<?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>IRCT20230608058418N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-18</date_registration>
      <primary_sponsor>Riphah International University Faisalabad</primary_sponsor>
      <public_title>Comparison of Task-Oriented Circuit Training and Vestibular Rehabilitation Therapy on Balance, Gait and fear of falling in Elderly population.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Task-Oriented Circuit Training and Vestibular Rehabilitation Therapy on Balance, Gait and fear of falling in Elderly population.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70628</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization will be done by Random Allocation Software version 2. Participants will be divided into two groups, Blinding description: The Blinding will done by blinding the outcome accessor because Outcome accessor and Researcher will two different persons.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gait.</hc_freetext>
      <i_freetext>Intervention 1: Task-Oriented Circuit Training is a useful approach to improve balance and gait function for those having a fear of falling and abnormal gait pattern. The TOCT is based on workstations including different motor tasks related to daily living activities such as maintaining balance, walking, and reaching. TOCT may allow a more intensive (more repetitions) and specific (task-oriented) exercise in a developed rehabilitative setting. It has positive effects on gait and fall-related injuries which is more common in elderly population. Intervention 2: Vestibular Rehabilitation Therapy is exercise-based program that has been around for more than 70 years. Patients with gait issues can benefit from a form of treatment that is vestibular rehabilitation. Vestibular rehabilitation improves static and dynamic balance stability. It improves gait parameters in elderly patients, allowing patients to walk more securely and direct more easily during walking.</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 Sharing IPD may raise privacy and confidentiality concerns, especially when the data contains sensitive or personally identifiable information. There may be legal or ethical obligations to protect the privacy of the participants, and sharing their data could violate those obligations.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Vishal Sana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House#P44, Usman colony near Allied moor, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 348 6665054</telephone>
        <email>vishsana24@gmail.com</email>
        <affiliation>Riphah International University Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Vishal Sana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House#P44, Usman colony near Allied moor, Faisalabd</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 348 6665054</telephone>
        <email>vishsana24@gmail.com</email>
        <affiliation>Riphah International University Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of participants 60 or more
Have fallen at least once in the last 12 months
Taking more than 15 s, or needing support, in the timed up-and-go (TUG) test
Both genders
Identified as medium fall risk on BBS (21-40)/56</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cognitive decline that prevents the patient from understanding the assessment, vestibular rehabilitation exercises, and granting informed consent
Balance disorders caused by conditions other than age (neurologic, vestibular, etc.)
Organic conditions that prevent standing on two feet, which is necessary for a complete postural assessment and performance of vestibular rehabilitation exercises.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R26</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gait</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Task-Oriented Circuit Training is a useful approach to improve balance and gait function for those having a fear of falling and abnormal gait pattern. The TOCT is based on workstations including different motor tasks related to daily living activities such as maintaining balance, walking, and reaching. TOCT may allow a more intensive (more repetitions) and specific (task-oriented) exercise in a developed rehabilitative setting. It has positive effects on gait and fall-related injuries which is more common in elderly population</i_keyword>
      <i_keyword>Vestibular Rehabilitation Therapy is exercise-based program that has been around for more than 70 years. Patients with gait issues can benefit from a form of treatment that is vestibular rehabilitation. Vestibular rehabilitation improves static and dynamic balance stability. It improves gait parameters in elderly patients, allowing patients to walk more securely and direct more easily during walking</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before Intervention and 6 weeks after intervention. Method of measurement: Timed Up-and-Go (TUG) Test.</prim_outcome>
      <prim_outcome>Gait. Timepoint: Before Intervention and 6 weeks after intervention. Method of measurement: Dynamic Gait Index.</prim_outcome>
      <prim_outcome>Fear of falling. Timepoint: Before Intervention and 6 weeks after intervention. Method of measurement: Falls Efficacy Scale-International ( FES-I).</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>Riphah International University Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-28</approval_date>
        <contact_name>Research and Ethical Comittee</contact_name>
        <contact_address>Adjacent Fish Farm, Satayana Rd, Faisalabad, Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
