<?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>IRCT20171111037388N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Dry Needling on Spasticity</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Dry Needling on Upper and Lower Dysfunction on stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36798</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the random number table, patients are placed in one of two groups, Blinding description: Patients are not aware of being in the intervention group or the control group. The control group will receive the intervention once the study finished. In addition, both group participate in their conventional therapies. Measurements are performed by an assessor who does not know the training protocols that each group has done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Brain Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A specialist who has expertise in dry needling, will deliver three sessions of dry needling on the spastic muscles of the upper and lower extremities on the hemiplegic side with a 48 hours interval between sessions. At baseline, immediately after last session of dry needling and after 1 month of baseline, the blind assessor, expert physiotherapist, will perform the clinical tests. Intervention 2: Control group: A specialist who has expertise in dry needling, will deliver three sessions of placebo dry needling on the spastic muscles of the upper and lower extremities on the hemiplegic side with a 48 hours interval between sessions.At baseline, immediately after last session of placebo dry needling and after 1 month of baseline, the blind assessor, expert physiotherapist, will perform the clinical tests.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ardalan Shariat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>alale ale ahmad, Sports Medicine Research Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14395-578</zip>
        <telephone>+98 939 861 4772</telephone>
        <email>ardalansh2002@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ardalan Shariat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sports Medicine research center, jalale ale ahmad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14395-578</zip>
        <telephone>+98 939 861 4772</telephone>
        <email>ardalansh2002@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>first brain stroke
Sufficient communication skills to show yes / no verbally or through gestures
be able to walk for at least 10 meter
MMAS score equal or more than one
unilateral hemiparesis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>unable patients to follow the instructions
severe musculoskeletal disorders (For example, severe osteoporosis, arthritis}
psychiatric disorders requiring drug therapy
cognitive disorders
contraindication to dry needling
using anti-spastic drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>164</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stroke, not specified as hemorrhage or infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A specialist who has expertise in dry needling, will deliver three sessions of dry needling on the spastic muscles of the upper and lower extremities on the hemiplegic side with a 48 hours interval between sessions. At baseline, immediately after last session of dry needling and after 1 month of baseline, the blind assessor, expert physiotherapist, will perform the clinical tests.</i_keyword>
      <i_keyword>Control group: A specialist who has expertise in dry needling, will deliver three sessions of placebo dry needling on the spastic muscles of the upper and lower extremities on the hemiplegic side with a 48 hours interval between sessions.At baseline, immediately after last session of placebo dry needling and after 1 month of baseline, the blind assessor, expert physiotherapist, will perform the clinical tests.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Walking speed. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: 10 meter walking test.</prim_outcome>
      <prim_outcome>Spasticity. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: modified modified ashworth scale.</prim_outcome>
      <prim_outcome>Mobility. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: Timed up and go test.</prim_outcome>
      <prim_outcome>Hand dexterity. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: Box and Block test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: Single Leg Stance Test.</sec_outcome>
      <sec_outcome>Daily living activity. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: Barthel index.</sec_outcome>
      <sec_outcome>Range of motion. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: goniometer.</sec_outcome>
      <sec_outcome>Pennation angle of gastrocnemius muscle. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: sonography.</sec_outcome>
      <sec_outcome>Gastrocnemius muscle thickness. Timepoint: Baseline, immediately after treatment and after 4 weeks. Method of measurement: sonography.</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>2019-01-05</approval_date>
        <contact_name>committee Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No 7, Al-e-Ahmad Highway, Tehran, IR Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
