<?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>IRCT201109196767N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-10-12</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ankle muscle fatigue on postural control and muscular activation patterns</public_title>
      <acronym></acronym>
      <scientific_title>The effect of plantar flexor muscle fatigue on postural control and muscular activation pattern during external perturbation in healthy students (20-35 Y/O) of Shiraz Rehabilitation School</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7178</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Normal subjects.</hc_freetext>
      <i_freetext>Intervention 1: External perturbation (expected and unexpected): Subjects expose to a rapid loading in to the right palm (25% of body weight) from 20 cm obove his/har right palm, while the shoulder is in 90 flexion. In expected condition the subjects are aware of loading time (3 seconds after the beep sound the loading will occure). But in unexpected condition the subjects do not any thing about the loading time. Intervention 2: Making  the plantar flexor muscles fatigued: The person sitting on the bed with the thigh and leg on the it. One end of the load cell strap will be fixed to the bar behind the person and the other end will be fixed below the ankles. The maximum voluntary contraction of both flexor muscles will be evaluated using the electrical load cell. Then,  60 percent of this amount is applied to fatigue the muscles; The person will asked to apply pressure to the strap while maintain 60 percent of his/her maximum voluntary contraction by looking at the bar scale on the monitor until feel fatigue. When the bar scale is in green territory the person would maintain the contraction. But if it is in red territory and last for 5 seconds it assumes as fatigue.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Zahra Rojhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First Abiverdi, Chamran Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1627 1551</telephone>
        <email>rojhaniz@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Zahra Rojhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First Abiverdi, Chamran Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1626 5108</telephone>
        <email>rojhaniz@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Healthy students aged 20-35 years old&#13;
Exclusion criteria: Any deviation in the lower extremities and spine alignment;&#13;
History of pain and trauma to the lower extremities and trunk in the past six months; Musculoskeletal and neuromuscular disorders; History of diseases that involve vestibular system, eyes, central nervous system and peripheral nervous system; Inner ear disease; History of surgery in the lower extremities and trunk;&#13;
History of back pain in past 6 months; Doing regular exercise at least 3 times a week for 30-45 minutes</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Diagnosis</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>External perturbation (expected and unexpected): Subjects expose to a rapid loading in to the right palm (25% of body weight) from 20 cm obove his/har right palm, while the shoulder is in 90 flexion. In expected condition the subjects are aware of loading time (3 seconds after the beep sound the loading will occure). But in unexpected condition the subjects do not any thing about the loading time.</i_keyword>
      <i_keyword>Making  the plantar flexor muscles fatigued: The person sitting on the bed with the thigh and leg on the it. One end of the load cell strap will be fixed to the bar behind the person and the other end will be fixed below the ankles. The maximum voluntary contraction of both flexor muscles will be evaluated using the electrical load cell. Then,  60 percent of this amount is applied to fatigue the muscles; The person will asked to apply pressure to the strap while maintain 60 percent of his/her maximum voluntary contraction by looking at the bar scale on the monitor until feel fatigue. When the bar scale is in green territory the person would maintain the contraction. But if it is in red territory and last for 5 seconds it assumes as fatigue</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bilateral transverse abdominals muscle activation. Timepoint: Before and after expected and unexpected sudden hand loading (before and after plantar flexor muscle fatigue). Method of measurement: Telemetry EMG (Mega electronics Ltd.Finland).</prim_outcome>
      <prim_outcome>Bilateral semitendinosus muscle activation. Timepoint: Before and after expected and un expected sudden hand loading (before and after plantar muscle fatigue). Method of measurement: Telemetry EMG (Mega electronics Ltd.Finland).</prim_outcome>
      <prim_outcome>Center of pressure displacement. Timepoint: Before and after expected and unexpected sudden hand loading (before and after plantar flexor muscle fatigue). Method of measurement: Kistler force plate (9286AA,Sweden).</prim_outcome>
      <prim_outcome>Center of pressure velocity. Timepoint: Before and after expected and unexpected sudden hand loading (before after plantar flexor muscle fatigue). Method of measurement: Kistler force plate (9286AA,Sweden).</prim_outcome>
      <prim_outcome>Bilateral erector spinae muscle activation. Timepoint: Before and after expected and unexpected sudden hand loading (before and after plantar flexor muscle fatigue). Method of measurement: Telemetry EMG (Mega electronics Ltd.Finland).</prim_outcome>
      <prim_outcome>Bilateral soleus muscle activation. Timepoint: Before and after expected and unexpected sudden hand loading (before and after plantar flexor muscle fatigue). Method of measurement: Telemetry EMG (Mega electronics Ltd.Finland).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-15</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Ave Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
