<?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>IRCT20220430054702N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-20</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of mental imagery in people with stroke</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Mental Imagery on the Occupational Performance and Life Habits of Persons with Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63300</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: The samples will then be divided into control and intervention groups by block randomization method. In the block randomization method, first all 4 blocks that contain two letters A and B are prepared (6 blocks) and we assign a number from 1 to 6 to each of them. Then, using a table of random numbers, numbers from one to six are selected (15 numbers) and the corresponding block will be written based on the selected random number. Doing so will result in a sequence of 60 letters A and B. Each sample will have a number from 1 to 60 if they enter the study, which will receive an A or B code based on the letter list based on each person's number. This is both a coincidence and both groups will be approximately the same, Blinding description: In this study, the evaluation is performed by an occupational therapist who is fluent in the tests and is not part of the research team and is not aware of the study process (the evaluator is blind).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: available samples are included in the study based on the inclusion criteria. Then clients fill part of the demographic information questionnaire and enter the intervention group (routine occupational therapy with mental imagery), daily life habits are measured using the life habits questionnaire (H-Life). Then, the work performance priorities of the samples in the three areas of productivity, self-care and leisure time are determined using the Canadian Work Performance Scale (COPM), and the intervention should be carried out on these priorities. Clients perform their priority functions with the healthy side and using video rotation software, the prepared video is returned and sent to the clients. In the video made, it seems that the person with the involved side is doing an activity, and the video contains 5 functions that are a priority for the reference, and the duration of the video for each function is one minute (5 minutes in total). . Clients should view this video of priority functions before performing the visualization. which later visualizes these priority functions during the therapy session. Intervention protocol: 1- Mental imagery intervention for the intervention group: Mental imagery includes three parts: relaxation, imagination (visualization of prioritized functions) and normalization. The relaxation part (three minutes), fantasy or visualization of priority functions (5 minutes) and normalization (two minutes), which are 10 minutes in total. Mental imagery exercises are performed three times a day (for a total of 30 minutes), 3 times a week for 4 weeks. In all parts, the person should sit in a relaxed and comfortable position (the environment should have minimal noise and distractions). The first part of relaxation: relaxation; It includes three stages of breathing exercises, visualization of a relaxing environment and muscle relaxation. The whole relaxation part lasts for 3 minutes. The first stage of sedation or respiratory sedation; The person is asked to count to 4 and inhale through the nose while counting and then hold his breath and count to 4, then while breathing out to count to 4, finally without breathing again or Exhale for a count of 4 and repeat this process for 25 seconds. The second stage of relaxation; Imagining a relaxing environment: In this step, the person is asked to create a relaxing environment by remembering a relaxing environment or through imagination (for example, a day at the beach or in the forest). The elements of the environment using each of the five senses using commands such as: What do you see? (for example, the blue color of water), . what do you hear (eg waves crashing along the shore), what do you smell? (For example, the fruity scent of sunscreen), what do you smell? (eg, salty sea air), how do you feel? (for example, the heat of the sun). In total, this stage of relaxation takes 50 seconds. The third stage of relaxation; It is muscle relaxation, which consists of 6 steps and includes the following exercises: 1. Starting from the foot, bend the toes under and contract the leg muscles. Hold for 5 seconds, then slowly release for 10 seconds. 2. Contract the calf muscles. Hold for 5 seconds, then release slowly for 10 seconds. 3. Contract the buttock muscles. Hold for 5 seconds, then slowly release for 10 seconds. 4. Contract the abdominal and chest muscles. Hold for 5 seconds, then slowly release for 10 seconds. 5. Contract the shoulder muscles. Hold for 5 seconds, then release slowly for 10 seconds. 6. Contract the muscles of the face (for example, squeeze the eyes). Hold for 5 seconds, then slowly release for 10 seconds. 7. Contract the hand muscles and make a fist. Hold for 5 seconds, then slowly release for 10 seconds. A total of 105 seconds are spent on relaxing the muscles. Second part: imagining and visualizing priority functions; In this section, the references visualize the video made of the priority functions, the duration of which is 5 minutes, and one minute of visualization is considered for each function. The third part: normalization; in this stage, the client is asked to pay attention to the surrounding environment and the real position of his body, and the duration of this stage is 2 minutes. In total, it takes 10 minutes to complete all the mental imaging sections. Therefore, in every session that the client intends to visualize, he must repeat it 3 times a day, which takes a total of 30 minutes of visualization. 2- Routine occupational therapy intervention for the intervention group: Routine occupational therapy includes; Upper body exercises for 15 minutes: carrying a cube, pegboard, holding a cup and sliding objects on the table. Also, 15 minutes of exercises for the lower body: changing from sitting to standing, reaching sitting positions, walking and crossing obstacles, turning and transferring), 30 minutes per session, 3 times a week for 4 weeks. Takes. Intervention 2: Control group: Includes routine occupational therapy, which includes upper extremity exercises for 15 minutes: carrying a cube, pegboard, holding a cup, and sliding objects on a table. Also, 15 minutes of exercises for the lower body: changing from sitting to standing, reaching sitting positions, walking and crossing obstacles, turning and transferring), 30 minutes per session, 3 times a week for 4 weeks. Takes.</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:
Data related to demographic questionnaires and Canadian life habits and performance are presented in summary form, separately and in files.

When:
The access period starts 6 months after the results are published.

To whom:
Clients and professors, advisors, guides and all researchers

Conditions:
The general researchers are allowed to use any type of analysis.

Where to obtain:
Send to the recipient's email address.

