<?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>IRCT20211018052799N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-01</date_registration>
      <primary_sponsor>Bu Ali Sina university ethics committee in research</primary_sponsor>
      <public_title>Effect of Neuromuscular and Neurofeedback Training on Chronic Ankle Instability</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Neuromuscular and Neurofeedback Training on Balance and Plantar Pressure Variables of Table Tennis Players with Chronic Ankle Instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59804</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: Participants were randomly divided into two groups of 15 people (neurofeedback and neuromuscular) and neuromuscular group using Random Number Generator software, Blinding description: In this study, both the examiner and the participants were blind. Because participants in both groups were performing neuromuscular exercises, as well as being unaware of the other group and the application of the protocol in the other group, they assumed that the main protocol was being applied to them. Also, the examiner was not aware of the existence of different interventions and which group each participant was in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic ankle instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Neuromuscular rehabilitation protocol was performed for 8 weeks 3 sessions per week for 30 minutes in each session. This training program, this exercises include One -legged knee flexion on three surfaces: flat, uneven surface and on balance boardToe stand with the help of the hand and without the help of the handOne-legged stand on three flat surfaces, uneven surface with eyes closed and on balance boardRunner’s pose on three flat surfaces, uneven surface with eyes closed and on balance boardCross-legged sway with the help of the hand, without the help of the hand, without the help of the hand with the eyes closed and on balance board and Toe walk. Intervention 2: Intervention group: The neurofeedback training was performed using an 8-channel ProComp Infiniti device (ProComp Infiniti Procomp2 thought technology co ltd. Canada) and the Biograpth infiniti version 5.0 software. Prior to training protocol, the neurofeedback specialist gave the patients a complete explanation of the components of the neurofeedback device and all the components that make this treatment method more effective. Prior to each training session, noise-causing devices or artifacts such as rings, belts, cell phones and bank cards were placed away from the training area. The treatment protocol of the present study was performed for 8 weeks, 3 sessions per week and each session for 30 minutes . The patient would sit comfortably on a chair to perform the training protocol. Neurofeedback specialist identified 10-20 O1 and O2 points based on the international system, then the area and earlobe were cleansed with medical alcohol and Nuprep exfoliating gel (Nuprep, Weaver, USA). Then, the active electrode on the O1 region and the reference electrode on the O2 region were glued by Ten20 conductive paste (Weaver, USA) and the ground electrode was placed on the right ear .</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data files measured by testers will be shared after the study if needed.

When:
Start the course one year after the publication of results and articles

To whom:
Researchers and researchers whose field of work is similar to the present research and are employed in universities

Conditions:
The data of the present study will be provided to other researchers only for comparison with future studies and the use of data and their analysis is not allowed.

Where to obtain:
Email adress m.azizian@phe.basu.ac.ir Phone number: 00989188157747

How to obtain:
A full description of the research should be provided and the details of the use of the data should be fully described.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Yalfani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۶۹۵-۶۵۱۷۸</zip>
        <telephone>0098 81 8265636</telephone>
        <email>ali_yalfani@yahoo.com</email>
        <affiliation>Bu Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Yalfani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan, Iran</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۶۹۵-۶۵۱۷۸</zip>
        <telephone>0098 81 8265636</telephone>
        <email>ali_yalfani@yahoo.com</email>
        <affiliation>Bu Ali Sina University of Hamadan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>One year before the present intervention, they suffered from lateral ankle sprain injury.Activity of the participants.
A score of 24 or higher on the Cumberland Questionnaire (Ankle Instability Assessment Tool)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>No surgery, fractures or serious injuries to the ankle and lower limbs.
No cardiovascular and respiratory diseases
No smoking
Lack of pes planus, pes cavus and hallux valgus
Absence of deformity in the thoracic, cervical, pelvic, lumbar and lower extremities
Lack of diabetes and diseases related to peripheral nerves
No history of using any type of shoe or medical shoe,
Do not use artificial limbs on the femur, knee and ankles</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other instability, ankle and foot</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: Intervention group: Neuromuscular rehabilitation protocol was performed for 8 weeks 3 sessions per week for 30 minutes in each session. This training program, this exercises include One -legged knee flexion on three surfaces: flat, uneven surface and on balance boardToe stand with the help of the hand and without the help of the handOne-legged stand on three flat surfaces, uneven surface with eyes closed and on balance boardRunner’s pose on three flat surfaces, uneven surface with eyes closed and on balance boardCross-legged sway with the help of the hand, without the help of the hand, without the help of the hand with the eyes closed and on balance board and Toe walk</i_keyword>
      <i_keyword>Intervention group: The neurofeedback training was performed using an 8-channel ProComp Infiniti device (ProComp Infiniti Procomp2 thought technology co ltd. Canada) and the Biograpth infiniti version 5.0 software. Prior to training protocol, the neurofeedback specialist gave the patients a complete explanation of the components of the neurofeedback device and all the components that make this treatment method more effective. Prior to each training session, noise-causing devices or artifacts such as rings, belts, cell phones and bank cards were placed away from the training area. The treatment protocol of the present study was performed for 8 weeks, 3 sessions per week and each session for 30 minutes . The patient would sit comfortably on a chair to perform the training protocol. Neurofeedback specialist identified 10-20 O1 and O2 points based on the international system, then the area and earlobe were cleansed with medical alcohol and Nuprep exfoliating gel (Nuprep, Weaver, USA). Then, the active electrode on the O1 region and the reference electrode on the O2 region were glued by Ten20 conductive paste (Weaver, USA) and the ground electrode was placed on the right ear .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Variables derived from floor pressure system data (pressure foot) - static balance - dynamic balance - Properioception. Timepoint: Pre test_ Post test. Method of measurement: Plantar pressure system data (pressure foot)_ Biodex balance system_ Electrogoniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life Questionnaire. Timepoint: Anxiety and Depression Questionnaire. Method of measurement: Questionnaire.</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>Bu Ali Sina university ethics committee in research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-13</approval_date>
        <contact_name>Research Ethics Committees of Bu Ali Sina University-Hamedan</contact_name>
        <contact_address>Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
