<?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>IRCT20211022052835N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-03</date_registration>
      <primary_sponsor>Shifa Tameer-e-Millat University</primary_sponsor>
      <public_title>A comparative study to assess the effect of balance training with and without taping on mobility and balance in stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study to assess the effect of balance training with and without taping on mobility and balance in stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69556</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: N/A, Randomization description: In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study. After taking consent from the participants for their participation in the study, the therapist opens the envelop and give the respective protocol to the individual. The study is single blinded as participants is not aware of the intervention group they are placed in. Participants will be placed either in to the experimental group 1 (Balance training with taping) or control group 2 (Balance training without taping) keeping the process completely randomized ,sealed envelope method will be used, Blinding description: Prior to collecting data,  participants would be informed about both the treatment techniques used in both groups; experimental group A (Balance training with taping) and control group B (Balance training without taping). Further they are informed that you will get one of these treatment depending upon the group written on the card inside the envelop you choose. The group A or B belongs to which way of treatment is known to therapist but the patient doesn't know about it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemiparesis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group A: Group A would receive Balance training with taping. There would be 3 sessions per week for 4 weeks. Session would be comprised of 20 minutes with 5 minutes of warm and 5 minutes of cool down before and after the session. Experimental group (taping group), for taping with balance training, kinesio tape will be used for ankle taping. Kinesio tape is used to stabilize the ankle joint during static standing or walking in stroke patients. In this study, the tape will be attached to the peroneus tertius, peroneus longus, tibialis anterior, and extensor hallucis longus, which are used widely for ankle joint stability in stroke patients. With kinesio tape attached to the four muscles, each participant will be given balance training for 20 minutes. Balance training plan: (1) 5 minutes warm-up, (2) 10 minutes static balance exercises, such as Squats (two leg stance), One leg stance, (3) 10 minutes dynamic balance exercises, such as Jogging end to end, Sideways walking or running with crossovers, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, and (4) 5 minutes of cool-down. Intervention 2: Intervention Group B: Group B would receive Balance training without taping. There would be 3 sessions per week for 4 weeks. Session would be comprised of 20 minutes with 5 minutes of warm and 5 minutes of cool down before and after the session. Balance training plan: (1) 5 minutes warm-up, (2) 10 minutes static balance exercises, such as Squats (two leg stance), One leg stance, (3) 10 minutes dynamic balance exercises, such as Jogging end to end, Sideways walking or running with crossovers, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, and (4) 5 minutes of cool-down. These are traditional balance exercise. The treatment duration for the control group will be 20 minutes/3 times a 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fouzia Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 332 7120385</telephone>
        <email>fouzia_dpt.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer-e-Millat University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fouzia Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 332 7120385</telephone>
        <email>fouzia_dpt.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer-e-Millat University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants of both genders with age more than 35 year will be enrolled.
Participants those with hemiparesis with onset more than three months of stroke onset and less than one and a half year.
A score of 24 or higher on the MMSE, those who can walk more than 10 m independently with or without a walking aid.
Those who are having spastic paralysis of lower limb, those who understand the purpose of the study and provided written consent form.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participant those with a history of surgery on the lower extremities.
High skin sensitivity or skin diseases.
Those who complained of pain during dorsiflexion of the ankle joint, and those with a modified Ashworth Scale &gt;2.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>G46</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 A: Group A would receive Balance training with taping. There would be 3 sessions per week for 4 weeks. Session would be comprised of 20 minutes with 5 minutes of warm and 5 minutes of cool down before and after the session. Experimental group (taping group), for taping with balance training, kinesio tape will be used for ankle taping. Kinesio tape is used to stabilize the ankle joint during static standing or walking in stroke patients. In this study, the tape will be attached to the peroneus tertius, peroneus longus, tibialis anterior, and extensor hallucis longus, which are used widely for ankle joint stability in stroke patients. With kinesio tape attached to the four muscles, each participant will be given balance training for 20 minutes. Balance training plan: (1) 5 minutes warm-up, (2) 10 minutes static balance exercises, such as Squats (two leg stance), One leg stance, (3) 10 minutes dynamic balance exercises, such as Jogging end to end, Sideways walking or running with crossovers, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, and (4) 5 minutes of cool-down.</i_keyword>
      <i_keyword>Intervention Group B: Group B would receive Balance training without taping. There would be 3 sessions per week for 4 weeks. Session would be comprised of 20 minutes with 5 minutes of warm and 5 minutes of cool down before and after the session. Balance training plan: (1) 5 minutes warm-up, (2) 10 minutes static balance exercises, such as Squats (two leg stance), One leg stance, (3) 10 minutes dynamic balance exercises, such as Jogging end to end, Sideways walking or running with crossovers, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, and (4) 5 minutes of cool-down. These are traditional balance exercise. The treatment duration for the control group will be 20 minutes/3 times a week for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Pre intervention at 0-week, and Post Intervention data after 4 weeks will be taken. Method of measurement: Ten meter walk test, Berg Balance Scale, Timed up and go test, Six Minute Walk Test.</prim_outcome>
      <prim_outcome>•	Mobility. Timepoint: Pre intervention at 0-week, and Post Intervention data after 4 weeks will be taken. Method of measurement: Ten meter walk test, Berg Balance Scale, Timed up and go test, Six Minute Walk Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To compare the effect of balance training with and without taping on mobility and balance in stroke patients. Timepoint: Pre Intervention at 0 week, and Post Intervention data after 4 weeks will be taken. Method of measurement: Ten meter walk test, Berg Balance Scale, Timed up and go test, Six Minute Walk Test.</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>Shifa Tameer-e-Millat University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-04</approval_date>
        <contact_name>Institutional review board and ethical committee and ethical committee of shifa tameer-e-millat univ</contact_name>
        <contact_address>Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad Islamabad Islamabad Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