How to obtain:
Send to the recipient's email address.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Mohammad Homayoni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, Corner of Safi Alishah St., Pich Shemiran St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>a.m.homayooni@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Mohammad Homayoni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shemiran St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>a.m.homayooni@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with adult stroke are in the age range of 30-65 who have at least one chronic unilateral stroke, on the other hand, the interval between the onset of the disease is six months or more.
References can walk at least 10 meters with or without a cane.
Lack of perceptual aphasia
No unilateral neglect
No severe depression
Be literate
Lack of articular contractures affecting movement
Clients have appropriate communication skills and have a minimum mental state examination score (MMSE) of 21 and above to be able to be intervened.
Severe hemiplegic spasticity (modified Ashworth Scale score at least 3)</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any severe upper limb pain, with a score greater than or equal to 5 on the analog visual scale
Bad general conditions such as medical or orthopedic problems that have prevented clients from participating in normal rehabilitation
Combined neurological diseases such as Parkinson's disease are present in clients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vascular syndromes of brain in cerebrovascular diseases</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: available samples are included in the study based on the inclusion criteria. Then clients fill part of the demographic information questionnaire and enter the intervention group (routine occupational therapy with mental imagery), daily life habits are measured using the life habits questionnaire (H-Life). Then, the work performance priorities of the samples in the three areas of productivity, self-care and leisure time are determined using the Canadian Work Performance Scale (COPM), and the intervention should be carried out on these priorities. Clients perform their priority functions with the healthy side and using video rotation software, the prepared video is returned and sent to the clients. In the video made, it seems that the person with the involved side is doing an activity, and the video contains 5 functions that are a priority for the reference, and the duration of the video for each function is one minute (5 minutes in total). . Clients should view this video of priority functions before performing the visualization. which later visualizes these priority functions during the therapy session. Intervention protocol: 1- Mental imagery intervention for the intervention group: Mental imagery includes three parts: relaxation, imagination (visualization of prioritized functions) and normalization. The relaxation part (three minutes), fantasy or visualization of priority functions (5 minutes) and normalization (two minutes), which are 10 minutes in total. Mental imagery exercises are performed three times a day (for a total of 30 minutes), 3 times a week for 4 weeks. In all parts, the person should sit in a relaxed and comfortable position (the environment should have minimal noise and distractions). The first part of relaxation: relaxation; It includes three stages of breathing exercises, visualization of a relaxing environment and muscle relaxation. The whole relaxation part lasts for 3 minutes. The first stage of sedation or respiratory sedation; The person is asked to count to 4 and inhale through the nose while counting and then hold his breath and count to 4, then while breathing out to count to 4, finally without breathing again or Exhale for a count of 4 and repeat this process for 25 seconds. The second stage of relaxation; Imagining a relaxing environment: In this step, the person is asked to create a relaxing environment by remembering a relaxing environment or through imagination (for example, a day at the beach or in the forest). The elements of the environment using each of the five senses using commands such as: What do you see? (for example, the blue color of water), . what do you hear (eg waves crashing along the shore), what do you smell? (For example, the fruity scent of sunscreen), what do you smell? (eg, salty sea air), how do you feel? (for example, the heat of the sun). In total, this stage of relaxation takes 50 seconds. The third stage of relaxation; It is muscle relaxation, which consists of 6 steps and includes the following exercises: 1. Starting from the foot, bend the toes under and contract the leg muscles. Hold for 5 seconds, then slowly release for 10 seconds. 2. Contract the calf muscles. Hold for 5 seconds, then release slowly for 10 seconds. 3. Contract the buttock muscles. Hold for 5 seconds, then slowly release for 10 seconds. 4. Contract the abdominal and chest muscles. Hold for 5 seconds, then slowly release for 10 seconds. 5. Contract the shoulder muscles. Hold for 5 seconds, then release slowly for 10 seconds. 6. Contract the muscles of the face (for example, squeeze the eyes). Hold for 5 seconds, then slowly release for 10 seconds. 7. Contract the hand muscles and make a fist. Hold for 5 seconds, then slowly release for 10 seconds. A total of 105 seconds are spent on relaxing the muscles. Second part: imagining and visualizing priority functions; In this section, the references visualize the video made of the priority functions, the duration of which is 5 minutes, and one minute of visualization is considered for each function. The third part: normalization; in this stage, the client is asked to pay attention to the surrounding environment and the real position of his body, and the duration of this stage is 2 minutes. In total, it takes 10 minutes to complete all the mental imaging sections. Therefore, in every session that the client intends to visualize, he must repeat it 3 times a day, which takes a total of 30 minutes of visualization. 2- Routine occupational therapy intervention for the intervention group: Routine occupational therapy includes; Upper body exercises for 15 minutes: carrying a cube, pegboard, holding a cup and sliding objects on the table. Also, 15 minutes of exercises for the lower body: changing from sitting to standing, reaching sitting positions, walking and crossing obstacles, turning and transferring), 30 minutes per session, 3 times a week for 4 weeks. Takes.</i_keyword>
      <i_keyword>Control group: Includes routine occupational therapy, which includes upper extremity exercises for 15 minutes: carrying a cube, pegboard, holding a cup, and sliding objects on a table. Also, 15 minutes of exercises for the lower body: changing from sitting to standing, reaching sitting positions, walking and crossing obstacles, turning and transferring), 30 minutes per session, 3 times a week for 4 weeks. Takes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of daily life habits in the life habit(H-LIFE) questionnaire. Timepoint: The time periods of measuring life habits for the samples are done two weeks before the intervention and two weeks after the intervention. Method of measurement: Life habits(H-LIFE) questionnaires.</prim_outcome>
      <prim_outcome>Occupational performance score in the Canadian Occupational Performance measure(COPM). Timepoint: Occupational performance measurements for the samples are performed two weeks before the intervention and two weeks after the intervention. Method of measurement: Canadian Occupational Performance Measure(COPM).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-29</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Enghelab St., Pich Shemiran, corner of Safi Alishah St., School of Rehabilitation Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
