<?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>IRCT20190715044216N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-09</date_registration>
      <primary_sponsor>Kanaan Physiotherapy &amp; Spine clinic</primary_sponsor>
      <public_title>EFFECT OF VIRTUAL REALITY TRAINING AND ROUTINE PHYSICAL THERAPY ON BALANCE AND FUNCTIONAL INDEPENDENCE IN STROKE PATIENTS</public_title>
      <acronym>VRTSP</acronym>
      <scientific_title>EFFECT OF VIRTUAL REALITY TRAINING AND ROUTINE PHYSICAL THERAPY ON BALANCE AND FUNCTIONAL INDEPENDENCE IN STROKE PATIENTS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2639-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/40898</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Patients will be randomly allocated in two groups of 34 patients each i.e. Virtual Reality Group and Routine Physical Therapy Group by Coin Tossing method. “Heads” is for Virtual Reality Group and “Tails” for Routine Physical Therapy Group, Blinding description: It will be a single blinded study blinding one of personnel of trial architecture i.e. assessors. Clinicians and patients are difficult to blind due to very nature of treatment protocol and study design.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebrovascular Accident (CVA) (Stroke).</hc_freetext>
      <i_freetext>Intervention 1: Virtual Reality group: The Wii is a home video game console released by Nintendo on November 19, 2006. As a seventh-generation console, the Wii competed with Microsoft's Xbox 360 and Sony's PlayStation 3. Nintendo states that its console targets a broader demographic than that of the two others. This device is the most suitable one to be utilized in this trial due to its control on three dimensional measurement. Patients in this group will get daily 60 minutes session, 3 days a week for 12 weeks. Intervention 2: Routine physical therapy group: These include proven methods such as sustained stretching program for hypo flexibility, strengthening program for extensiblity and balance training and coordination exercise to improve motor control and deficit. Also include motivational sessions over the time. Patient in this group will get 60 minutes session, 3 days a week for 12 weeks.</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 Its personal data of patients so can't share it with others</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naveed Anwar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>524/E Shah Rukn e alam, Multan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>60000</zip>
        <telephone>+92 42 36282885</telephone>
        <email>naveedanwar982@yahoo.com</email>
        <affiliation>Riphah International University, Lahore, Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naveed Anwar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>85, B Canal Gardens, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>60000</zip>
        <telephone>+92 42 36282885</telephone>
        <email>naveedanwar982@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients of both genders i.e. male and female
Age between 41-60 years
Unilateral involvement of extremity
First exposure of stoke episode either hemorrhagic or ischemic in origin and stroke evident by reports of CT Scan or MRI
At least a score of 2 on medical research council scale
Stable alert patient and able to follow the instructions of physical therapist</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Ischemic heart disease with unstable angina
History of seizers
Motor impairment such as neuropathy or Parkinson’s disease
Severe aphasia that can limit participation or feedback
Cognitive mental condition that can interfere with comprehension of commands</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebellar stroke syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Virtual Reality group: The Wii is a home video game console released by Nintendo on November 19, 2006. As a seventh-generation console, the Wii competed with Microsoft's Xbox 360 and Sony's PlayStation 3. Nintendo states that its console targets a broader demographic than that of the two others. This device is the most suitable one to be utilized in this trial due to its control on three dimensional measurement. Patients in this group will get daily 60 minutes session, 3 days a week for 12 weeks.</i_keyword>
      <i_keyword>Routine physical therapy group: These include proven methods such as sustained stretching program for hypo flexibility, strengthening program for extensiblity and balance training and coordination exercise to improve motor control and deficit. Also include motivational sessions over the time. Patient in this group will get 60 minutes session, 3 days a week for 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional independence. Timepoint: before intervention, 12 week after intervention, 24 week post intervention. Method of measurement: Strength testing on 0-5 scale and through Stroke impact scale questionnaire.</prim_outcome>
      <prim_outcome>Balance. Timepoint: before intervention, 12 week after intervention, 24 week post intervention. Method of measurement: Balance measurement through balance board and through Berg balance scale.</prim_outcome>
      <prim_outcome>Hand function. Timepoint: before intervention, 12 week after intervention, 24 week post intervention. Method of measurement: wolf motor hand function test.</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>university of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2639-12-11</approval_date>
        <contact_name>institutional Review Board</contact_name>
        <contact_address>1km, defence road, bhobattian chowk, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
