<?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>IRCT2017050233772N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-07</date_registration>
      <primary_sponsor>investigator</primary_sponsor>
      <public_title>Decreasing Ankle Swelling in Athletes</public_title>
      <acronym></acronym>
      <scientific_title>Difference between Neuromuscular Electrical Stimulation and Kinesio Taping® in Decreasing Ankle Swelling in Athletes with Lateral Ankle Sprain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>31</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25967</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ankle Sprain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: إased on the sheet by the person that a number written on it was (number 1 represents the electrical stimulation group and the number 2 represents the group Kinesiotape), the two treatment groups neuromuscular electrical stimulation (n = 18) and Kinesiotape (n = 17) groups. interventions were done during 5 days. Electrical stimulation of neuromuscular electrical stimulation device in the new company 710 P model comes with four electrodes were used. The interventions were as follows: one in the supine position to sleep and affected leg above heart level are high and on a seat placed using a rubber band tightly around the ankle it was connected. To minimize any movement of the ankle joint, the foot was placed against the wall. The type of electrode used in this study was Carbonflex disk with a thickness of 10 cm are made of carbon rubber and covered by a foam pad were not put directly on the skin. Two electrodes on muscle bulk  and two electrodes were placed on the tibialis anterior muscle. Feeling that the person will experience during the application process, he explained. Each of the two electrodes placed on the muscles targeted by a separate cable to two output devices was connected directly. Low-voltage electrical stimulation applied with rectangular waves (Rectangular waveform) with Modulation in frequency and duration of pulses were applied. Neuromuscular electrical stimulation test time by 30 minutes (360 cycles of 5 seconds) was determined. Each cycle of 400 pulses with different combinations of pulse period to the next pulse (Pulse-to-pulse intervals) and size it was time. The average frequency of 80 Hz electrical stimulation was calculated, but actually received electrical stimulation in Burst of short-term muscle contractions that cause for every 25/1 seconds (8.0 Hz) was. During each Burst, a pulse duration between 60 and 240 Myly¬Sanyh varied and ranged from pulse to pulse the next 8 ms (125 Hz), respectively. Intervention 2: Intervention group 2: Intervention in Kinesio taping (n=17) using tapes with a width of 5 cm Kinesio taping Tem Tex model and a thickness of 5 mm was carried out. High adhesion and is also waterproof with minimal skin irritation, the model was chosen because it was, because in this study Strips for 5 days on the body, and separating it from the skin during this time for researchers were important. kinesio taping applies for Fan cut the pattern. Days before the Kinesio taping person was asked to create maximum adhesion, to shave the hair area. For intervention, subjects were placed in the supine position and 13 cm above the ankle 10 cm high external and internal ankle injured ankle was checked. Another brigade that was on the inside of the ankle was cut to the size of the type.Kinesio taping both domestic and foreign bands marked the start of the leg and the foot metatarsal stress were 20 percent will continue. kinesiotape bar with four bars became thinner and each of them was placed a distance of about 1 cm from the adjacent bar. Kiesiotape bar slightly toward the inner surface of Tibia miles and sort order of the bands was as follows: the internal malleolus, on the inner ankle, ankle domestic front, and in line with the little finger.</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>pouya rabiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Karaj. moazen street</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3418 2365</telephone>
        <email>pouya_rabiei@yahoo.com</email>
        <affiliation>Islamic Azad University of Karaj</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>pouya rabiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Karaj. moazen street</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3418 2365</telephone>
        <email>pouya_rabiei@yahoo.com</email>
        <affiliation>Islamic Azad University of Karaj</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Diagnosis of lateral ankle sprain by the physician.&#13;
Exclusion criteria: fractures; open wounds; swelling systemic lower limbs due to heart disease, kidney or intravenous; skin's sensitivity to tape Kinesiotape; a piece of metal on foot; injured his ankle against the need to have surgery during the past year; taking blood pressure; and pacemakers.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>s93.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain and strain of ankle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: إased on the sheet by the person that a number written on it was (number 1 represents the electrical stimulation group and the number 2 represents the group Kinesiotape), the two treatment groups neuromuscular electrical stimulation (n = 18) and Kinesiotape (n = 17) groups. interventions were done during 5 days. Electrical stimulation of neuromuscular electrical stimulation device in the new company 710 P model comes with four electrodes were used. The interventions were as follows: one in the supine position to sleep and affected leg above heart level are high and on a seat placed using a rubber band tightly around the ankle it was connected. To minimize any movement of the ankle joint, the foot was placed against the wall. The type of electrode used in this study was Carbonflex disk with a thickness of 10 cm are made of carbon rubber and covered by a foam pad were not put directly on the skin. Two electrodes on muscle bulk  and two electrodes were placed on the tibialis anterior muscle. Feeling that the person will experience during the application process, he explained. Each of the two electrodes placed on the muscles targeted by a separate cable to two output devices was connected directly. Low-voltage electrical stimulation applied with rectangular waves (Rectangular waveform) with Modulation in frequency and duration of pulses were applied. Neuromuscular electrical stimulation test time by 30 minutes (360 cycles of 5 seconds) was determined. Each cycle of 400 pulses with different combinations of pulse period to the next pulse (Pulse-to-pulse intervals) and size it was time. The average frequency of 80 Hz electrical stimulation was calculated, but actually received electrical stimulation in Burst of short-term muscle contractions that cause for every 25/1 seconds (8.0 Hz) was. During each Burst, a pulse duration between 60 and 240 Myly¬Sanyh varied and ranged from pulse to pulse the next 8 ms (125 Hz), respectively.</i_keyword>
      <i_keyword>Intervention group 2: Intervention in Kinesio taping (n=17) using tapes with a width of 5 cm Kinesio taping Tem Tex model and a thickness of 5 mm was carried out. High adhesion and is also waterproof with minimal skin irritation, the model was chosen because it was, because in this study Strips for 5 days on the body, and separating it from the skin during this time for researchers were important. kinesio taping applies for Fan cut the pattern. Days before the Kinesio taping person was asked to create maximum adhesion, to shave the hair area. For intervention, subjects were placed in the supine position and 13 cm above the ankle 10 cm high external and internal ankle injured ankle was checked. Another brigade that was on the inside of the ankle was cut to the size of the type.Kinesio taping both domestic and foreign bands marked the start of the leg and the foot metatarsal stress were 20 percent will continue. kinesiotape bar with four bars became thinner and each of them was placed a distance of about 1 cm from the adjacent bar. Kiesiotape bar slightly toward the inner surface of Tibia miles and sort order of the bands was as follows: the internal malleolus, on the inner ankle, ankle domestic front, and in line with the little finger.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ankle Swelling. Timepoint: at baseline, after receiving the interventions, and 15 days following the treatment completion. Method of measurement: evaluate the extent of AS included volumetry, perimetry, relative volumetry, and the difference in both ankles.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>No secondery outcome measure. Timepoint: no secondery outcome measure. Method of measurement: no secondery outcome measure.</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>investigator</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-23</approval_date>
        <contact_name>Semnan University Medical Sciences And Health</contact_name>
        <contact_address>University Medical Sciences And Health, semnan semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
