<?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>IRCT20180627040251N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-29</date_registration>
      <primary_sponsor>Iran's National Elites Foundation</primary_sponsor>
      <public_title>Exergame and strength training on gait and balance among elderly fallers</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of 8 weeks Xbox Kinect and strength training on balance and Biomechanical parameters of gait among elderly fallers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46093</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Participants will be randomized into one of four groups (Three intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope, Blinding description: In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Fall. Condition 2: Gait. Condition 3: Posture. Condition 4: Mild cognitive impairment. Condition 5: ُStrength Exercises.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: In this group, the Exergaming training sessions are done by the Xbox Kinect, which uses Console and Kinect Sensors. The sensor is an infrared camera that diagnoses the position and movements of the player automatically and records the various activities of the participants. By selecting the games, the person is placed in front of the infrared camera and performs the movements based on the movements performed by the console. The experiment is carried out three times per week and continues for eight weeks. Each session will be 40 minutes, which includes warming up and cooling down before and after the exercise. Intervention 2: Intervention group 2: Three times per week in eight weeks of strength exercises. These exercises’ programs are including activities to improve lower limb muscle strength. Such exercises are the Theraband exercises and sit to stand exercises with chair depending on the ability of the participants. The duration of each session is 40 minutes, including warming up and cooling down before and after the exercise sessions. Intervention 3: Intervention group 3: Participants of this group perform two types of exercises including exergame and strength in each session three times per week in eight weeks. Half of the training session time is assigned to exergame (intervention one) and the other half is devoted to strength exercises (intervention two). Each session, which includes warming up and cooling down before and after the exercise, lasts for 40 minutes. Intervention 4: Control group 1: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.</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 It is not necessary to publish this information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ِDr Seyed sadradin Shojaedin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33111-15447</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>sa_shojaedin@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hassan Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33111-15447</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>Hassan.sadeghi81@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>65 years of age and older with the ability and mobility to join the group training sessions.
Had a history of falls in the previous year.
Able to walk without an Assistive Device.
Obtain score less than 24 on the Mini-mental state examination (MMSE) .
Obtain score less than 26 on the Montreal Cognitive Assessment.
No history of syncope falls.</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have acute or chronic disease with influence on balance control (e.g., Parkinson’s disease; diabetes or peripheral neuropathy).
Who participated in regular exercise programs in the last 6th month.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R29.6</hc_code>
      <hc_code>R26</hc_code>
      <hc_code>R29.3</hc_code>
      <hc_code>G31.84</hc_code>
      <hc_code>Y93.B9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Repeated falls</hc_keyword>
      <hc_keyword>Abnormalities of gait and mobility</hc_keyword>
      <hc_keyword>Abnormal posture</hc_keyword>
      <hc_keyword>Mild cognitive impairment, so stated</hc_keyword>
      <hc_keyword>Activity, other involving muscle strengthening exercises</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: In this group, the Exergaming training sessions are done by the Xbox Kinect, which uses Console and Kinect Sensors. The sensor is an infrared camera that diagnoses the position and movements of the player automatically and records the various activities of the participants. By selecting the games, the person is placed in front of the infrared camera and performs the movements based on the movements performed by the console. The experiment is carried out three times per week and continues for eight weeks. Each session will be 40 minutes, which includes warming up and cooling down before and after the exercise.</i_keyword>
      <i_keyword>Intervention group 2: Three times per week in eight weeks of strength exercises. These exercises’ programs are including activities to improve lower limb muscle strength. Such exercises are the Theraband exercises and sit to stand exercises with chair depending on the ability of the participants. The duration of each session is 40 minutes, including warming up and cooling down before and after the exercise sessions.</i_keyword>
      <i_keyword>Intervention group 3: Participants of this group perform two types of exercises including exergame and strength in each session three times per week in eight weeks. Half of the training session time is assigned to exergame (intervention one) and the other half is devoted to strength exercises (intervention two). Each session, which includes warming up and cooling down before and after the exercise, lasts for 40 minutes.</i_keyword>
      <i_keyword>Control group 1: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gait Analysis. Timepoint: Before  and after Exercise Protocol. Method of measurement: Motion analysis systems.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Static Balance. Timepoint: Before the exercise program and after exercise program. Method of measurement: Biodex Balance System SD.</sec_outcome>
      <sec_outcome>Functional Mobility. Timepoint: Before the exercise program and after exercise program. Method of measurement: Timed Up and Go test (TUG).</sec_outcome>
      <sec_outcome>Cognitive Assessment. Timepoint: Before the exercise program and after exercise program. Method of measurement: Montreal Cognitive Assessment.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Kharazmi University</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's National Elites Foundation</source_name>
      <source_name>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-12</approval_date>
        <contact_name>Ethical Committee of Kharazmi University-Iran</contact_name>
        <contact_address>Enghlab- Mofateh St. Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
