<?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>IRCT20201021049094N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-10</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effectiveness of virtual rehabilitation versus therapeutic exercises in the balance training of lower limb among post-stroke patients</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Effectiveness of virtual rehabilitation versus therapeutic exercises in the balance training of lower limb among post-stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization by lottery method. Allocation concealment through a sealed envelope. In a bowl, we put closed slips of groups A and B. Participants fulfilling inclusion criteria randomly picked up groups and then allocated them through a sealed envelope, Blinding description: Patient was not aware of the group treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke: Stroke is a disease of the central nervous system produced by obstruction of the cerebral blood ﬂow due to the occlusion (ischemic stroke) or rupture (hemorrhagic stroke) of a cerebral blood vessel. Aﬀerent and eﬀerent neural pathways are aﬀected, and motor, sensitive and cognitive capabilities become impaired as a result of brain cortex injury. Motor and cognitive damage reduce their functional potential and independence..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They group played video games using X-box and Kinect connected to the laptop. This group performed training for 35-40 minutes, 3 days/week for a total of 6 weeks times duration. The repetitions will increase according to the performance of the patient. Games were started from the basic level and the level was increased according to the patient’s performance. The training was done under the supervision of a trained physiotherapist to avoid any hazards. Intervention 2: Control group: They performed balance exercises such as the tandem walk, heel stand, forward striding, side step, single leg stand, and double leg stand for 35-40 minutes, 3 days/week for a total of 6 weeks times duration. The exercises were done under the supervision of the Physiotherapist.</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 pending by supervisor</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hana Pervaiz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohala kaira ward no.1 house no.B-115, Lalamusa Pakistan</address>
        <city>lalamusa</city>
        <country1>Pakistan</country1>
        <zip>50200</zip>
        <telephone>+92 304 0907209</telephone>
        <email>hanapervaiz7@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>hana pervaiz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohala kaira ward no.1 house no.B-115, Lalamusa Pakistan</address>
        <city>lalamusa</city>
        <country1>Pakistan</country1>
        <zip>50200</zip>
        <telephone>+92 304 0907209</telephone>
        <email>hanapervaiz7@gmail.com</email>
        <affiliation>The university of lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 35 – 55 years.
Potential participants with 3 months post-stroke lower limb movement difficulties.
Ability to stand up with or without assistive devices and patients with stable vital signs.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion Criteria: Subjects with severe hypertension.
Patients with a history of Deep venous thrombosis or Pulmonary embolism
Lower limb amputation
Auditory or visual dysfunction
If the patient has severe receptive or expressive aphasia that affects the ability to communicate with or give consent
Significant cognitive impairment  such  as the ability to follow two-level commands</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: They group played video games using X-box and Kinect connected to the laptop. This group performed training for 35-40 minutes, 3 days/week for a total of 6 weeks times duration. The repetitions will increase according to the performance of the patient. Games were started from the basic level and the level was increased according to the patient’s performance. The training was done under the supervision of a trained physiotherapist to avoid any hazards.</i_keyword>
      <i_keyword>Control group: They performed balance exercises such as the tandem walk, heel stand, forward striding, side step, single leg stand, and double leg stand for 35-40 minutes, 3 days/week for a total of 6 weeks times duration. The exercises were done under the supervision of the Physiotherapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before intervention, Mid intervention and After intervention. Method of measurement: Berg Balance Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of Motion. Timepoint: Before intervention, Mid intervention and after intervention. Method of measurement: Through Goniometer.</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>Self</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-18</approval_date>
        <contact_name>University of Lahore, Gujrat Campus</contact_name>
        <contact_address>University of Lahore, Gujrat campus near chenab river Gujrat Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
