<?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>IRCT20140304016830N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-07</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of occupational therapy interventions on balance and participation in activities of daily living in people with chronic stroke</public_title>
      <acronym></acronym>
      <scientific_title>A randomized controlled trial to compare the effect of occupation-based interventions with and without motivational strategies on functional balance, postural control and participation in activities of daily living in people with chronic stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43839</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed by the person who is not involved in the study using sealed envelopes method, Blinding description: Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind on the groups allocation. Patients are also blind to the type of intervention they receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Control group: receives conventional rehabilitation (including exercises for upper and lower limb stretching, range of motion and activities of daily living). Intervention 2: First Intervention group: Occupation-based interventions with motivational strategies group that receives 12 sessions of intervention including different occupations with emphasize on motor learning approach (6 weeks, 2 sessions per week, 75 minutes per session) in addition to the conventional rehabilitation. In this group, different motivational strategies will be used to enhance an individual's level of motivation during the intervention. Intervention 3: Second Intervention group: Occupation-based interventions without motivational strategies group that receives 12 sessions of intervention including different occupations with emphasize on motor learning approach (6 weeks, 2 sessions per week, 75 minutes per session) in addition to the conventional rehabilitation. In this group, motivational strategies will not be used during the intervention.</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:
After the completion of this study, a manuscript regarding the documentation and the results of the study will be prepared and published. If more details are needed, individuals can send their request by email to the person responsible for scientific accountability.

When:
One year after publishing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Use of the documentation is permitted upon written permission.

Where to obtain:
Ghorban Taghizadeh Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehranو Tel: 00982122227124و E-mail: taghizadeh.gh@iums.ac.ir

How to obtain:
Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghorban Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>taghizadeh.gh@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghorban Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>taghizadeh.gh@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the first experience of stroke
Passing at least 6 months since stroke
Ability to walk at least 10 meters with or without assistive device
Ability to stand for at least 5 minutes on the foam surface
Having an acceptable level of cognitive function, i.e. score equal to or greater than 23 on the Persian version of Mini Mental State Examination
Feeling the need or desire to participate in occupations selected for the intervention</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having unilateral visuospatial neglect (i.e., obtaining score less than 44 at star cancellation test)
Co-morbid other neurological diseases, orthopedic disorders (such as low back pain and arthritis), diabetes or addiction according to the report of the patient, or patient's family or physician</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I64</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>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: receives conventional rehabilitation (including exercises for upper and lower limb stretching, range of motion and activities of daily living).</i_keyword>
      <i_keyword>First Intervention group: Occupation-based interventions with motivational strategies group that receives 12 sessions of intervention including different occupations with emphasize on motor learning approach (6 weeks, 2 sessions per week, 75 minutes per session) in addition to the conventional rehabilitation. In this group, different motivational strategies will be used to enhance an individual's level of motivation during the intervention.</i_keyword>
      <i_keyword>Second Intervention group: Occupation-based interventions without motivational strategies group that receives 12 sessions of intervention including different occupations with emphasize on motor learning approach (6 weeks, 2 sessions per week, 75 minutes per session) in addition to the conventional rehabilitation. In this group, motivational strategies will not be used during the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postural control parameters (including velocity and amplitude of center of pressure sways recorded by force plate). Timepoint: Before and after intervention and 6 weeks after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Functional balance. Timepoint: Before and after intervention and 6 weeks after intervention. Method of measurement: Timed Up and Go test, Berg balance scale.</prim_outcome>
      <prim_outcome>Level of participation in activities of daily living. Timepoint: Before and after intervention and 6 weeks after intervention. Method of measurement: Canadian occupational performance measure,  Meaningful Activity Participation Assessment Questionnaire.</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>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
