<?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>IRCT20200620047848N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-01</date_registration>
      <primary_sponsor>Ripah International University</primary_sponsor>
      <public_title>Comparison of effects of Same Arm Movement Therapy (SAME) Vs Constraint Induced Movement Therapy (CIMT) to improve upper-limb function in chronic Stroke</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effects of Same Arm Movement Therapy (SAME) Vs Constraint Induced Movement Therapy (CIMT) to improve upper-limb function in chronic Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49054</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Non- Probability Convenient Sampling will be used to recruit the individuals for the study and then randomization will be done by lottery method to divide the individuals into 2 treatment groups. Sealed envelope will be used for allocation concealment, Randomization description: Randomization by lottery method. Allocation concealment through sealed envelope, Blinding description: participant will be blinded.</study_design>
      <phase>2</phase>
      <hc_freetext>Chronic stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: SAME Therapy treatment protocols consist of 8 weeks of mental rehearsals of upper limb movements during 45-mints supervised sessions three times a week and structural independent sessions twice a week. Intervention 2: Intervention group B: CIMT treatment protocol consists of 8 weeks of daily intensive training of the affected extremity for 2 hours per day, 5 days per week, and 8 weeks in association with restriction of the non-affected extremity for 10 hours a day.</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 decision and information decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alina Shaukat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54770</zip>
        <telephone>0432172454</telephone>
        <email>alinashaukat07@gmail.com</email>
        <affiliation>Ripah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alina Shaukat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54770</zip>
        <telephone>+92 42 32172454</telephone>
        <email>alinashaukat07@gmail.com</email>
        <affiliation>Ripah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmed infarct or Hemorrhage by a neurologist using either MRI or CT scan
Age between 30-65
History of stroke 1–6 months prior to participation in the project
Patients who provided consents to participate in the study
Proper balance and safety while wearing the restraint</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>They were discharged from hospital within 1 week
Patients participating in any experimental rehabilitation on drug studies
Patients with implants such as Neuro stimulator containing electric circurity and implants generating electric sign
Patients with anxiety and claustrophobia with diagnosed psychological disorder
Patients undergoing chemotherapy
Alcohol dependency or evidence of substance abuse
Patients without any visual-perceptual problems
Patients without any communication barriers/language issue
Patients with no significant cognitive impairments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: SAME Therapy treatment protocols consist of 8 weeks of mental rehearsals of upper limb movements during 45-mints supervised sessions three times a week and structural independent sessions twice a week.</i_keyword>
      <i_keyword>Intervention group B: CIMT treatment protocol consists of 8 weeks of daily intensive training of the affected extremity for 2 hours per day, 5 days per week, and 8 weeks in association with restriction of the non-affected extremity for 10 hours a day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Upper limb strength. Timepoint: Total 8 week program and No followup. Primary outcome will be measured on 8th week. Method of measurement: Wolf motor function test, Action Research Arm Test.</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>Ripah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-01</approval_date>
        <contact_name>Ethics committee of Riphah College of Rehabilitation &amp; Allied health Sciences</contact_name>
        <contact_address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
