<?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>IRCT20150131020888N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-11</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences, Vice Chancellory of Research and Technology</primary_sponsor>
      <public_title>The Effects of Facilitatory Kinesiotaping of Gastrocnemius on Dynamic Balance in Healthy Nonathelete Middle-age Men</public_title>
      <acronym></acronym>
      <scientific_title>The Immediate and Short-term Effects of Facilitatory Kinesiotaping of Gastrocnemius on Electrical Activity of the Muscle and Dynamic Balance in Healthy Nonathelete Middle-age Men (Double Blinded Randomized Control Trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18446</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization using coin. a blind person throw the coin. if the one group samples were allocated before the other, the remaining subjects will be allocated to the second group, Blinding description: 1. Participants are blind to the optimal kinesiotaping method
2. The one who put the tapes on participants' calf is blind to the study design and intervention plan
3. The outcome assessor can not see the tape in subjects' calf since every subject will wear a calf cover 
4. the analyzer knows the study groups as 1 and 2 and has no clue that which group is the true kinesiotaping group.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: electromyography. Condition 2: balance.</hc_freetext>
      <i_freetext>Intervention 1: Control (Sham) Group: this group will have sham kinesiotaping on origin and insertion of Gastrocnemius muscle of the dominant leg just as the anchor and end section of KT in intervention group. Sham KT will be from the same KT brand and will  be applied b. Intervention 2: Intervention Group: this group will have facilitatory kinesiotaping from origin to insertion of Gastrocnemius muscle of the dominant leg. the subject lies in prone, the ''I'' strap proposed by kase et al with no tension on the anchor, by 15-35% stretch in.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zahra Sadat Rezaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib Ave. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745-164</zip>
        <telephone>00983137925012; 00983137925042</telephone>
        <email>zrezaeian@yahoo.com</email>
        <affiliation>Electrophysiology Research Center, Department of Physical therapy, Faculty of Rehabilitation Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zahra Sadat Rezaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib Ave. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745-164</zip>
        <telephone>00983137925012; 00983137925042</telephone>
        <email>zrezaeian@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men
Being Healthy
Middle-age (40-65 years)
Nonathelete</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>any known musculoskeletal, cardiovascular and chronic problems require medication;
any neurological, vestibular, visual and hearing problems;
arthritis or other joint-related problems during the past 12 months;
previous allergies to adhesive tapes; previous Use of kinesiotape or knowledge about the effects it;
regular exercise activities during the six months prior to the study and during the study;
pain in lumbar and lower extremities during the selection process and inability to perform the test</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control (Sham) Group: this group will have sham kinesiotaping on origin and insertion of Gastrocnemius muscle of the dominant leg just as the anchor and end section of KT in intervention group. Sham KT will be from the same KT brand and will  be applied b</i_keyword>
      <i_keyword>Intervention Group: this group will have facilitatory kinesiotaping from origin to insertion of Gastrocnemius muscle of the dominant leg. the subject lies in prone, the ''I'' strap proposed by kase et al with no tension on the anchor, by 15-35% stretch in</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Electerical Muscle Activity. Timepoint: Before, Immediately, 20 Minutes and 24 Hours after Kinesiotaping, Immediately after tape removal. Method of measurement: Surface Electeromyography.</prim_outcome>
      <prim_outcome>Dynamic Balance. Timepoint: Before, Immediately, 20 Minutes and 24 Hours after Kinesiotaping, Immediately after tape remova. Method of measurement: strip meter.</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, Vice Chancellory of Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-05</approval_date>
        <contact_name>Isfahan University of Medical Sciences, Ethics Committee</contact_name>
        <contact_address>Hezar Jarib Aven. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
