<?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>IRCT20211020052824N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Serious games for patients with mild cognitive impairment (MCI)</public_title>
      <acronym></acronym>
      <scientific_title>Development and Evaluation of Serious Games for Diagnosis and Cognitive Improvement of Patients with Mild Cognitive Impairment(MCI)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild cognitive impairment.</hc_freetext>
      <i_freetext>Intervention group:  The participants will be asked to play parts of the game as prescribed by a neurologist, three days a week, at least 45 min each time, for three months at home since the appointed date. Results of each game will be considered as a point and recorded along with the duration of the study. The proposed game will be designed for Attention and orientation, Memory, Language, and Visuospatial aspects based on the cognitive aspects of ACE-R and MMSE tests. This game will be an Android-based game which will be developed by the researchers after conducting a systematic review on the available games. The proposed game contains some little games, and each of these games will be related with a cognitive aspect of these two tests..</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 result of the systematic review regarding the game scenarios and their effectiveness.
Design consideration and the degree of correlation between the proposed game's score and the results of clinical tests.
The effect of the suggested game on the participants' cognitive abilities.

When:
From beginning of 2022

To whom:
Researchers who intended to the field of this study

Conditions:
In selection or design serious game for patients with mild cognitive impairment

Where to obtain:
Abbas Sheikhraheri

How to obtain:
Contact with sheikhtaheri.a@iums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Sheikhtaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health Management and Information Sciences, No. 6, Rashid Yasemi St. Vali –e Asr Ave, Tehran, Iran. P.O Box: 1996713883</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۳۸۸۳</zip>
        <telephone>+98 21 8879 4301</telephone>
        <email>Sheikhtaheri.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Sheikhtaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health Management and Information Sciences, No. 6, Rashid Yasemi St. Vali –e Asr Ave, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8879 4301</telephone>
        <email>Sheikhtaheri.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A neurologist should confirm the initial diagnosis of MCI in patients.
Participants should have almost the same medical test results.
They should be willing to participate in the study and complete the informed consent form.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants have disabilities in the upper limbs.
participants have other mental health problems according to the neurologist.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G31.84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild cognitive impairment, so stated</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  The participants will be asked to play parts of the game as prescribed by a neurologist, three days a week, at least 45 min each time, for three months at home since the appointed date. Results of each game will be considered as a point and recorded along with the duration of the study. The proposed game will be designed for Attention and orientation, Memory, Language, and Visuospatial aspects based on the cognitive aspects of ACE-R and MMSE tests. This game will be an Android-based game which will be developed by the researchers after conducting a systematic review on the available games. The proposed game contains some little games, and each of these games will be related with a cognitive aspect of these two tests.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mini–Mental State Examination (MMSE) test score. Timepoint: At beginning of study and after three months. Method of measurement: This outcome will be measured using standard Mini–Mental State Examination (MMSE) test. MMSE is the most common test applied to assess cognitive impairment.  MMSE  has been translated into Persian and validated for Iranians. Implementing MMSE will be accomplished by a neurologist in Brain and Cognition Clinic in Iran University of Medical Sciences at the beginning of the study. At the end of three months, MMSE will be retaken from the participants by the same neurologist at the same location.</prim_outcome>
      <prim_outcome>Addenbrooke’s Cognitive Examination (ACE_R) test score. Timepoint: At beginning of study and after three months. Method of measurement: This outcome will be measured عsing Addenbrooke’s Cognitive Examination-Revised version tools.  This test examines memory, language, and visual-spatial skills more broadly than MMSE and includes verbal fluency components. ACE-R has been translated into Persian and validated for Iranians. Implementing ACE-R will be accomplished by a neurologist in Brain and Cognition Clinic in Iran University of Medical Sciences at the beginning of the study. At the end of three months, ACE-R will be retaken from the participants by the same neurologist at the same location.</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 University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-24</approval_date>
        <contact_name>Research Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahid Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
