<?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>IRCT20220617055200N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-23</date_registration>
      <primary_sponsor>Muhammad institute of medical and allied sciences Multan</primary_sponsor>
      <public_title>Effects of exercises on balance, gait, and kinesiophobia in elderly people</public_title>
      <acronym></acronym>
      <scientific_title>EFFECTIVENESS OF GAZE STABILITY WITH AND WITHOUT VESTIBULAR REHABILITATION ON GAIT, BALANCE, AND KINESIOPHOBIA IN ELDERLY PEOPLE</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64229</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: Allocation concealment occurs and patients will be recruited by using simple randomization through the lottery method. The lottery method is carried out through sealed envelopes. each participant will randomly choose the sealed envelopes and open this sealed envelope, Blinding description: The data analyzer was unaware of the results. The data analyzer was unaware of the treatments received by group A and group B. Data analyzer was unaware of the results.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gait imbalance.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group-B will be treated with Gaze stability with vestibular rehabilitation exercises.  A Warm-Up Exercise For 5 minutes Before the Activity Is Included As Short Walks with Normal Speed and Games with Medicine Balls, Using Hands and Feet. For Gaze Stabilization Exercise the Participants Will Make to Sit Facing a Blank Wall and Hold Out Their Thumb Straight in Front of The Therapist. Participants will be Requested to Maintain Their Eyes Fixated on Your Thumb at All Times During This Exercise, Then Turn Their Head a Little to The Right and Then to The Left. Alternate Turning from Left to Right and Back in A Rhythmic Pattern. The Transition from Left to Right Took About a Second and Went Nicely. This will be repeated 10 times. Vestibular rehabilitation exercises formed both in sitting and standing. Walked outside (moved forward, backward, and sideways at various speeds). Stand on a single-leg stance &amp; double leg stance. Several types of ground surfaces were included like foam rubber and mattresses. All activities will be performed with eyes open &amp; eyes closed. Each position allowed holding for 10 seconds.  Duration is 12 weeks 3 days a week. Intervention 2: Control group: Group-A will be treated with Gaze stability. A Warm-Up Exercise For 5 minutes Before the Activity Is Included As Short Walks with Normal Speed and Games with Medicine Balls, Using Hands and Feet. For Gaze Stabilization Exercise the Participants Will Make to Sit Facing a Blank Wall and Hold Out Their Thumb Straight in Front of The Therapist. Participants will be Requested to Maintain Their Eyes Fixated on Your Thumb at All Times During This Exercise, Then Turn Their Head a Little to The Right and Then to The Left. Alternate Turning from Left to Right and Back in A Rhythmic Pattern. The Transition from Left to Right Took About a Second and Went Nicely. Duration is 12 weeks 3 days a week.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nimra Arif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL Street near sabzazar metro station Multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 333 3877032</telephone>
        <email>angelnimra95@gmail.com</email>
        <affiliation>Muhammad institute of medical and allied sciences, Multan.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Imran Ahmad Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street near sabzazar metro station, Multan.</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 333 6120602</telephone>
        <email>imranahmadkhandurrani@gmail.com</email>
        <affiliation>Muhammad institute of medical and allied sciences, Multan.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both gender
Age 50-79 years
At least 50% of activities-specific Balance Confidence Scale</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>79 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disabled individuals were left out of the loop
Those who had serious mobility issues were not included
People who needed a walker or cane to get about were not included
Coronary artery disease patients were not included</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R26.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other abnormalities of gait and mobility</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>Intervention group: Group-B will be treated with Gaze stability with vestibular rehabilitation exercises.  A Warm-Up Exercise For 5 minutes Before the Activity Is Included As Short Walks with Normal Speed and Games with Medicine Balls, Using Hands and Feet. For Gaze Stabilization Exercise the Participants Will Make to Sit Facing a Blank Wall and Hold Out Their Thumb Straight in Front of The Therapist. Participants will be Requested to Maintain Their Eyes Fixated on Your Thumb at All Times During This Exercise, Then Turn Their Head a Little to The Right and Then to The Left. Alternate Turning from Left to Right and Back in A Rhythmic Pattern. The Transition from Left to Right Took About a Second and Went Nicely. This will be repeated 10 times. Vestibular rehabilitation exercises formed both in sitting and standing. Walked outside (moved forward, backward, and sideways at various speeds). Stand on a single-leg stance &amp; double leg stance. Several types of ground surfaces were included like foam rubber and mattresses. All activities will be performed with eyes open &amp; eyes closed. Each position allowed holding for 10 seconds.  Duration is 12 weeks 3 days a week.</i_keyword>
      <i_keyword>Control group: Group-A will be treated with Gaze stability. A Warm-Up Exercise For 5 minutes Before the Activity Is Included As Short Walks with Normal Speed and Games with Medicine Balls, Using Hands and Feet. For Gaze Stabilization Exercise the Participants Will Make to Sit Facing a Blank Wall and Hold Out Their Thumb Straight in Front of The Therapist. Participants will be Requested to Maintain Their Eyes Fixated on Your Thumb at All Times During This Exercise, Then Turn Their Head a Little to The Right and Then to The Left. Alternate Turning from Left to Right and Back in A Rhythmic Pattern. The Transition from Left to Right Took About a Second and Went Nicely. Duration is 12 weeks 3 days a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: evaluated pre treatment and post treatment. Method of measurement: time up and go test.</prim_outcome>
      <prim_outcome>Gait training. Timepoint: evaluated pre treatment and post treatment. Method of measurement: Dynamic gait index.</prim_outcome>
      <prim_outcome>Kinesiophobia. Timepoint: evaluated pre treatment and post treatment. Method of measurement: Tampa scale for kineseophobia.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>ADLs. Timepoint: evaluated pre treatment and post treatment. Method of measurement: time up and go test, gait training 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>Muhammad institute of medical and allied sciences Multan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-27</approval_date>
        <contact_name>Institiutional ethcal committee of Muhammad institute of medical and allied sciences</contact_name>
        <contact_address>HBL street near Sabzazar metro station Bosan road Multan Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
