<?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>IRCT2017071916830N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-09</date_registration>
      <primary_sponsor>Vice Chancellor for research, Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rehabilitation exercises on balance in patients with chronic stroke</public_title>
      <acronym></acronym>
      <scientific_title>A randomized controlled trial to investigate the effect of sensory reweighting as a method of balance exercises on postural control, functional balance and mobility, activities of daily living, anxiety and stress suffering from chronic stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15618</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization will be performed by the person who is not involved in the study using sequentially numberd sealed envelopes.</study_design>
      <phase>3</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Control group: receives conventional rehabilitation. Intervention 2: Intervention group: In addition to conventional rehabilitation, receives 24 sessions of sensory reweighting as a method of balance exercises (8 weeks, 3 sessions per week, 45-60 minutes per session). Exercises include proprioceptive, visual, vestibular, combination of proprioceptive and vestibular, combination of visual and vestibular and combination of proprioceptive and visual stimulations.</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></results_IPD_plan>
      <results_IPD_description></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></zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>gh_taghizade@yahoo.com; 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></zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>gh_taghizade@yahoo.com; 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>Inclusion criteria: Having the first experience of stroke; Ability to walk 10 meters without assistive devices; Having an acceptable level of cognitive function, i.e. score equal to or greater than 23 on the Mini Mental State Examination; Having at least fifth grade education; Having the ability to perform the most difficult condition of laboratory test (quiet standing for 180 seconds while vibration is applied on the Achilles tendons of both sides and attention to visual stimulus); Ability to read a sentence from the screen at a distance of 2 meters. Exclusion criteria: Co-morbid other neurological diseases, orthopedic disorders (such as low back pain, arthritis, hallux valgus, flat foot), diabetes or addiction according to the report of patient, or the patient's family or physician; History of falling during the past month according to the report of patient, or the patient's family.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: receives conventional rehabilitation.</i_keyword>
      <i_keyword>Intervention group: In addition to conventional rehabilitation, receives 24 sessions of sensory reweighting as a method of balance exercises (8 weeks, 3 sessions per week, 45-60 minutes per session). Exercises include proprioceptive, visual, vestibular, combination of proprioceptive and vestibular, combination of visual and vestibular and combination of proprioceptive and visual stimulations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postural control. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Force plate (postural sway parameters).</prim_outcome>
      <prim_outcome>Functional balance and mobility. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Fuctional reach test, Berg Balance Scale Questionnaire, Timed Up &amp; Go Test, Tinetti Balance test, Six Minute Walk Test, Activities-Specific Balance Confidence Scale Questionnaire, Dynamic gait index Questionnaire, gait speed.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Beck Anxiety Questionnaire, Hamilton Anxiety Scale Questionnaire, Depression, Anxiety, Stress Scales (DASS) Questionnaire.</prim_outcome>
      <prim_outcome>Activities of daily living. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Barthel Index Questionnaire.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Depression, Anxiety, Stress Scales (DASS) Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Participation. Timepoint: Before and after intervention and and 8 weeks after intervention. Method of measurement: Canadian occupational performance measure Questionnaire.</sec_outcome>
      <sec_outcome>Instrumental activities of daily living. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Lawton Instrumental activities of daily living Scale Questionnaire.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: Before and after intervantion and 8 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index Questionnaire.</sec_outcome>
      <sec_outcome>Fatigue. Timepoint: Before and after intervantion and 8 weeks after intervention. Method of measurement: Fatigue severity scale Questionnaire, Visual analog scale of fatigue.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and after intervantion and 8 weeks after intervention. Method of measurement: World health organization quality of life assessment Questionnaire.</sec_outcome>
      <sec_outcome>Fear of fall. Timepoint: Before and after intervantion and 8 weeks after intervention. Method of measurement: Fall efficacy scale Questionnaire.</sec_outcome>
      <sec_outcome>Pain. Timepoint: Before and after intervantion and 8 weeks after intervention. Method of measurement: Brief pain inventory Questionnaire, Short-Form McGill Pain Questionnaire, Visual analog scale of pain.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before and after intervantion and 8 weeks after intervention. Method of measurement: Depression Anxiety Stress Scales (DASS) Questionnaire, Visual analog scale of depression.</sec_outcome>
      <sec_outcome>Functional balance. Timepoint: Before and after intervantion and 8 weeks after intervention. Method of measurement: Duration of standing on each leg with open and closed eyes, Duration of tandem standing with open and closed eyes.</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>Vice Chancellor for research, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-11</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  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
