed is the same and constant in all people. Individuals are asked to do this slowly for three minutes. Intervention 2: Second intervention group: People using Proprioceptive Neuromuscular Facilitation (PNF) stretching technique for 3 to 5 minutes in three steps. In the first step, the therapist gently moves the patient's limb from the hip joint to the end of the range of extension, adduction, and external rotation so that the iliotibial band at the end of the range is stretched. In the second stage, the patient is then asked to apply force in the direction of flexion, abduction and internal rotation by pressing his/her foot on the therapist's hand for 5 to 8 seconds. In the third step, the patient is then asked to relax his/her muscles again, and this time the therapist gently moves the patient's limbs to a new range of extension, adduction, and external rotation of the hip joint, and maintains traction by reaching the end of the range. These steps continue until there is no further increase in range of motion. Intervention 3: Third intervention group: Combination therapy group of foam roller and proprioceptive neuromuscular facilitation (PNF) stretching techniques.</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:
Data can be shared after making participants unrecognizable.

When:
Start access period 6 months after the results publication

To whom:
Any researchers will have access to the data after allowance of corresponding author.

Conditions:
Performing any analysis to any data resulted form this study will be allowed only with the permission of corresponding author.

Where to obtain:
Email the researcher, Ehsan Afshari
pt.Afshari@yahoo.com

How to obtain:
Email the researcher - Request from the Vice Chancellor for Research - Provide information to the applicant

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Afshari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8, Fourth Floor, Arshia Apartment, Hasht Alley, Abrishami St.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7144816874</zip>
        <telephone>+98 71 3227 4068</telephone>
        <email>pt.Afshari@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrnaz Kajbafvala</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Shahid Dastgerdi (Zafar) Ave, Aliasghar Children Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2304 6688</telephone>
        <email>kajbafvala.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>20 to 40 years old semi-professional athletes
Confirmation of unilateral or bilateral length reduction in iliotibial band by using modified Ober test</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having iliotibial band syndrome with pain or limping  symptoms
Surgery history in the last 3 months in each of the musculoskeletal structures of the lower limbs and pelvic girdle
People who have had lower limb surgery more than twice
Rheumatic patients
Existence of structural or postural disorders such as severe kyphosis or scoliosis in the individual
Having neurological disorders
Structural disorders in pelvis and lower limbs
Pregnancy
History of lower limb fracture or trauma in the last year</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iliotibial band syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: People using the hard model foam roller with dimensions of 60 by 15 cm by Behsazan Modern Company in one session. After learning how to use the foam roller, how to position during use and also the duration of using the foam roller to the participants, people are asked to lie on their side, then place the foam roller at the highest junction of the iliotibial band structures, slightly below the iliac crest. Individuals are asked to roll the foam roller towards the distal end of the iliotibial band junction at a constant speed and slowly by moving the body. The average speed of moving the foam roller is 5 movements per 30 seconds on average, and this speed is the same and constant in all people. Individuals are asked to do this slowly for three minutes.</i_keyword>
      <i_keyword>Second intervention group: People using Proprioceptive Neuromuscular Facilitation (PNF) stretching technique for 3 to 5 minutes in three steps. In the first step, the therapist gently moves the patient's limb from the hip joint to the end of the range of extension, adduction, and external rotation so that the iliotibial band at the end of the range is stretched. In the second stage, the patient is then asked to apply force in the direction of flexion, abduction and internal rotation by pressing his/her foot on the therapist's hand for 5 to 8 seconds. In the third step, the patient is then asked to relax his/her muscles again, and this time the therapist gently moves the patient's limbs to a new range of extension, adduction, and external rotation of the hip joint, and maintains traction by reaching the end of the range. These steps continue until there is no further increase in range of motion.</i_keyword>
      <i_keyword>Third intervention group: Combination therapy group of foam roller and proprioceptive neuromuscular facilitation (PNF) stretching techniques</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion of hip joint adduction. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Electro goniometer and inclinometer.</prim_outcome>
      <prim_outcome>Iliotibial band flexibility. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Movement assessment by using single leg hop test. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Tape meter.</sec_outcome>
      <sec_outcome>Movement assessment by using vertical jump test. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Tape meter.</sec_outcome>
      <sec_outcome>Movement assessment by using lateral hop test. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Tape meter.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-11</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No. 8, Fourth Floor, Arshia Apartment, Eight Alley, Shiraz Abrishami St. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
