<?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>IRCT20181001041197N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-03</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effect of Kinesio Taping on Dynamic Balance between Male and Female with unilateral Patellofemoral Pain Syndrome (PFPS)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Kinesio Taping on Dynamic Balance between Male and Female with unilateral Patellofemoral Pain Syndrome (PFPS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34410</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Participants are divided into two groups of women and men, and a homogeneous intervention (kinesio Tape) is applied to both, before and after tape, each group is evaluate, and then the two groups are compared.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patellofemoral pain syndrome.</hc_freetext>
      <i_freetext>Intervention group:  In both groups, men and women  undergo intervention. In both groups, the kinesio tape is applied onto the patella to correct the alignment.This research is done on two groups of women and men with patello femoral pain syndrome, aged 18 to 40 years. The sample size for each group is 19 people. Individuals are enrolled in the study through convenient sampling. After examining the criteria for entry and exit by the physiotherapist and completing the consent form and demographic form, the subjects are enrolled and the ability to maintain balance is examined through the Y balance test. To perform the Y test, the barefoot person stands in the center of the way and performs 6 times to avoid learning effects in each direction. Then rest for 5 minutes and again at the center of the Y-shaped marks with the affected foot and in each direction performs 3 times the test with a healthy foot. We calculate the maximum recorded distance in each direction and divide it by the length of the lower limb  and then multiply in 100 to achieve distance by percentage of foot length. This test is performed on the affected limb, in conditions with and without tape. Their balance is determined through the Y balance test before and after the intervention. Patients' pain intensity is determined by the Visual Analog Scale (VAS), in which the person is told to squat one leg up to a 45 degree angle and hold it for 10 seconds, and then they are asked to rate their pain. Line 10 cm. The zero number represents painless, and the number 10 represents the maximum amount of pain imaginable. People undergoing pain should have at least 3 upwards that are considered in the criteria for entry. The second stage of the test, after 5 minutes of rest, occurs at this stage, the person lying on the bed and limb Involved, with the aim of creating a medial glide, by kinesiotape, with a stretching of 50-75%. In this study, the Temtex TKT-012 kinesiology tape  is used. The efficiency of the taping technique is reduced by about 50% in the intensity of pain, after the patella taping compared to the previous one after a single leg squat test. Otherwise, the taping will be repeated again. Once again, the severity of pain is recorded by the visual analog scale (VAS) after the taping, and the Y balance test is also performed..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Javid Mostamand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jerib street., Isfahan University Medical Science; Faculty of Rehabilitation Sciences,</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745-164</zip>
        <telephone>+98 312600441</telephone>
        <email>zainab.hosseini62@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Javid Mostamand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jerib street; Isfahan University Medical Science; Faculty of Rehabilitation Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745-164</zip>
        <telephone>+98 312600441</telephone>
        <email>mostamand@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence anterior or retro patella Pain only in one leg
The report of pain at least in two of the functional activities throughout the day: squatting, running, climbing, kneeling and  prolonged sitting
The pain will be reported in the single leg squat test on the leg involved at 45 degree angle for 10 seconds
Score of at least 3 by the person himself on the  visual analog scale (VAS)
The McConnell test shows lateral glide
No received any rehabilitation treatment for knee joint for 3 months before entering the study.
Inactivity in certain sports
Gradual onset of pain for at least 8 weeks
Age between 18-40 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Traumatic, inflammatory and inflammatory lesions in the lower extremities
Dislocation and subluxation of the patella
History of surgery on the knees and the areas of the lower back, pelvis or lower extremities
Any signs of knee osteoarthritis in X-ray
The presence of fractures or deformities in the knees and lower extremities
135 degree knee limitation in sagittal plane
History of neurological, rheumatologic and musculoskeletal disorders in lower limbs
History of dizziness, uncorrected vision problems and internal ear disorders
Pain in the waist, pelvis and sacroiliac
The presence of lower limb dysfunction
Corticosteroid injections and receivied physiotherapy in the last 3 months and receivied opioid and analgesic drugs in the last 72 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chondromalacia patellae</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In both groups, men and women  undergo intervention. In both groups, the kinesio tape is applied onto the patella to correct the alignment.This research is done on two groups of women and men with patello femoral pain syndrome, aged 18 to 40 years. The sample size for each group is 19 people. Individuals are enrolled in the study through convenient sampling. After examining the criteria for entry and exit by the physiotherapist and completing the consent form and demographic form, the subjects are enrolled and the ability to maintain balance is examined through the Y balance test. To perform the Y test, the barefoot person stands in the center of the way and performs 6 times to avoid learning effects in each direction. Then rest for 5 minutes and again at the center of the Y-shaped marks with the affected foot and in each direction performs 3 times the test with a healthy foot. We calculate the maximum recorded distance in each direction and divide it by the length of the lower limb  and then multiply in 100 to achieve distance by percentage of foot length. This test is performed on the affected limb, in conditions with and without tape. Their balance is determined through the Y balance test before and after the intervention. Patients' pain intensity is determined by the Visual Analog Scale (VAS), in which the person is told to squat one leg up to a 45 degree angle and hold it for 10 seconds, and then they are asked to rate their pain. Line 10 cm. The zero number represents painless, and the number 10 represents the maximum amount of pain imaginable. People undergoing pain should have at least 3 upwards that are considered in the criteria for entry. The second stage of the test, after 5 minutes of rest, occurs at this stage, the person lying on the bed and limb Involved, with the aim of creating a medial glide, by kinesiotape, with a stretching of 50-75%. In this study, the Temtex TKT-012 kinesiology tape  is used. The efficiency of the taping technique is reduced by about 50% in the intensity of pain, after the patella taping compared to the previous one after a single leg squat test. Otherwise, the taping will be repeated again. Once again, the severity of pain is recorded by the visual analog scale (VAS) after the taping, and the Y balance test is also performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic balance. Timepoint: before and after intervention. Method of measurement: Y balance test.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-15</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Secretariat of the Ethics Committee, Room 209, Second Floor, Building No. 4, Isfahan University of Medical Sciences,Hezar Jerib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
