<?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>IRCT20211201053248N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-19</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive-behavioral therapy on the elderly with fear of falling</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive-behavioral therapy on the stages of planning and predicting the time of movement in the elderly with fear of falling</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60416</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Envelopes are prepared for the number of participants in the study (36 people) which are placed inside 18 envelopes of odd numbers and in the remaining 18 envelopes of even numbers and then we combine the envelopes by chance and from this random combination  Sample people select one of the envelopes and are divided into intervention and control groups, respectively, being even or odd, Blinding description: This is a one-way blind study in which the statistician is an independent person who analyzes data and is unaware of the allocation of groups.
 And the evaluator is an independent person and evaluates the consequences and is unaware of the allocation of groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of falling.</hc_freetext>
      <i_freetext>Intervention 1: The "intervention group" is treated with a combination of routine walking rehabilitation as well as cognitive-behavioral therapy to reduce the fear of falling.  Common walking rehabilitation includes a number of active range-of-motion exercises for all joints of the body, progressive strengthening exercises to guide the hip extensor and abductor, knee and dorsal extensors and flexors, and plantar flexors of the ankle, as well as other skills including transition from sitting to sitting.  Conversely, knee squats, standing on one foot, standing back and walking, walking on heels, walking on and off, spinning, stepping on, picking up objects while walking, and on stairs.  And go down.  These exercises are performed twice a week for 45 minutes for 12 weeks.  Cognitive-behavioral therapy in this group aims to reduce the fear of falling and improve self-efficacy.  This treatment has different parts, including the use of positive words before and after performing a skill move to build a negative attitude and reassurance in performing the skill.  This positivity starts as part of simple skills and progresses to more complex motor skills over distances and less support.  Another part of this method is visualizing the correct pattern of a skill before doing it.  For example, a correct gait pattern in the face of an environmental disturbance is taught by the therapist and the therapist is asked to visualize the ability to do so before doing so.  Another part of this treatment is to improve the self-efficacy of the individual.  In this case, the person discusses in his mind these questions, 'what a great success it would be if I walked in any place of fear as in the past', how he reacts to those around me against this without progress.  This treatment is done in groups (6 to 8 people in each group) once a week for 2 hours for 12 weeks. Intervention 2: Control group: Conventional gait rehabilitation is performed exactly the same as the intervention group twice a week for 45 minutes for 12 weeks.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roghaye Dive</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Seyedniaz village</address>
        <city>Gonbad Ghabos</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4977184669</zip>
        <telephone>+98 17 3324 9324</telephone>
        <email>Divehroghaye@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Asghar Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Paramedical Sciences، ‏University Campus، ‏East Door of Ferdowsi University of Mashhad، ‏Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>051 38846710_20</telephone>
        <email>hosseiniha@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fear of falling without cognitive impairment
Independence in daily activities
Able to walk at least 20 meters without aids
Ability to participate in treatment sessions
Age between 60 and 80 years</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any acute or chronic illness that affects balance and gait control
Existence of cognitive disorders
Acute psychiatric illness with psychosis</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>The "intervention group" is treated with a combination of routine walking rehabilitation as well as cognitive-behavioral therapy to reduce the fear of falling.  Common walking rehabilitation includes a number of active range-of-motion exercises for all joints of the body, progressive strengthening exercises to guide the hip extensor and abductor, knee and dorsal extensors and flexors, and plantar flexors of the ankle, as well as other skills including transition from sitting to sitting.  Conversely, knee squats, standing on one foot, standing back and walking, walking on heels, walking on and off, spinning, stepping on, picking up objects while walking, and on stairs.  And go down.  These exercises are performed twice a week for 45 minutes for 12 weeks.  Cognitive-behavioral therapy in this group aims to reduce the fear of falling and improve self-efficacy.  This treatment has different parts, including the use of positive words before and after performing a skill move to build a negative attitude and reassurance in performing the skill.  This positivity starts as part of simple skills and progresses to more complex motor skills over distances and less support.  Another part of this method is visualizing the correct pattern of a skill before doing it.  For example, a correct gait pattern in the face of an environmental disturbance is taught by the therapist and the therapist is asked to visualize the ability to do so before doing so.  Another part of this treatment is to improve the self-efficacy of the individual.  In this case, the person discusses in his mind these questions, 'what a great success it would be if I walked in any place of fear as in the past', how he reacts to those around me against this without progress.  This treatment is done in groups (6 to 8 people in each group) once a week for 2 hours for 12 weeks.</i_keyword>
      <i_keyword>Control group: Conventional gait rehabilitation is performed exactly the same as the intervention group twice a week for 45 minutes for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The time difference between the mental imagination of doing movement and the actual doing of movement. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Timed Up and Go Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of fear of falling. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Falls Efficacy Scale International.</sec_outcome>
      <sec_outcome>The risk of falling. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Dynamic Gait Index.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-11</approval_date>
        <contact_name>Ethics Committee of School of Paramedical Sciences and Health School of mashhad Mashhad University o</contact_name>
        <contact_address>Mashhad, Azadi St., East Door of Ferdowsi University of Mashhad, University Campus, Faculty of Paramedical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
