<?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>IRCT20160430027676N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-30</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Proprioceptive Neuromuscular Facilitation (PNF) on Quality of Life (QOL)</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Proprioceptive Neuromuscular Facilitation (PNF) on Quality of Life (QOL) of Patients with Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33406</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Cerebrovascular Accident.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Proprioceptive neuromuscular facilitation exercise program was performed for 8 weeks and two sessions each week for 30-45 minutes (16 sessions within 2 months) based on the protocol and the relevant instruction in the intervention group. In this study, the pattern of motion of the arm (Upper Extremity ) and hip movement patterns (lower Extremity) are used.Patterns of the arm joint (upper extremity): D1 flexion pattern: Flexion, abduction, External rotation (elbow flexed and elbow extended). D1 extension pattern: Extension, adduction, internal rotation (elbow flexed and elbow extended). D2 flexion pattern: flexion, adduction, external rotation (elbow flexed and elbow extended). D2 extension pattern: extension, abduction, internal rotation (elbow flexed and elbow extended). Patterns of knee joint(lower extremity): D1 flexion pattern: Flexion, abduction, internal rotation (knee flexed and knee extended). D1 extension pattern: Extension, adduction, external rotation (knee flexed and knee extended). D2 flexion pattern: Flexion, adduction, external rotation (knee flexed and knee extended). D2 extension pattern: Extension, abduction, internal rotation (knee flexed and knee extended). The therapist first places the member in the position according to the three axes of motion. In this case, the muscles are drawn as far as possible (not up to the latest range of motion). The first step: A passive stretching or active within 10 to 20 seconds actions and target muscle or muscles gently used gradually the end range of motion.This situation is maintained for a while. Second stage: Immediately or after a break of about 2 to 3 seconds of contraction unlike the therapist takes place. The contract period is typically 3 to 6 seconds. Third stage: Immediately or after a pause of about 2 to 3 seconds again to reach the target muscle or muscle twitching find a new point of range of motion. Immediately and 4 weeks after the last session of the exercise, the quality of life of the patients will be measured. Intervention 2: Control group: Before intervention, immediately after the intervention and 4 weeks after the end of the intervention,the quality of life will be measured using the relevant questionnaire.There will be no intervention in the control group.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parandvar Yaghoub</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of ICU, Martyr Dr.Beheshti hospital , Martyr Mohammad Montazeri street, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591794857</zip>
        <telephone>+98 74 3322 4721</telephone>
        <email>y.parandvar@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>parandvar yaghoub</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of ICU, Martyr Dr.Beheshti hospital , Martyr Mohammad Montazeri street, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591794857</zip>
        <telephone>+98 74 3322 4721</telephone>
        <email>y.parandvar@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Personal and informed consent to attend the study
Over 4 months to 2 years after stroke
Definitive diagnosis of stroke by a neurologist
Age more than 60 years to 90 years
Once affected by stroke
The absence of spinal cord lesions
Failure to receive Proprioceptive Neuromuscular Facilitation Technique from 6 months ago
Lack of other chronic diseases, such as orthopedic and neurological diseases
Ability to communicate and answer Persian questions
Residence in Yasuj</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disruption of the cognitive, alert and mental state of the patient
Age more than 90 years old</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(I69.4)</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>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 group: Proprioceptive neuromuscular facilitation exercise program was performed for 8 weeks and two sessions each week for 30-45 minutes (16 sessions within 2 months) based on the protocol and the relevant instruction in the intervention group. In this study, the pattern of motion of the arm (Upper Extremity ) and hip movement patterns (lower Extremity) are used.Patterns of the arm joint (upper extremity): D1 flexion pattern: Flexion, abduction, External rotation (elbow flexed and elbow extended). D1 extension pattern: Extension, adduction, internal rotation (elbow flexed and elbow extended). D2 flexion pattern: flexion, adduction, external rotation (elbow flexed and elbow extended). D2 extension pattern: extension, abduction, internal rotation (elbow flexed and elbow extended). Patterns of knee joint(lower extremity): D1 flexion pattern: Flexion, abduction, internal rotation (knee flexed and knee extended). D1 extension pattern: Extension, adduction, external rotation (knee flexed and knee extended). D2 flexion pattern: Flexion, adduction, external rotation (knee flexed and knee extended). D2 extension pattern: Extension, abduction, internal rotation (knee flexed and knee extended). The therapist first places the member in the position according to the three axes of motion. In this case, the muscles are drawn as far as possible (not up to the latest range of motion). The first step: A passive stretching or active within 10 to 20 seconds actions and target muscle or muscles gently used gradually the end range of motion.This situation is maintained for a while. Second stage: Immediately or after a break of about 2 to 3 seconds of contraction unlike the therapist takes place. The contract period is typically 3 to 6 seconds. Third stage: Immediately or after a pause of about 2 to 3 seconds again to reach the target muscle or muscle twitching find a new point of range of motion. Immediately and 4 weeks after the last session of the exercise, the quality of life of the patients will be measured.</i_keyword>
      <i_keyword>Control group: Before intervention, immediately after the intervention and 4 weeks after the end of the intervention,the quality of life will be measured using the relevant questionnaire.There will be no intervention in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life for stroke patients. Timepoint: Before the intervention, Immediately after the intervention, 4 week after the intervention. Method of measurement: World Health Organization Quality of Life Short Form questioner.</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>Yasouj University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-04</approval_date>
        <contact_name>Ethics Committee on Research, Yasuj University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor of research and technology, Yasuj University of Medical Sciences, Motahari Blvd,Yasouj, Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
