<?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>IRCT20200127046275N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-22</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effects of intensive multidimensional trunk training exercises combined with dual-task compared to routine physiotherapy on balance, mobility, and fall in stroke patients; a randomized controlled clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>Effects of intensive multidimensional trunk training exercises combined with dual-task compared to routine physiotherapy on balance, mobility, and fall in stroke patients; a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45396</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomisation was centralised and computerised with concealed randomisation sequence in an enclosed envelope carried out at an external site by independent personnel, Blinding description: Independent assessors, who were not familiar with the aims and objectives of the study, assessed &amp; evaluated the patients' outcomes. Furthermore, all trial participants were informed about blind outcome assessments and its importance and requested not to reveal their group allocation on the following occasions:
1. Baseline assessment; both immediately prior to, and after, randomization.
2. On each time when participants were requested to arrange follow-up visits.
3. At the commencement of each follow-up visit
The outcome assessor had no access to any study data and therapist/personnel involved in the study, no access to the password-protected study database controlled by the Data Safety and Monitoring Board and no access to completed assessments, treatment notes or questionnaires. The follow-up questionnaire item was used to measure outcome assessor’s awareness of group allocation during
follow-up visits. Therapists who provided the care to the patients were unaware of the identity of the assessors. If any support were needed to therapist and assessors, the lead research was responsible to provide all the guidance to them in strict accordance with the Data Safety and Monitoring Board. The Board does not allow the lead researcher to have direct contact and meet with the assessors anywhere except permitted site. In case of provision of any support, he had to provide video-recorded evidence of the support given to the assessors to prevent the breach in blinding. Data analyser was kept blinded by coding groups, participants and their assessments, and he did not have any direct or indirect access to the patients or personnel involved in the study. He was also completely unaware of the aims &amp;  objectives of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vascular syndromes of brain in cerebrovascular diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Multidimensional trunk exercises combine with cognitive dual-task for 40 minutes in each session, 5 times per week for 3 months. Instruments used are plinth, physio balls, balance/wobble board, thera-bands timed watch. Flexibility exercises (A &amp; PROM, stretches) 15 minute in each session, 5 sessions in a week for three months. Task-oriented exercises including gait training for 60 minutes per session, 5 sessions per week for 3 months. Instruments used are body weight support treadmill and also depend upon the goals and task of the patients. Intervention 2: Control group: Trunk exercises without dual-task for 40 minutes per session, 5 times per week for 3 months. Instruments used are plinth, physio balls, balance/wobble board, thera-bands timed watch. Flexibility exercises (A &amp; PROM, stretches) 15 minute per session, 5 sessions in a week for three months. Task-oriented exercises including gait training for 60 minutes per session, 5 sessions per week for 3 months. Instruments used are body weight support treadmill and also depend upon the goals and task of the patients.</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 Permission from Institutional Review Board of the University of Lahore require</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Umair Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 - KM Defence Road, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54770</zip>
        <telephone>+92 42 35321761</telephone>
        <email>umair.ahmed@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>DR Umair Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 - KM Defence Road, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54770</zip>
        <telephone>+92 42 86705503</telephone>
        <email>umair.ahmed@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient with score 24 or over on Mini-Mental Status Examination
Patient with ability to stand 30 second or more without any assistance
Patient with an ability to sit independently at least for 30 seconds on a stable surface</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with comorbid conditions such as cerebellar disorders, Parkinson’s disease, a vestibular lesion, arthritis or degenerative diseases of the lower limbs affecting motor performance
Patient with self-reported problems  with device use (orthopedic, medical, and/or painful conditions)
A body mass index greater than 31 kg/m 2 who are not able to perform exercises for 30 minutes or longer.
Patient with medical contraindication against trunk exercise
Patient with pusher syndrome.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vascular syndromes of brain in cerebrovascular diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Multidimensional trunk exercises combine with cognitive dual-task for 40 minutes in each session, 5 times per week for 3 months. Instruments used are plinth, physio balls, balance/wobble board, thera-bands timed watch. Flexibility exercises (A &amp; PROM, stretches) 15 minute in each session, 5 sessions in a week for three months. Task-oriented exercises including gait training for 60 minutes per session, 5 sessions per week for 3 months. Instruments used are body weight support treadmill and also depend upon the goals and task of the patients.</i_keyword>
      <i_keyword>Control group: Trunk exercises without dual-task for 40 minutes per session, 5 times per week for 3 months. Instruments used are plinth, physio balls, balance/wobble board, thera-bands timed watch. Flexibility exercises (A &amp; PROM, stretches) 15 minute per session, 5 sessions in a week for three months. Task-oriented exercises including gait training for 60 minutes per session, 5 sessions per week for 3 months. Instruments used are body weight support treadmill and also depend upon the goals and task of the patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mobility &amp; Balance. Timepoint: Before intervention , post intervention (12 weeks),  two follow up measurements with 6 months interval after post-intervention. Method of measurement: Time up and go test, timed walking test, go up and down standard 10 stairs.</prim_outcome>
      <prim_outcome>Trunk motor performance. Timepoint: Before intervention , post intervention (12 weeks),  two follow up measurements with 6 months interval after post-intervention. Method of measurement: Trunk impairment scale, postural assessment scale for stroke patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fall risk. Timepoint: Before intervention , post intervention (12 weeks), two follow up measurements with 6 months interval after post-intervention. Method of measurement: Fall risk is assessed by fall risk assessment tool.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-06</approval_date>
        <contact_name>Institutional review board</contact_name>
        <contact_address>1 - KM defence road, Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
