<?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>IRCT20230716058795N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-23</date_registration>
      <primary_sponsor>The University Of Faisalabad | TUF University</primary_sponsor>
      <public_title>Comparing the effectiveness of facilitated electric stimulation of two alternating patterns on lower extremity function in hemiplegic Stroke patients</public_title>
      <acronym>Functional Gait Assessment (FGA) Modified Ashworth scale (MAS) Facilitated/functional electric stimulation (FES) Range of Motion (ROM)           Anterior pelvic tilt (APT)          Posterior pelvic tilt (PPT)                 Total pelvic tilt (TPT)       </acronym>
      <scientific_title>COMPARING THE EFFECTIVENESS OF FACILITATED ELECTRIC  STIMULATION OF TWO ALTERNATING PATTERNS ON LOWER  EXTREMITY FUNCTION IN HEMIPLEGIC STROKE PATIENTS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72604</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: purposive sampling tecjnique, Randomization description: Randomized through sealed envelope, Blinding description: Participants and data analyzer.</study_design>
      <phase>1-2</phase>
      <hc_freetext>HEMIPLEGIC STROKE.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Abdominals cross Hamstrings and additional conventional exercises 3 days per week with 30 minutes. Additional conventional exercises will include lower limb joint mobilizations(including hips, knees, ankles and feet), stretching of lower extremity, and ROMS.   . Intervention 2: Intervention group: : Lower back cross Quads and additional conventional exercises 3 days per week with 30 minutes stimulation each session. Additional conventional exercises will include lower limb joint mobilizations (including hips, knees, ankles and feet), stretching of lower extremity, and ROMs.</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 patient confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marium Zafar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>TUF University canal campus,Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 2409608</telephone>
        <email>marium.zafar@tuf.edu.pk</email>
        <affiliation>The University Of Faisalabad | TUF University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marium Zafar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University Of Faisalabad | TUF University canal campus Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 2409608</telephone>
        <email>marium.zafar@tuf.edu.pk</email>
        <affiliation>The University Of Faisalabad | TUF University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>• All men and women will be included in study.
• Hemiplegic stroke patients will be included in study
• Age between forty five to sixty years old will be included in study.
• Patient with static and dynamic sitting balance will be included.
• Patients with static standing balance will be included in this study.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>All patients had imaging tests to rule out their diagnosis for stroke during the acute stage.• People who frequently have strokes.
Patients with peripheral or orthopedic neuropathy, substantial vision field defects, or hemi neglect issues were not included.
Hemiplegic stroke not due to a stroke but due to another neurological condition.• Poorly controlled epilepsy:  When medicine is being used to treat epilepsy and there haven't been any seizures in a while
People who frequently have strokes
FES may be used.
Pregnancy: The effects of FES on the growing child during pregnancy are unknown.
Heart pacemakers: Any electrical activity could interfere with the electrical impulses that the pacemakers send out, rendering them inoperative.
Patients with malignant tumors should not be considered since the electrical stimulation's potential to increase local blood flow could promote the growth of the tumor.
Exposed metal: In patients with exposed orthopedic metalwork, electrical stimulation in the afflicted area should be avoided
Suspected, recognized, or uncontrolled cardiovascular conditions: The circulatory demand brought on by the FES-induced muscular contractions may necessitate taking extra precautions both before and during stimulation delivery.
Neurological problems other than ischemic brain injury or hemorrhage that can result in hemiplegic stroke.
If the muscles around a fracture that hasn't healed up contract, the fracture may get displaced.
People who have cerebellar, brain stem, or bilateral hemisphere lesions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I69.359</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemiplegia and hemiparesis following cerebral infarction 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: Abdominals cross Hamstrings and additional conventional exercises 3 days per week with 30 minutes. Additional conventional exercises will include lower limb joint mobilizations(including hips, knees, ankles and feet), stretching of lower extremity, and ROMS.   .</i_keyword>
      <i_keyword>Intervention group: : Lower back cross Quads and additional conventional exercises 3 days per week with 30 minutes stimulation each session. Additional conventional exercises will include lower limb joint mobilizations (including hips, knees, ankles and feet), stretching of lower extremity, and ROMs</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pelvic tilt. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Inclinometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cadence. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Carbon Foot Prints.</sec_outcome>
      <sec_outcome>Range of motion of lower extremity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Universal Goniometer.</sec_outcome>
      <sec_outcome>Spasticity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Modified Ashworth Scale.</sec_outcome>
      <sec_outcome>Gait analysis. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Functional Gait Analysis.</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 Faisalabad | TUF University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-03</approval_date>
        <contact_name>The University of Faisalabad</contact_name>
        <contact_address>University of Faisalabad, canal road campus, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
