<?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>IRCT20210713051875N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dry needle techniques in the treatment of upper limb patients with stroke</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two methods of dry needling application on spasticity, range of motion and upper limb function in patients with chronic stroke: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57486</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the number of  patients in each group, the particular sort of treatment ( fast in fast out or rotational manipulation techniques) 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 first session of the patient treatment and the patient's treatment technique is selected based on that. If any of the patients is omitted from the study, one envelope related to the excluded patient treatment group will be replaced  and they will be mixed again, Blinding description: At first, necessary explanation about the study, the aims and the existence of two groups are given to the patients; Whereas no information about the difference methods of treatments between two groups will be given to them. There will be no connection between patients of each groups. This way patients are blind regarding treatments methods. In addition examination will be preformed by a physiotherapist who is not aware of the treatment group. So examiner is blind to the treatment method of each participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dry needling is performed by fast in fast out technique for the wrist flexor muscles, including the flexor carpi radialis and the  flexor carpi ulnaris. Each needle is applied for one minute. The number of treatment sessions will be three sessions during a week. Intervention 2: Intervention group: Dry needling is used with the rotation technique on the flexor muscles of the wrist, including the flexor carpi radialis and flexor carpi ulnaris. The needle stays in this position for ten minutes and after five minutes the twist is extended again. The number of treatment sessions will be three sessions during a week.</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>Department of physiotherapy, School of Rehabilitation, Enghelab St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 0174</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>+98 21 7752 0174</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>first-ever stroke resulted in hemiplegia
disease duration of at least 6 months
wrist flexor modified modified Ashworth Scale (MMAS) spasticity score ≥1
No limitation in passive range of motion of the effected wrist</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any cognitive problems in the patient
Diabetes or neurological pain
Wrist contracture
Dry needling contraindication
Taking anti-Spastic drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Brain stem stroke syndrome</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 wrist flexor muscles, including the flexor carpi radialis and the  flexor carpi ulnaris. Each needle is applied for one minute. The number of treatment sessions will be three sessions during a week.</i_keyword>
      <i_keyword>Intervention group: Dry needling is used with the rotation technique on the flexor muscles of the wrist, including the flexor carpi radialis and flexor carpi ulnaris. The needle stays in this position for ten minutes and after five minutes the twist is extended again. The number of treatment sessions will be three sessions during a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spasticity. Timepoint: Before intervention, immediately after intervention, one week after intervention. Method of measurement: Modified Modified Ashworth.</prim_outcome>
      <prim_outcome>Function. Timepoint: Before intervention, immediately after intervention, one week after intervention. Method of measurement: Fugle-Meyer assessment upper extremity scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Active wrist range of motion. Timepoint: Before intervention, immediately after intervention, one week after intervention. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Passive wrist range of motion. Timepoint: Before intervention, immediately after intervention, one week after intervention. Method of measurement: Goniometer.</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>2021-06-30</approval_date>
        <contact_name>Ethics committee OF Nursing and Midwifery &amp; Rehabilitation schools- Tehran university  of Medical Sc</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>
