<?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>IRCT20230530058341N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-27</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Comparative effects of Carlo Perfetti Method and Proprioceptive Neuromuscular Facilitation technique on upper limb motor function in patients with subacute stroke</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of Carlo Perfetti Method and Proprioceptive Neuromuscular Facilitation technique on upper limb motor function in patients with subacute stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72354</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 with Lottery method and by the help of computerized generator, allocations will done to randomly allocate the participants in two groups, Blinding description: Participants will not know if they will be allocated in Carlo Perfetti Method group or in Proprioceptive Neuromuscular Facilitation Technique group for the Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Carlo Perfetti Method; As part of the treatment process, the patient will be blindfolded and the physical therapist will began to passively move the patient’s involved limb. The therapist will then ask the patient to sense and guess the movement of the limb that will be  performed by the therapist. To further enhance the rehabilitation process, the therapist will use a pattern of lines drawn on a page and will ask the patient to trace those lines with their hand, either actively or passively. This exercise will help to improve the patient's proprioception, which is their sense of body position and movement. By tracing the lines with their hand, the patient will be able to get a better sense of their limb's position and movement, which can be helpful in improving their coordination and motor function. Intervention 2: Intervention group: Proprioceptive Neuromuscular Facilitation Technique; In this group, the participants will be given the Rhythmic Initiation technique of Proprioceptive Neuromuscular Facilitation (PNF) technique. This technique will involve progressively transitioning from passive range of motion to active resisted movements of the limb. During the rehabilitation process, a series of movements will be performed, starting with voluntary relaxation and progressing to passive movements, active assisted and active resisted movements before finally transitioning to active movements. Verbal commands will be used to set the pace and rhythm of the movements, and light tracking will be incorporated during the resistive phase to facilitate movement. These exercises are design to improve motor function and range of motion and are customize to meet the specific needs of the patient. Rhythmic initiation helps in the initiation of the motion and improve the coordination and sense of the motion.</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>Hafsa Naz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P-526, St no 2, Aslam market, Hajveri town, millat road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38500</zip>
        <telephone>+92 41 8848211</telephone>
        <email>hafsanaz020@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hafsa Naz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P-526, St no 2, Aslam market, Hajveri town, millat road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38500</zip>
        <telephone>+92 41 8848211</telephone>
        <email>clinical.trainer.339@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range from 40 to 80 years
Both genders: male and female
Modified Ashworth scale 2
Mini-mental scale &gt; 24
Motricity index scale &lt; 99
MCA Stroke confirmed with MRI</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Already seeking any physiotherapy treatment
Having any wound or inflammation on upper extremity
Unstable medical condition
Any peripheral nerve injury
Before stroke any upper limb musculoskeletal functional impairments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z82.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Family history of stroke</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: Carlo Perfetti Method; As part of the treatment process, the patient will be blindfolded and the physical therapist will began to passively move the patient’s involved limb. The therapist will then ask the patient to sense and guess the movement of the limb that will be  performed by the therapist. To further enhance the rehabilitation process, the therapist will use a pattern of lines drawn on a page and will ask the patient to trace those lines with their hand, either actively or passively. This exercise will help to improve the patient's proprioception, which is their sense of body position and movement. By tracing the lines with their hand, the patient will be able to get a better sense of their limb's position and movement, which can be helpful in improving their coordination and motor function.</i_keyword>
      <i_keyword>Intervention group: Proprioceptive Neuromuscular Facilitation Technique; In this group, the participants will be given the Rhythmic Initiation technique of Proprioceptive Neuromuscular Facilitation (PNF) technique. This technique will involve progressively transitioning from passive range of motion to active resisted movements of the limb. During the rehabilitation process, a series of movements will be performed, starting with voluntary relaxation and progressing to passive movements, active assisted and active resisted movements before finally transitioning to active movements. Verbal commands will be used to set the pace and rhythm of the movements, and light tracking will be incorporated during the resistive phase to facilitate movement. These exercises are design to improve motor function and range of motion and are customize to meet the specific needs of the patient. Rhythmic initiation helps in the initiation of the motion and improve the coordination and sense of the motion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spasticity. Timepoint: At baseline, after second week of treatment, after fourth week of treatment, after sixth week of treatment, after eighth week of treatment and after tenth week of treatment. Method of measurement: Modified Ashworth Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Motor function of upper extremity. Timepoint: At baseline, after second week of treatment, after fourth week of treatment, after sixth week of treatment, after eighth week of treatment and after tenth week of treatment. Method of measurement: Motricity Index Scale.</sec_outcome>
      <sec_outcome>Arm motor performance and movement quality. Timepoint: At baseline, after second week of treatment, after fourth week of treatment, after sixth week of treatment, after eighth week of treatment and after tenth week of treatment. Method of measurement: Motor Evaluation Scale for Upper Extremity.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-24</approval_date>
        <contact_name>Ethics Committee of The University of Faisalabad</contact_name>
        <contact_address>West Canal Road, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
