<?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>IRCT20150721023277N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-29</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Investigation of the Effect of Mental Practice on Fear Of Falling in the Community-Dwelling Elderly  .</public_title>
      <acronym></acronym>
      <scientific_title>The Investigation of the Effect of Mental Practice on Fear Of Falling during n Activity of Daily Living and Satisfaction in the Community-Dwelling Elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28359</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method will be used in which a table of random number will be used, Blinding description: This study is designed as single-blind in which participants are not aware of being in control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>old age - fear of falling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First the researcher becomes familiar with the physical condition of the participants' home by observing the video which recorded by care giver and visiting their homes. This is done to increase the researchers awareness about the layout of the objects and the type of architecture of the home environment to facilitate the preparation and presentation of mental practice program specifically. According to SAFFE questionnaire, activities which participants have fear of falling facing them, will be selected and exercises will be provided in form of these activities and tailored to the circumstances of each participant's home. They will be asked to imagine their selected activities as kinetic imagery in their minds. Intervention takes place 3 days per week (Sunday, Tuesday, Thursday), which lasts for 4 weeks. Each treatment session will be held between 8 -12 in the morning. The participants will attend in a therapeutic program for intervention in a calm and well-prepared room. Each intervention session lasts 15 minutes. The first 5 minutes are relaxation exercises, such as breathing relaxation techniques to increase comfort and concentration of participants, as well as readiness for doing mental practice. The participant is placed on an appropriate bed and then closes his/her eyes. He/She is  asked to think about the chosen activity based on the SAFFE questionnaire step by step with researcher guidance. In the following, he/she is asked to try to do this with more speed and skill at any period of intervention sessions. Duration of mental practice is calculated by stopwatch. Additionally, the traditional rehabilitation program in the form of balance exercises will also be provided to the intervention group by written instructions and consultation for exercising at home. These exercises will be performed at home in form of activities of daily living to increase balance for 4 weeks, three days per week about half an hour a day. Every 4 sessions, home interventions will be monitored by researcher  through a video check of each session recorded by caregivers. Intervention 2: Control group: The traditional rehabilitation program in the form of balance exercises will also be provided to the control group by written instructions and consultation for exercising at home. These exercises will be performed at home in form of activities of daily living to increase balance about half an hour a day,  three days per week for 4 weeks. Every 4 sessions, home interventions will be monitored by researcher through a video check of each session recorded by caregivers.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is playgerism</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Laleh Lajevardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459-13487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>lajevardi.l@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghorban Taghizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459-13487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>gh_taghizade@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a score 21 or higher from MMSE cognitive test
being at the age of 80-60 years
Having a minimum score of 24 from the Efficiency Scale, International Form (FES-I).
Having a score less than 33 in the internal visual imagery subscale, less than 20 in the external visual imagery subscale , and less than 21 in the kinesthetic imagery subscale of the VMIQ-2 questionnaire.
Having fear of falling at least in one of the activities listed in the SAFFE Test.
absence of specific visual  or hearing impairment , if present, being modifiable with adaptable equipment (based on medical records of the center).
Reading and writing skills.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Using disruptive equilibrium drugs.
Having neurological diseases such as dementia, Alzheimer's, stroke, Parkinson's and MS that causes cognitive or balance impairment (geriatric physician confirmation).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: First the researcher becomes familiar with the physical condition of the participants' home by observing the video which recorded by care giver and visiting their homes. This is done to increase the researchers awareness about the layout of the objects and the type of architecture of the home environment to facilitate the preparation and presentation of mental practice program specifically. According to SAFFE questionnaire, activities which participants have fear of falling facing them, will be selected and exercises will be provided in form of these activities and tailored to the circumstances of each participant's home. They will be asked to imagine their selected activities as kinetic imagery in their minds. Intervention takes place 3 days per week (Sunday, Tuesday, Thursday), which lasts for 4 weeks. Each treatment session will be held between 8 -12 in the morning. The participants will attend in a therapeutic program for intervention in a calm and well-prepared room. Each intervention session lasts 15 minutes. The first 5 minutes are relaxation exercises, such as breathing relaxation techniques to increase comfort and concentration of participants, as well as readiness for doing mental practice. The participant is placed on an appropriate bed and then closes his/her eyes. He/She is  asked to think about the chosen activity based on the SAFFE questionnaire step by step with researcher guidance. In the following, he/she is asked to try to do this with more speed and skill at any period of intervention sessions. Duration of mental practice is calculated by stopwatch. Additionally, the traditional rehabilitation program in the form of balance exercises will also be provided to the intervention group by written instructions and consultation for exercising at home. These exercises will be performed at home in form of activities of daily living to increase balance for 4 weeks, three days per week about half an hour a day. Every 4 sessions, home interventions will be monitored by researcher  through a video check of each session recorded by caregivers.</i_keyword>
      <i_keyword>Control group: The traditional rehabilitation program in the form of balance exercises will also be provided to the control group by written instructions and consultation for exercising at home. These exercises will be performed at home in form of activities of daily living to increase balance about half an hour a day,  three days per week for 4 weeks. Every 4 sessions, home interventions will be monitored by researcher through a video check of each session recorded by caregivers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of fear of falling in activity of daily living in the Activities-specific Balance Confidence questionnaire. Timepoint: Measure fear of falling in activity of daily living at the beginning of the study (before the intervention) and 28 days (4 weeks) after the intervention. Method of measurement: Activities-specific Balance Confidence questionnaire.</prim_outcome>
      <prim_outcome>Satisfaction in activity of daily living, the score derived from the Canadian Occupational Performance Measure. Timepoint: Measuring satisfaction degree in activity of daily living at the beginning of the study (before the intervention) and 28 days (4 weeks) after the intervention. Method of measurement: Canadian Occupational Performance Measure Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance Score in Berg Balance Scale and Functional Reach Test. Timepoint: Measurement of balance at the beginning of the study (before the intervention) and 28 days (4 weeks) after the intervention. Method of measurement: Berg Balance Scale and Functional Reach Test Questionnaire.</sec_outcome>
      <sec_outcome>Functional mobility score in Time UP and GO test. Timepoint: Measurement of functional mobility at the beginning of the study (before the intervention) and 28 days (4 weeks) after the intervention. Method of measurement: Time UP and GO test to measure functional mobility.</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>2017-08-28</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
