<?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>IRCT20211022052835N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-14</date_registration>
      <primary_sponsor>Shifa Tameer-e-Millat University</primary_sponsor>
      <public_title>Effectiveness of Dual task training vs Nintendo Wii-fit to improve balance among older adults</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Dual task training vs Nintendo Wii-fit to improve balance among older adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61778</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 simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study. After taking consent from the older adult for their participation in the study, the therapist opens the envelop and give the respective protocol to the individual. The study is single blinded as participants is not aware of the intervention group they are placed in. Elders will be placed either in to the experimental group 1 (Dual task training DTT) or experimental group 2 (NWF Nintendo Wii-fit) keeping the process completely randomized ,sealed envelope method will be used, Blinding description: Prior to collecting data,  participants would be informed about both the treatment techniques used in both groups; experimental group A (DDT) and experimental group B (NWF). Further they are informed that you will get one of these treatment depending upon the group written on the card inside the envelop you choose. The group A or B belongs to which way of treatment is known to therapist but the patient doesn't know about it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Unsteadiness on feet, Difficulty in balancing.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention for DDT group:•	Week 1-6 (30 – 40minutes )•	Warm up 5mintues •	Balance training •	Dynamic weight shifting , shifting with eyes •	Closed/open ,transfer , standing static/•	Dynamic , internal and external perturbations with timing and speed , •	Reaching and walking forward and backward, tandem sideways walk , up and down stairs (plain and foam obstacles)                                                                                                                                                                 •	Week 6-12 (30-40minutes)•	Dual task walking with subtraction n addition •	Placing pencil in holes of covered cup , •	Walking with fully filled glass of water , transferring objects at different heights , walking with Toss a ball from one hand to the other•	Bounce a ball. Intervention 2: Intervention group: Intervention for NWT group •	Week 1-6     30 minutes •	Warm up for 5 minutes  •	Soccer heading game•	Yoga tree pose (once)•	Week 6-12     10+10+10 minutes•	Soccer heading•	Ski slalom•	Table tilt•	Yoga tree pose (3 times).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fouzia Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 332 7120385</telephone>
        <email>fouzia_dpt.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer-e-Millat University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fouzia Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 332 7120385</telephone>
        <email>fouzia_dpt.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer-e-Millat University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female above 60 yrs.
Able to stand , no use of walking device
Mini mental status Examination those who scored more than 24 will be enrolled in study
Berg balance range 52 or less  points out of 56 will be included
Ability to walk 10m without the assistance of another person;</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Psychiatric disorder, inability to walk.
Who are unable to ambulate without assistive devices
Musculoskeletal impairment/injury
Medical conditions and medication affecting</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R26.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unsteadiness on feet</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention for DDT group:•	Week 1-6 (30 – 40minutes )•	Warm up 5mintues •	Balance training •	Dynamic weight shifting , shifting with eyes •	Closed/open ,transfer , standing static/•	Dynamic , internal and external perturbations with timing and speed , •	Reaching and walking forward and backward, tandem sideways walk , up and down stairs (plain and foam obstacles)                                                                                                                                                                 •	Week 6-12 (30-40minutes)•	Dual task walking with subtraction n addition •	Placing pencil in holes of covered cup , •	Walking with fully filled glass of water , transferring objects at different heights , walking with Toss a ball from one hand to the other•	Bounce a ball</i_keyword>
      <i_keyword>Intervention group: Intervention for NWT group •	Week 1-6     30 minutes •	Warm up for 5 minutes  •	Soccer heading game•	Yoga tree pose (once)•	Week 6-12     10+10+10 minutes•	Soccer heading•	Ski slalom•	Table tilt•	Yoga tree pose (3 times)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before intervention, 4, 8 week after intervention. Method of measurement: Berg balance test, Time up and go test, Activities-Specific Balance Confidence (ABC) Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical performance. Timepoint: Before intervention, 4 and 8 weeks after intervention. Method of measurement: Physical performance tests for measuring multiple domains of physical function.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention, 4 and 8 weeks after intervention. Method of measurement: SF-36.</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>Shifa Tameer-e-Millat University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-22</approval_date>
        <contact_name>Institutional Review Board &amp; Ethics Committee (IRB &amp; EC) Shifa International Hospital Ltd. (SIH), Sh</contact_name>
        <contact_address>Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad Islamabad Islamabad Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
