<?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>IRCT20170516034003N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-24</date_registration>
      <primary_sponsor>Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The effects of modified constraint-induced movement therapy and functional electrical  stimulation in stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of modify constraint-induced movement therapy and  functional electrical  stimulation on  upper extremity function in patients with stroke in sub acute stage of  recovery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30197</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The grouping method will be Permuted block randomization . So, blocks of 10 people including 5 participants in the intervention group and 5 participants in the control group are allocated, Blinding description: The examiner won't know anything about the kind of treatment. Therapists will also not know anything about grouping and kind of interventions.</study_design>
      <phase>3</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  For this group of patients, functional electrical stimulation (FES) and exercise with modified constraint induced movement therapy will performed. Intervention 2: Control group:  For this group of patients, FES and exercise will performed.</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:
Some data will be shared if required.

When:
Accessibility about 6 month after publishing the results.

To whom:
Researchers in scientific and academic institutes

Conditions:
More analysis in specific conditions

Where to obtain:
2-Email
2- Telephone

How to obtain:
A letter with the reasons of requiring data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kamran Ezzati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy section, Block 2, , Poursina hospital, Namjoo St, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۳۷۱۳۱۹۴</zip>
        <telephone>+98 13 3332 2444</telephone>
        <email>Ez_kamran@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kamran Ezzati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy section, Block 2, , Poursina hospital, Namjoo St, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۳۷۱۳۱۹۴</zip>
        <telephone>+98 13 3332 2444</telephone>
        <email>Ez_kamran@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The history of lacunar brain stroke, which is diagnosed on the basis of CT scans and lasts from one week to three months
Middle-aged men and women (over 45 years of age) with diagnosis of stroke
The mother tongue is Persian and is able to understand oral instructions
It is able to open the wrists and fingers and two other fingers at 10 degrees
Patients who are able to maintain balance in sitting conditions. That means they can sit up to 30 seconds without help and support
The severity of the disease will be, according to the National Institutes of Health Stroke Scale(NIHSS)scale, an average NIHSS = 8-16</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of arm or hand disability
Patients with shoulder and shoulder pain
Patients with cognitive impairment or, in other words, Mini–Mental State Examination(MMSE) scores below 24
Patients with a history of other neurological diseases including Parkinson's disease, multiple sclerosis and traumatic brain injury in their medical records.
Patients with cerebral hemorrhage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction</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:  For this group of patients, functional electrical stimulation (FES) and exercise with modified constraint induced movement therapy will performed</i_keyword>
      <i_keyword>Control group:  For this group of patients, FES and exercise will performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The overall performance score of the tests is based on the Wolf test. According to Wolf's ability to perform an arm, the scores are between zero and five, with a score of 0 means the absence of the affected limb and a score of five, meaning a move close to the normal. Finally, the median time and total scores will be recorded as a total score. Timepoint: Before the intervention, 10 and 30 days after the intervention. Method of measurement: Wolf's Questionnaire.</prim_outcome>
      <prim_outcome>The time of the tests will be recorded based on the Wolf test according to the Wolf Mean Time Scale and the total performance scores as the total score. Timepoint: Before the intervention, 10 and 30 days after the intervention. Method of measurement: Wolf's Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-03</approval_date>
        <contact_name>Ethical Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>5th floor, Central office of Guilan University of Medical Sciences, Namjoo St., Rasht, Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
