<?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>IRCT20090301001722N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effect of Virtual Reality training and conventional training in athletes with Functional Ankle Instability</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Virtual reality and conventional training on functional ability and neurocognitive function in athletes with Functional Ankle Instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1220</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the matched pairs design athletes were pair-matched in terms of age, height, weight, duration of physical activity, and lower-limb dominance and then randomly assigned (block randomization) in two equal experimental and control groups using the Random Allocation Software, Blinding description: All tests are conducting by a physiotherapist who is blind to the assignment and type of training of athletes that perform by the second physiotherapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Functional ankle instability.</hc_freetext>
      <i_freetext>Intervention 1: In the experimental group, athletes have performed Wii Fit Plus games including balance training games (e.g. Soccer heading, Ski slalom, Tight rope walk, Table tilt), and strengthening exercises (e.g. Single leg extension, Sideways leg lift, Single leg twist, Rowing squat). In balance training games the athlete stands on the Wii balance board and maintains his balance by shifting his weight during the games. In strengthening games, the athlete stands on the board, and in each game during the specific movements, he must limit the gravity point movements to earn more points. Intervention 2: In the control group, athletes have performed conventional exercises including plantar flexion, dorsiflexion, inversion, and eversion movements with Thera-Band and exercising with the balance board. Training with Thera-Band is performed in three sets with ten repetitions for each movement and is performed in the first, second, third, and fourth weeks, with red, green, blue, and black, respectively. To determine Thera-Band resistance during the ankle movements, 70% of leg length is considered as Thera-Band length, for each athlete. The athletes stand on the balance board and move the front edge against the floor then move the board back, in the first week. During exercise, the board should not touch the floor. In the second week, they move the left and right edges against the floor, and in the last two weeks, circular movements are performed. (they continue the movement for 15 seconds; rest for 10 seconds; repeat this trend 10 times).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Avenue, after Pich-E-Shemiran, next to SafiAlishah St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 26 3351 9765</telephone>
        <email>rafoolin2007@gmail.com</email>
        <affiliation>School of Rehabilitation, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohammad-Reza  Hadian Rasanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Avenue, Next to Safialishah</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11489651111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>hadianrasan@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male athletes are 19-25 years old
They have at least one significant unilateral inversion sprain of either ankle followed by more than one repeated injury or the perception of the ankle “giving-way,” within the last year
No evidence of mechanical instability; that assessed by the anterior drawer and talar tilt tests
No history of ankle injury within the 3 months before participation
No ankle surgery, no vestibular or respiratory disorder, no cognitive deficit (A score of 23 or less in Mini-Mental State Examination), no diabetes or recent lower-limb or low back pathology
A Cumberland Ankle Instability Tool score lower than 24
Not participating in other rehabilitation exercise programs</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Report any pain
Reluctant to continue the tests
Use any medication with possible effects on neurocognitive function or functional ability</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain 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>In the experimental group, athletes have performed Wii Fit Plus games including balance training games (e.g. Soccer heading, Ski slalom, Tight rope walk, Table tilt), and strengthening exercises (e.g. Single leg extension, Sideways leg lift, Single leg twist, Rowing squat). In balance training games the athlete stands on the Wii balance board and maintains his balance by shifting his weight during the games. In strengthening games, the athlete stands on the board, and in each game during the specific movements, he must limit the gravity point movements to earn more points.</i_keyword>
      <i_keyword>In the control group, athletes have performed conventional exercises including plantar flexion, dorsiflexion, inversion, and eversion movements with Thera-Band and exercising with the balance board. Training with Thera-Band is performed in three sets with ten repetitions for each movement and is performed in the first, second, third, and fourth weeks, with red, green, blue, and black, respectively. To determine Thera-Band resistance during the ankle movements, 70% of leg length is considered as Thera-Band length, for each athlete. The athletes stand on the balance board and move the front edge against the floor then move the board back, in the first week. During exercise, the board should not touch the floor. In the second week, they move the left and right edges against the floor, and in the last two weeks, circular movements are performed. (they continue the movement for 15 seconds; rest for 10 seconds; repeat this trend 10 times).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neurocognitive reaction time. Timepoint: Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention. Method of measurement: Measurement tool: DLRT software, Measurement scale: milliseconds.</prim_outcome>
      <prim_outcome>Number of errors in neurocognitive test. Timepoint: Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention. Method of measurement: Measurement tool: DLRT software, Measurement scale: Number.</prim_outcome>
      <prim_outcome>Reach distance in SEBT. Timepoint: Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention. Method of measurement: Measurement tool: Meter, Measurement scale: Meter.</prim_outcome>
      <prim_outcome>Jump distance in single hop test. Timepoint: Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention. Method of measurement: Measurement tool: Meter, Measurement scale: Meter.</prim_outcome>
      <prim_outcome>The elapsed time to perform the 8-hop and side hop tests. Timepoint: Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention. Method of measurement: Measurement tool: Stopwatch, Measurement scale: milliseconds.</prim_outcome>
      <prim_outcome>Subjective-sense of instability. Timepoint: Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention. Method of measurement: Cumberland Ankle Instability Tool score (CAIT).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-19</approval_date>
        <contact_name>Ethics Committee of School of Rehabilitation, Tehran University of Medical Science</contact_name>
        <contact_address>School of Rehabilitation, Piche Shemiran, Enghelab Ave, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
