<?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>IRCT20200505047313N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-06</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of acupressure and foot reflexology on fatigue in  Parkinson's disease</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of acupressure and foot reflexology on fatigue in Elderly with Parkinson's disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47726</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The time block method is such that from the beginning a block is considered for each week (one week of intervention block 1, one week of intervention block 2 and one week of control block). Lottery is also used to select the intervention(1,2) and control block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson disease.</hc_freetext>
      <i_freetext>Intervention 1: Control group receives common pharmacological treatments for fatigue (levodopa, dopaminergic agonists, central nervous system stimulants, and depression) and common self-care recommendations to reduce fatigue(Do your favorite activities and  meetings when they have the most energy, first do the things that matter most to them, if they don't have the energy to meet friends and relatives in person, by phone or the Internet. Communicate, when they have more energy to eat. Intervention 2: In the intervention group 1, the caregiver performs foot reflexology three times a week for one month for 18 minutes per session, in the areas of solar plexus, kidney area, spinal cord,sole of the foot for the elderly. The  duration of massage in each area is 3 minutes. Intervention 3: In the intervention group 2, the caregiver performs acupressure three times a week for one month for 18 minutes per session, in points of  ST36 both feet,HT7 both  hands ,Yin tang which is located between the two eyebrows, for his/her elderly. The duration   of massage in each area is 3 minutes.</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:
All potential data can be shared after people have not been identified

When:
The access period is 6 months after the results are printed

To whom:
Data will only be available to researchers working at academic and scientific institutions

Conditions:
The prerequisite for submitting a request for access to data and documents is its use in the clinic and comparison with the results of the research

Where to obtain:
To send a request to receive data, please refer to Elnaz Sadeghi with phone number  09196122557 and e-mail address sadeghie971@mums.ac.ir or sadeghielnaz130@gmail.com

How to obtain:
After sending the request by phone or email and mentioning the scientific position and the reason for accessing the data In case of discretion, the data will be sent within one day after

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elnaz Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Blvd,ِDormitory campus Mashhad university of Medical science</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3852 8511</telephone>
        <email>sadeghie971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>maryam salehian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibnsina Ave, Nursing and Midwifery school</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3852 8511</telephone>
        <email>SalehianMR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The elder is 60 to 85 years old
Be able to speak and understand Persian language
He or she get Score more then 6 AMTS test
Having a caregiver with inclusion criteria for entering the study to perform the intervention.
Elderly fatigue is greater than 48 according to multidimensional measurements
Have the health of the limb at the site of the intervention ( foot, hand and between the two eyebrows)
The elderly, have given written consent
Caregiver, lives with the  elderly
Caregiver should have the ability to move their hands for reflexology and acupressure
Caregiver, has a level of education  higher than fifth grade
Caregiver, is able to speak and understand Persian language
Caregiver, have  access to mobile phone
The caregiver, have given written consent</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Injuries, fractures, or lesion occur at the site of the intervention
The elder is reluctant to participate in the study
The caregiver is reluctant to participate in the stud</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group receives common pharmacological treatments for fatigue (levodopa, dopaminergic agonists, central nervous system stimulants, and depression) and common self-care recommendations to reduce fatigue(Do your favorite activities and  meetings when they have the most energy, first do the things that matter most to them, if they don't have the energy to meet friends and relatives in person, by phone or the Internet. Communicate, when they have more energy to eat</i_keyword>
      <i_keyword>In the intervention group 1, the caregiver performs foot reflexology three times a week for one month for 18 minutes per session, in the areas of solar plexus, kidney area, spinal cord,sole of the foot for the elderly. The  duration of massage in each area is 3 minutes.</i_keyword>
      <i_keyword>In the intervention group 2, the caregiver performs acupressure three times a week for one month for 18 minutes per session, in points of  ST36 both feet,HT7 both  hands ,Yin tang which is located between the two eyebrows, for his/her elderly. The duration   of massage in each area is 3 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue score in the multi-dimensional fatigue questionnaire( Smets). Timepoint: immediately before the intervention, immediately after the intervention  and one month after the last intervention session. Method of measurement: Multidimensional fatigue inventory of Smets.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression score geriatric depression questionnaire. Timepoint: before the intervention begins,Immediately after the intervention, one month after the first intervention session. Method of measurement: geriatric  Depression Questionnaire: This questionnaire contains 15 questions.</sec_outcome>
      <sec_outcome>Daily drowsiness Epworth questionnaire. Timepoint: before the intervention begins,Immediately after the intervention, one month after the first intervention session. Method of measurement: The 7-question daily drowsiness Epworth questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-28</approval_date>
        <contact_name>Ethics committee of Mashhad university of Medical Science</contact_name>
        <contact_address>Deputy of Research and Technology,next to Hoveyzeh Cinema, Ghorashi Building,Daneshgah Ave,Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
