<?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>IRCT20250216064740N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Visual Rehabilitation on Activities of Daily living and Cognition of People with Stroke</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Visual Rehabilitation Interventions on Activities of Daily living and Cognition of People with Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81952</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: After meeting the study inclusion criteria, stroke patients will be divided into two groups using the random allocation method. The permuted block method will be used for random allocation, Blinding description: The initial and final assessments of participants will be conducted by another occupational therapy master’s student who is unaware of the grouping of participants, in accordance with the principles of blinding. For this purpose, coding will be used to identify participants so that the assessor is unaware of the group status.
The data analyst will also be unaware of the grouping and will be blinded, in accordance with the principles of data coding.</study_design>
      <phase>2-3</phase>
      <hc_freetext>stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will receive Visual rehabilitation interventions based on Warren's hierarchical model of visual processing (twelve 45-minute therapy sessions, 3 times a week), alongside conventional occupational therapy interventions (twelve 30-minute therapy sessions, 3 times a week). The first and last sessions will be for assessment, and the remaining sessions (10 sessions) will be for implementation of the interventions. Interventions implemented in visual rehabilitation sessions will include: a variety of exercises related to eye movements (saccadic, pursuit, convergent, and divergent movements), visual attention, visual scanning, pattern recognition, visual memory, and visual perception skills (including: visual figure-ground, visual closure, form constancy, spatial relationships, visual sequential memory, and visual discrimination). Intervention 2: Control group: This group will receive only the conventional occupational therapy interventions (twelve 30-minute therapy sessions, 3 times a week). The first and last sessions will be for assessment, and the remaining sessions (10 sessions) will be for implementation of interventions. Interventions implemented in these sessions will include: preparation of clients, adjustment of muscle tone, balance exercises in sitting and standing positions, mobility exercises, improvement of upper limb function (gross and fine movements), and training in activities of daily living.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amin MansourLakouraj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Tehran University of Medical Sciences, pich Shamiran, Corner of Safi Alishah Street, Enghelab Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>a-mansourlakouraj@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amin MansourLakouraj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Tehran University of Medical Sciences, pich Shamiran, Corner of Safi Alishah Street, Enghelab Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>a-mansourlakouraj@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>History of only one stroke
Age range 24 to 65 years
Obtaining a minimum score of 60/20 visual acuity on the Snellen chart
It has been 1 to 6 months since the stroke.
Deficits in visual perception skills using the TVPS test and obtaining a score lower than 85
Ability to follow instructions and complete tests
Ability to successfully perform vergence, duction, and near point of convergence (NPC) tests</inclusion_criteria>
      <agemin>24 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of recurrent strokes and transient ischemic attacks (TIAs) or occurrence of these events during the study
Presence of visual impairments due to diabetes, cataracts, etc.
Visual field deficit
Presence of aphasia and inability to communicate verbally
Having serious cardiovascular, respiratory, digestive, etc. diseases.
Presence or occurrence of other neurological disorders, psychiatric diseases, serious cardiovascular, respiratory, digestive diseases, etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>164</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stroke, not specified as haemorrhage or 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: This group will receive Visual rehabilitation interventions based on Warren's hierarchical model of visual processing (twelve 45-minute therapy sessions, 3 times a week), alongside conventional occupational therapy interventions (twelve 30-minute therapy sessions, 3 times a week). The first and last sessions will be for assessment, and the remaining sessions (10 sessions) will be for implementation of the interventions. Interventions implemented in visual rehabilitation sessions will include: a variety of exercises related to eye movements (saccadic, pursuit, convergent, and divergent movements), visual attention, visual scanning, pattern recognition, visual memory, and visual perception skills (including: visual figure-ground, visual closure, form constancy, spatial relationships, visual sequential memory, and visual discrimination).</i_keyword>
      <i_keyword>Control group: This group will receive only the conventional occupational therapy interventions (twelve 30-minute therapy sessions, 3 times a week). The first and last sessions will be for assessment, and the remaining sessions (10 sessions) will be for implementation of interventions. Interventions implemented in these sessions will include: preparation of clients, adjustment of muscle tone, balance exercises in sitting and standing positions, mobility exercises, improvement of upper limb function (gross and fine movements), and training in activities of daily living.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>OculoMotor score in the OculoMotor Assessment Tool. Timepoint: At the beginning of the study (before the start of the interventions) and at the end of the study (after 10 intervention sessions). Method of measurement: OculoMotor Assessment Tool (OMAT).</prim_outcome>
      <prim_outcome>Visual Perceptual Skills Score on the Test of Visual Perceptual Skills-3. Timepoint: At the beginning of the study (before the start of the interventions) and at the end of the study (after 10 intervention sessions). Method of measurement: Test of Visual Perceptual Skills-3 (TVPS-3).</prim_outcome>
      <prim_outcome>Visual-Motor Integration Score on the Beery-Buktenica Developmental Test of Visual-Motor Integration. Timepoint: At the beginning of the study (before the start of the interventions) and at the end of the study (after 10 intervention sessions). Method of measurement: Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI-6).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Independence in activities of daily living based on the Functional Independence Measure. Timepoint: At the beginning of the study (before the start of the interventions) and at the end of the study (after 10 intervention sessions). Method of measurement: Functional Independence Measure (FIM).</sec_outcome>
      <sec_outcome>Global cognitive function score based on the Mini-Mental State Examination. Timepoint: At the beginning of the study (before the start of the interventions) and at the end of the study (after 10 intervention sessions). Method of measurement: Mini-Mental State Examination (MMSE).</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>2025-02-15</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation - Tehran University o</contact_name>
        <contact_address>school of Rehabilitation, Tehran University of Medical Sciences, pich Shamiran, Corner of Safi Alishah Street, Enghelab Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
