<?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>IRCT20190717044237N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-10</date_registration>
      <primary_sponsor>University of Lahore, main campus</primary_sponsor>
      <public_title>Effects of Visual Scanning Exercises on Balance, Gait and Activities of Daily Livings in Patients with Post Stroke Eye Movement Disorders; A Randomized Controlled Trial</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Effects of Visual Scanning Exercises on Balance, Gait and Activities of Daily Livings in Patients with Post Stroke Eye Movement Disorders; A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41332</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: No, Randomization description: A double-blind, randomized controlled design will be used. Assessors and patients will be blinded in the present study. They will not know about the group allocation and treatment allocation given to patients. All patients will be allocated randomly into experimental and control groups by using computer-generated random number table. All random numbers will be kept in a sealed envelope. All envelops will be kept by a third person who will not be involved in this study. For each patient a sealed envelope will be opened and mentioned group will be allocated, Blinding description: Patients and outcome assessors will be blinded in this study. Patients will not know about the treatment and group allocation and it will be achieved by random numbers. Random numbers will be kept in a sealed envelope. For each patient a sealed envelope will be opened and mentioned group will be allocated. Outcome assessors will just assess the outcomes of treatment at baseline and after four weeks in outcome measure questionnaires. They will not know that they are recording the outcome of which group so in this way they can not be biased.</study_design>
      <phase>1</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group will receive visual scanning exercises along with task-specific approach. Intervention 2: Control group: Control group will receive task-specific approach which is used as routine physiotherapy. Task specific activities will be given in following steps. Step 1: In step 1 the physiotherapist will identify the missing components of movement by asking the patient to perform task. Step II: In step II the physiotherapist advice the patient to practice those missing components which were identified in step I. Step III: In step III the physiotherapist will advise the patient to practice the task as a whole. Step IV: In step IV the task is practiced in different environments i.e engage patients in practicing the functional tasks according to the level of balance and gait functions.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All collected deidentified IPD

When:
Data will be available to other people after the completion of study and remained available till 6 months

To whom:
Data will be available to people working in academic institutions

Conditions:
Data can be accessed by communicating with principle investigator "Sana Batool" through institutional email address: sana.batool1@uipt.uol.edu.pk

Where to obtain:
Data/document is available from principle investigator "Sana Batool" through institutional email address: sana.batool1@uipt.uol.edu.pk

How to obtain:
Data/document can be accessed through communicating with principle investigator "Sana Batool" on institutional email address: sana.batool1@uipt.uol.edu.pk

Comments:
N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sana Batool, PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Lahore, Main Campus, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 99200600</telephone>
        <email>sana.batool1@uipt.edu.pk</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sana Batool, PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Lahore, Main Campus, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 99200600</telephone>
        <email>sana.batool1@uipt.edu.pk</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who suffered with eye-movement disorder either an ischemic or hemorrhagic stroke
Clinically diagnosed by a neurologist
Information on the type of stroke will be obtained from the patients’ medical records
Both male and female patients between the age group of 19–60  years
Minimum score of 7 on Mini-Mental State Examination (MMSE)
Patients in the sub-acute stage after the stroke and able to follow instructions and have the capacity to provide informed consent</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Repeated stroke
Severe dementia, identified by applying the MMSE
History of an organic disorder or major psychiatric impairment
Disability or other comorbid disease such as cancer or amputation that will limit or prevent assessment of the patients
Participation in other interventional or pharmacological studies which can affect the results of this study
Patients with vestibular problems who have positive dix-hallpike test
Patients with facial palsy •	Patients with ophthalmological problems before stroke onset
Patients suffering from balance problems as  a result of muscular problem</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>164</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>I64 Stroke, not specified as haemorrhage or infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group will receive visual scanning exercises along with task-specific approach</i_keyword>
      <i_keyword>Control group: Control group will receive task-specific approach which is used as routine physiotherapy. Task specific activities will be given in following steps. Step 1: In step 1 the physiotherapist will identify the missing components of movement by asking the patient to perform task. Step II: In step II the physiotherapist advice the patient to practice those missing components which were identified in step I. Step III: In step III the physiotherapist will advise the patient to practice the task as a whole. Step IV: In step IV the task is practiced in different environments i.e engage patients in practicing the functional tasks according to the level of balance and gait functions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Berg balance scale. Timepoint: Before intervention and at 4 weeks of intervention. Method of measurement: Scoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dynamic gait index scale to assess the gait impairments and risk of fall. Timepoint: Before and after 4 weeks of intervention. Method of measurement: A four -point ordinal scale ranging from 0-3 will be used.</sec_outcome>
      <sec_outcome>Barthel index scale to measure the activities of daily living functions. Timepoint: Before and after 4 weeks of intervention. Method of measurement: A three -point ordinal scale ranging from 0-2 will be used.</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>University of Lahore, main campus</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-20</approval_date>
        <contact_name>Institutional Review Board</contact_name>
        <contact_address>University of Lahore, Main Campus, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
