<?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>IRCT20240503061639N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-13</date_registration>
      <primary_sponsor>Riphah international university</primary_sponsor>
      <public_title>Comparative effects of modified otago exercise program(MOEP) and perturbation-based balance training (PBT)on reactive postural control and balance in patients with sub-acute stroke</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of modified otago exercise program(MOEP) and perturbation-based balance training(PBT)on reactive postural control and balance in patients with sub-acute stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76624</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through simple random sampling using lottery method. this will be cluster randomization because we had large sample size for two intervention groups with 32 patients in each group. In lottery method , we will assigned a number to patient as 1,23...…64, after which we select a random numbers for each interventions groups, so first 32 selected patients will receive modified otago exercise program and next 32 will receive perturbation based balance training, Blinding description: Participants are blind in my study, because they are divided into two intervention groups without knowing it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sub-acute Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention no 1 will be modified otago exercise program and routine physical therapy treatment. Participants will engage in 20 minute of routine physical therapy which includes range of motion and isometric exercises and 60 minutes of moderate-intensity otago exercises. The modified otago exercises consists of 17 strength(with 10 repetitions, with and without support) and balance exercises and a walking program, 15 minutes walking before and after strength and balance exercises. Balance exercises will be knee bends, backwards walking with or without assistive device, walking and turning around with or without assistive device, sideways walking with or without assistive device, tandem stance (heel toe stand) with or without assistive device , tandem walk (heel toe walk) with or without assistive device , one leg stand with or without assistive device , heel walking with or without assistive device , toe walk with or without assistive device , heel toe walking backwards with or without assistive device, sit to stand with or without assistive device , stair walking with or without assistive device. Intervention program will be continued for 8 weeks, and 3 times a week. Assistive devices will be used like canes etc. Intervention 2: Intervention group 2 will be Perturbation based balance training and  routine physical therapy treatment. Participants will engage in 20 minute of routine physical therapy which includes range of motion and isometric exercises and 60 minutes of perturbation based balance training which includes double-leg foam balance activity, tilt board training and roller board and platform perturbations. Devices used are knee cushion, foam, tilt board and platform. Intervention program will be continued for 8 weeks, and 3 times a week. Assistive devices will be used like canes etc.</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 I will plan it after my thesis finalization so that there will be na chance of error</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rida Zahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street no 5 New Islam Pura ,Toba Tek Singh,Pakistan</address>
        <city>Toba Tek Singh</city>
        <country1>Pakistan</country1>
        <zip>36050</zip>
        <telephone>+92 325 0405631</telephone>
        <email>ridazahid173@gmail.com</email>
        <affiliation>Riphah international university Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rida Zahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street no 5 New Islam Pura ,Toba Tek Singh,Pakistan</address>
        <city>Toba Tek Singh</city>
        <country1>Pakistan</country1>
        <zip>36050</zip>
        <telephone>+92 325 0405631</telephone>
        <email>ridazahid173@gmail.com</email>
        <affiliation>Riphah international university Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Sub-acute stroke patients
Survivors of ischemic stroke
Subjects should have stable condition after the stoke incidence
Tolerance of balance and gait tasks without fatigue
Both genders can participate in the study
Age from 50 to 70yearsPatient who can follow written, verbal directions and demonstration</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any other neurological conditions (Brain Injury, Multiple Sclerosis, Parkinson’s disease and Vestibular Disorders).
Subjects with diagnosed peripheral neuropathy
Patient with visual and vestibular impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z82.3 G46.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Family history of stroke, Cerebellar stroke syndrome , Brain stem stroke syndrome, Cerebrovascular disease, unspecified, Sequelae of cerebrovascular disease, Sequelae of stroke, not specified as haemorrhage or infarction,</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention no 1 will be modified otago exercise program and routine physical therapy treatment. Participants will engage in 20 minute of routine physical therapy which includes range of motion and isometric exercises and 60 minutes of moderate-intensity otago exercises. The modified otago exercises consists of 17 strength(with 10 repetitions, with and without support) and balance exercises and a walking program, 15 minutes walking before and after strength and balance exercises. Balance exercises will be knee bends, backwards walking with or without assistive device, walking and turning around with or without assistive device, sideways walking with or without assistive device, tandem stance (heel toe stand) with or without assistive device , tandem walk (heel toe walk) with or without assistive device , one leg stand with or without assistive device , heel walking with or without assistive device , toe walk with or without assistive device , heel toe walking backwards with or without assistive device, sit to stand with or without assistive device , stair walking with or without assistive device. Intervention program will be continued for 8 weeks, and 3 times a week. Assistive devices will be used like canes etc.</i_keyword>
      <i_keyword>Intervention group 2 will be Perturbation based balance training and  routine physical therapy treatment. Participants will engage in 20 minute of routine physical therapy which includes range of motion and isometric exercises and 60 minutes of perturbation based balance training which includes double-leg foam balance activity, tilt board training and roller board and platform perturbations. Devices used are knee cushion, foam, tilt board and platform. Intervention program will be continued for 8 weeks, and 3 times a week. Assistive devices will be used like canes etc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reactive postural control. Timepoint: Before intervention, after 4 weeks of intervention program and 8 weeks after completion of intervention program. Method of measurement: Mini- bestest scale will be used for assessment of reactive postural control.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance. Timepoint: on start of treatment, after 4 weeks of treatment and 8 weeks after completion of intervention program. Method of measurement: Berg balance scale will be used for the assessment of balance.</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>Rida zahid</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-29</approval_date>
        <contact_name>Ethics committee of Riphah International University</contact_name>
        <contact_address>Raza street 25, Bhabra' block M, Gulberg 3, Lahore, Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
