<?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>IRCT20210713051875N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Dry Needling on Human's Brain</public_title>
      <acronym></acronym>
      <scientific_title>The immediate Effect of Ankle Muscles Dry Needling on Brain 's Functions in healthy and ankle functional instability during functional task by Functional Magnetic Resonance Imaging.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66339</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the number of  healthy subjects in each group, the particular sort of intervention ( real or sham needle) is written on a piece of paper. Each paper is placed in a sealed envelope. One envelope will be chosen  randomly by the therapist at the beginning of the study session and the patient's intervention will be selected based on that. If any of the subjects is omitted from the study, one envelope related to the excluded subject's group will be replaced and they will be mixed again. Subjects with ankle impairment will receive real needling, Blinding description: At first, necessary explanation about the study and its aims will given to the participants. The explanation of the existence of two groups are given to the healthy subjects; Whereas no information about the difference interventions between two groups will be given to them. There will be no connection between subjects of each groups. This way they will be blind regarding intervention methods. In addition examination will be preformed by a physiotherapist who is not aware of the participant's group. So examiner is blind to the treatment method of each participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ankle functional instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Dry needling is performed by fast in fast out technique for the tibialis anterior and peroneus longous muscles. Intervention 2: Control group: The sham dry needling procedure is performed for one minute on the location of tibialis anterior and peroneus longous muscles.</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:
The raw data of research and its analysis will be available to the researcher if they request it.

When:
After the publication of articles resulting from the research.

To whom:
Researchers working in academic institution

Conditions:
The data are only available to other researchers to study and evaluate treatment outcomes.

Where to obtain:
Department of physiotherapy, School of Rehabilitation, Enghelab St; Professor Soofia Naghdi Email address: naghdi@sina.tums.ac.ir

How to obtain:
By sending an official E-mail to the corresponding author: professor Soofia Naghdi (naghdi@sina.tums.ac.ir) and request the data. The researcher will be answered as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roshanak Honarpisheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy department, School of Rehabilitation, Enghelab St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>009877520174</telephone>
        <email>rhonarpisheh@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roshanak Honarpisheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy department, School of Rehabilitation, Enghelab St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>009877520174</telephone>
        <email>rhonarpisheh@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy and right ankle sprain participants (18-40 years old)
Subjects do not participate in any sports or physical activities, based on Baecke questionnaire (8 score or less)
Contraindications of dry needling
Subjects with right ankle sprain should have following conditions:1- at least 2 history of ankle sprains that has disturbed the daily activities of the person for at least one day and the symptoms of inflammation, swelling, pain and redness have been seen 2-Ankle instability will be diagnosed by a self-administered questionnaire of Cumberland Ankle Instability Tool 3- feeling of instability or sudden giving way of the ankle ,at least twice during the last 6 months
Right domain leg</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any history of neurological and cardiovascular diseases
musculoskeletal disorder in other lower limb joints in ankle sprain subjects and any musculoskeletal disorder in lower limbs of the healthy participants
Any ankles' deformity
Any medical conditions including headache , … during study
Drug abuse or any medical use
Contraindications of MRI including any metal object in the body, pace maker and …
Drink caffeine couple of hours before brain scan</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.371</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other instability, right 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:  Dry needling is performed by fast in fast out technique for the tibialis anterior and peroneus longous muscles.</i_keyword>
      <i_keyword>Control group: The sham dry needling procedure is performed for one minute on the location of tibialis anterior and peroneus longous muscles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coordinates of maximum intensity; Voxel count; Peak intensity. Timepoint: During dorsiflexion movement (before dry needling intervention), during dry needling intervention, during dorsiflexion movement (after dry needling intervention). Method of measurement: Functional magnetic resonance imaging machine.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dorsi flexor strength. Timepoint: Before intervention, immediately after intervention. Method of measurement: Manual dynamometer.</sec_outcome>
      <sec_outcome>Active dorsi-flexor range of motion. Timepoint: Before intervention, immediately after intervention. Method of measurement: Standard goniometer.</sec_outcome>
      <sec_outcome>Pain. Timepoint: Before intervention, immediately after intervention. Method of measurement: Persian version of  McGill Pain Questionnaire Short-form.</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>2022-11-28</approval_date>
        <contact_name>Ethics committee OF Nursing and Midwifery &amp; Rehabilitation schools- Tehran university of Medical Sci</contact_name>
        <contact_address>Quds Ave, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
