<?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>IRCT20201101049221N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-24</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effects of Proprioceptive Neuromuscular Facilitation on balance and gait in chronic stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of gait training with and without Proprioceptive Neuromuscular Facilitation on balance and gait in chronic stroke patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52028</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The study is double blinded randomized control trial. two groups are taken, control group and experimental group for comparison, Randomization description: randomization was done by lottery method, Blinding description: Participants and Outcome evaluators were unaware of group allocation.After randomization, study participants were only informed about their allocated exercise program, they remained unaware of the interventions in the other group. Information about the details of both programs was not provided except for similar exercises among both groups. Researchers who assessed outcomes or involved in data analyses will be masked to group allocation.Moreover, if two or more study participants were in the clinic at the same time, they were assigned to different treatment areas without any opportunity to observe each other or their treatment times were rearranged to prevent unintended crossover.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group in which routine physical therapy was performed for 20 minutes and PNF with gait training for 30 minutes (total 50 minutes session). Routine physical therapy involved muscle strengthening exercises, range of motion exercises and stretching exercises up to patient’s tolerance based gait training involved PNF pelvic patterns, PNF lower extremity D1 Flexion and PNF lower extremity D1 extension, each exercise was repeated 10 to 20 times or up to patient’s tolerance, progressed from rhythmic initiation to stabilizing reversals and then followed by dynamic reversals up to 4th week of treatment session. Other exercises involved pelvic bridging, rolling, sitting and standing exercises and walking practice in parallel bars and treadmill training up to patients tolerance.The treatment was provided at rehabilitation clinic 3 days per week on alternate basis, for 6 weeks (18 sessions). parallel bars, couch, standard chair and treadmill were used during treatment. Intervention 2: Control group had a treatment session of 40 minutes, 20 minutes of routine physical therapy as that in experimental group that included muscle strengthening exercises, range of motion exercises and stretching exercises up to patient’s tolerance and 20 minutes of gait training alone, that included pelvic rolling, bridging, sitting and standing exercises and walking practice in parallel bars and treadmill training up to patients tolerance.  The treatment was provided at rehabilitation clinic 3 days per week on alternate basis, for 6 weeks (18 sessions).parallel bars, couch, standard chair and treadmill were used during treatment.</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 Data may be available after completion and publication of clinical trial</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ashfaq Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 Km, Defence Road Campus,Bhobatian Chowk, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>75500</zip>
        <telephone>+92 56 3785097</telephone>
        <email>momna2april@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ashfaq Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km, Defence road, Bhobatian chowk Lahore, Pakistsn</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>75500</zip>
        <telephone>+92 56 3785097</telephone>
        <email>momna2april@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hemiplegic patients having single episode of hemorrhagic or ischemic stroke
Participants who are more than 6 months post stroke
Having Mini Mental Status Exam greater than 24
Patients who are able to walk with or without support for 10 m
Patients having no orthopedic injuries</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>participants with severe spasticity (modified ashworth scale grade≥3) or severe flaccidity in lower limbs and upper limbs
participants having visual and auditory dysfunctions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I67</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other 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>Experimental group in which routine physical therapy was performed for 20 minutes and PNF with gait training for 30 minutes (total 50 minutes session). Routine physical therapy involved muscle strengthening exercises, range of motion exercises and stretching exercises up to patient’s tolerance based gait training involved PNF pelvic patterns, PNF lower extremity D1 Flexion and PNF lower extremity D1 extension, each exercise was repeated 10 to 20 times or up to patient’s tolerance, progressed from rhythmic initiation to stabilizing reversals and then followed by dynamic reversals up to 4th week of treatment session. Other exercises involved pelvic bridging, rolling, sitting and standing exercises and walking practice in parallel bars and treadmill training up to patients tolerance.The treatment was provided at rehabilitation clinic 3 days per week on alternate basis, for 6 weeks (18 sessions). parallel bars, couch, standard chair and treadmill were used during treatment.</i_keyword>
      <i_keyword>Control group had a treatment session of 40 minutes, 20 minutes of routine physical therapy as that in experimental group that included muscle strengthening exercises, range of motion exercises and stretching exercises up to patient’s tolerance and 20 minutes of gait training alone, that included pelvic rolling, bridging, sitting and standing exercises and walking practice in parallel bars and treadmill training up to patients tolerance.  The treatment was provided at rehabilitation clinic 3 days per week on alternate basis, for 6 weeks (18 sessions).parallel bars, couch, standard chair and treadmill were used during treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balancing capability. Timepoint: before intervention and six weeks after intervention. Method of measurement: Berg Balance Scale.</prim_outcome>
      <prim_outcome>Gait parameters. Timepoint: before interventions and six weeks after interventions. Method of measurement: GAITRite platinum.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-05</approval_date>
        <contact_name>Institutional Review Board of The University of Lahore</contact_name>
        <contact_address>207 B block, AWT phase 2, Lahore , Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
