<?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>IRCT20210504051178N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-05</date_registration>
      <primary_sponsor>Iran National Science Foundation</primary_sponsor>
      <public_title>Effect of mechanichal stimulation on parkinsonian tremor and Essential tremor</public_title>
      <acronym></acronym>
      <scientific_title>Effect of skin mechanoreceptors stimulation on resting tremor in parkinsonian patients and kinetic tremor in patients with essential tremor.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60423</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Parkinson 'patients are selected , examined and grouped randomized by neurology resident. Intervention of each group is doing by biomedical engineering phd student. Neurology resident does examination of groups and gathers information but intervention of groups is unknown. Analysis of data is doing by phd student while the identity of data is not evident.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Parkinson's disease. Condition 2: Essential tremor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 5 parkinson' patients  will be intervened on the hand while it is at a rest position , consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on UDPRS criteria and accelerometer at first and final session and one month later. Intervention 2: Intervention group 2: 5 Essential tremor' patients  will be intervened on the hand while it is drawing a figure , consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on TETRAS criteria and accelerometer at first and final session and one month later. Intervention 3: Control group: We put equipment on the hand of 5 parkinson' patients  at a rest position, consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on UDPRS criteria and accelerometer at first and final session and one month later.</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 part of data can be communalized

When:
6 months after publication

To whom:
researchers of scientific institution and university

Conditions:
different analysis for researchers

Where to obtain:
Ali Shoeibi MD, Ahmad Abad Blvd, Qaem hospital, shoeibia@mums.ac.ir

How to obtain:
emailing, duration:3 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Shoeibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaem Hospital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187145785</zip>
        <telephone>+98 51 3840 0000</telephone>
        <email>shoeibia@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Shoeibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaem Hospital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187145785</zip>
        <telephone>+98 51 3840 0000</telephone>
        <email>shoeibia@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parkinson disease is diagnosed based on MDS criteria
At least one hand has rest tremor
40 years old at the onset of disease.
All patients will fill out a consent form
Kinetic tremor in hand ( Essential tremor)</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe disabilities
Neuropathy
MMSE score less than 26
Mood disorders and anxiety
treatment with DBS and apomorphine pump
Dose of drugs changed one month before
Accompany of disorders or drugs that exaggerated tremor</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
      <hc_code>G25.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
      <hc_keyword>Essential tremor</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: 5 parkinson' patients  will be intervened on the hand while it is at a rest position , consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on UDPRS criteria and accelerometer at first and final session and one month later.</i_keyword>
      <i_keyword>Intervention group 2: 5 Essential tremor' patients  will be intervened on the hand while it is drawing a figure , consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on TETRAS criteria and accelerometer at first and final session and one month later.</i_keyword>
      <i_keyword>Control group: We put equipment on the hand of 5 parkinson' patients  at a rest position, consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on UDPRS criteria and accelerometer at first and final session and one month later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tremor  severity. Timepoint: before beginning of intervention ( at the first of  sampling and start of intervention), final session, after one month. Method of measurement: part 3 of UDPRS criteria  (The Unified Parkinson's Disease Rating Scale) and accelerometer, TETRAS scoring for Essential tremor.</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>Iran National Science Foundation</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-19</approval_date>
        <contact_name>Ethics committee of mashhad university of medical sciences</contact_name>
        <contact_address>No 11. Goldis Ave, Boronsi Blvd, mashhad city Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
