<?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>IRCT20230123057192N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of dry needling as a physiotherapy approach on brain activities and spasticity of patients after stroke.</public_title>
      <acronym></acronym>
      <scientific_title>A comparison on the effects of a single session of brachialis and Flexor Carpi Radialis muscles' dry needling on spasticity and  brain activities of patients after stroke based on fMRI findings.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68282</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, both groups will be treated by dry needling, with the difference that the intervention for one group is for the brachialis muscle (as the proximal muscle) and in the other group for the flexor carpi radialis muscle (as the distal muscle).In this case, we have active control group, it means that each group receiving the intervention should be considered as a control for the other group, Randomization description: Concealed allocation by using a computer-generated randomised table of numbers created before data collection and then delivery of the secret sealed envelopes which include numbered cards. The therapist opens the envelope and performs the treatment according to the specified group, Blinding description: f-MRI unit expert as the first evaluator (collector of brain activity variable data) and also a physiotherapist as the second evaluator (collector of other variable data) in this research are blind to the treatment groups . In this way, both people only collect the data presented by the main researcher without knowing about the treatment and the related treatment group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke, Hemiplegia, spasticity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Deep fast in and fast out method of dry needling in the brachialis muscle for 1 minute. Intervention 2: Intervention group: Deep fast in and fast out method of dry needling in the flexor carpi radialis muscle for 1 minute.</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 researchers if they request it.

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

To whom:
Researchers working in academic institutions.

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

Where to obtain:
Dr. Noureddin Nakhostin Ansari, Department of Physiotherapy, School of Rehabilitation,Tehran University of Medical Sciences, Enghelab Ave., Piche-e-shemiran, 09122979309, nakhostin@sina.tums.ac.ir

How to obtain:
By sending an official E-mail to the corresponding author, professor Noureddin Nakhostin Ansari(nakhostin@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>Mahdi Seyfollahipoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.19, Jahad alley , Shariati Ave , Abbas abad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1558748611</zip>
        <telephone>+98 21 8612 1931</telephone>
        <email>m-seyfollahipoor@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Noureddin Nakhostin Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation,Tehran University of Medical Sciences, Enghelab Ave., Piche-e-shemiran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>nakhostin@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First ever stroke resulted in hemiplegia
Age between 40 to 65 years
MMAS Score of spasticity in related muscles should be at least 1</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous treatment with nerve blocks, motor point injection with neurolytic agents for spasticity at any time, or with BTX-A in the 6 months preceding the study
Existence of severe Cognitive and perceptual deficits
History of dry needling in the past 6 months
Contraindications to dry needling
Cervical radiculopathy
Contracture of related muscles
Unwilling to take part in the study
Contraindications to MRI</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G81.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spastic hemiplegia</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: Deep fast in and fast out method of dry needling in the brachialis muscle for 1 minute.</i_keyword>
      <i_keyword>Intervention group: Deep fast in and fast out method of dry needling in the flexor carpi radialis muscle for 1 minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of spasticity of the brachialis and flexor carpi radialis muscles, which is measured based on the MMAS test. Timepoint: Before, immediately after and 30 minutes after the intervention. Method of measurement: Through the MMAS test by a physiotherapist who is expert in patients with hemiplegia.</prim_outcome>
      <prim_outcome>Severity of brain activity. Timepoint: Before, immediately after and 30 minutes after the intervention. Method of measurement: Analysis of fMRI findings after finger tapping.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Active/passive elbow and wrist range of motions. Timepoint: Before, immediately after and 30 minutes after the intervention. Method of measurement: Through a goniometer and by a physiotherapist familiar with the desired assessment.</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>2023-01-18</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation - Tehran University o</contact_name>
        <contact_address>Central Organization of Tehran University of Medical Sciences, corner of Qods St.,  Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
