<?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>IRCT20210507051205N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-15</date_registration>
      <primary_sponsor>Madinah Teaching Hospital Faisalabad</primary_sponsor>
      <public_title>COMPARATIVE EFFECTS OF BACKWARD WALKING TRAINING AND STANDING BALANCE TRAINING ON WALKING SPEED AND BALANCE IN PATIENTS WITH SUBACUTE STROKE</public_title>
      <acronym></acronym>
      <scientific_title>COMPARATIVE EFFECTS OF BACKWARD WALKING TRAINING AND STANDING BALANCE TRAINING ON WALKING SPEED AND BALANCE IN PATIENTS WITH SUBACUTE STROKE</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>61</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57056</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Randomization was done using an online random number generator, randomizer.org.  Website determined 2 sets (A and B). Set A was BWT group and set B was SBT group. The numbers from 1-70 were selected (The sample size was 70, 35 in each group). Randomizer generated the numbers for each group (A or B) and patients were allocated based on that numbers, Blinding description: The participants had no information about the treatment given in both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Subacute Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A:Group A participants received the task oriented training (grasping objects and CIMT) combined with backward walking training. The participants were treated 60 minutes, 3 times per week for 4 weeks. Intervention 2: Intervention group: Group B:Group B participants received the task oriented training (grasping objects and CIMT) combined with standing balance training. The participants were treated 60 minutes, 3 times per week for 4 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The primary and secondary outcome measure data will be shared and no further detail regarding patients personal information will be provided

When:
Starting in January 2022

To whom:
Researchers , scholars, physiotherapist

Conditions:
none

Where to obtain:
Direct contact with Responsible

How to obtain:
Access as per policy

Comments:
none</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Umer Shabbir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West canal road faisal town</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8750971</telephone>
        <email>muhammad.umer.shabbir@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsin Hussain PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West canal road faisal town</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8750971</telephone>
        <email>m.mohsinhussain@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of first stroke in previous 45 days,
Patients older than 20 years and less than 50 years,
Able to maintain upright standing posture with moderate assistance,
Anticipated inpatient rehabilitation length of stay 2 to 3 weeks,
Anticipated remaining in the geographic area for the study duration,
Vision within functional limits (considered enough for gait training)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of significant balance impairment, defined by Berg Balance Scale (BBS) score greater than 45/56,
Lower extremity joint or weight-bearing pain,
Other neurological diagnoses,
Inability to follow 2-step command,
History of Contraversive pushing syndrome,
History of Cerebellar stroke.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I69.869</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other paralytic syndrome following other cerebrovascular disease affecting unspecified side</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: Group A:Group A participants received the task oriented training (grasping objects and CIMT) combined with backward walking training. The participants were treated 60 minutes, 3 times per week for 4 weeks.</i_keyword>
      <i_keyword>Intervention group: Group B:Group B participants received the task oriented training (grasping objects and CIMT) combined with standing balance training. The participants were treated 60 minutes, 3 times per week for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Berg balance scale. Timepoint: baseline, after 3 weeks and at the end of 6th week. Method of measurement: The 14-item scale was used to assess the static and dynamic standing balance, sitting, standing up, and transfer ability. This scale has a great reliability, validity and it has been in use for years for assessing the balance in post-stroke patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>6-Meter walk test. Timepoint: at baseline, at the end of 2nd week and at the end of 4th week. Method of measurement: The 6-Meter Walk Test was used to evaluate gait speed, which helped to explain responsiveness in stroke patients. A stopwatch was used to record the amount of time it took to walk. Participants covered the distance twice at their own pace to determine their average gait speed. If balance aid was needed, it was given, but no help with the lower extremities was offered. At each research time point, the evaluation was performed with the least orthotic and restrictive assistive device possible.</sec_outcome>
      <sec_outcome>3-meter backward walk test. Timepoint: at baseline, at the end of 2nd week and at the end of 4th week. Method of measurement: The 3-Meter Backward Walk Test was used to determine backward walking speed. A timer was used to record the time it took to walk backward 3 meters. Participants covered the distance twice at their own pace to determine their average gait speed. If balance aid was needed, it was given, but no help with the lower extremities was offered. At each research time point, the evaluation was performed using the least orthotic and restrictive assistive device.</sec_outcome>
      <sec_outcome>Berg balance scale. Timepoint: at baseline, at the end of 2nd week and at the end of 4th week. Method of measurement: This 14-item scale assessed the static and dynamic standing balance, sitting, standing up, and transfer ability. This scale has a great reliability, validity and it has been in use for years for assessing the balance in post-stroke patients. This scale measured the questions on the basis of Likert scale system and the score ranged from 0-56 and the scoring reference is as:                          41-56 =  independent    21-40 =  walking with assistance   0 –20 =  wheelchair bound.</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>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-29</approval_date>
        <contact_name>UIPT Ethical Review Committee</contact_name>
        <contact_address>Defense road bhuptian chowk Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
