<?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>IRCT20211022052835N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-10</date_registration>
      <primary_sponsor>Shifa Tameer-e-Millat University</primary_sponsor>
      <public_title>Comparison of modified Constraint Induced Movement Therapy (mCIMT) and mirror therapy (MT) in addition to neuromuscular electrical stimulation (NMES) on upper extremity function of chronic stroke patients</public_title>
      <acronym>Nill</acronym>
      <scientific_title>Comparison of modified Constraint Induced Movement Therapy (mCIMT) and mirror therapy (MT) in addition to neuromuscular electrical stimulation (NMES) on upper extremity function of chronic stroke patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59579</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 patient for their participation in the study, the therapist opens the envelop and give the respective treatments to the patients . The study is single blinded as participants is not aware of the intervention group they are placed in, Blinding description: Participants are single blinded as they don't know which treatment plan or intervention is given to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Only diagnosed hemiplegic stroke patients past 6 months who do have minimal function of hand thumb and fingers..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A is given mCIMT treatment. This group received modified constraint-Induced therapy for 4 sessions per week for 4 weeks, applied for 30 minutes. Patient wore a mitt on his/her unaffected arm.Patient performed repetitive task training with his/her affected arm such as picking up the ball from the basket and placing it back, picking up the coins, counting numbers on finger, slowly opening and closing of fist, turning of palm. Patient was also advised to keep performing activities with his/her paretic arm while wearing the mitt on less affected arm at home as well. Intervention 2: Intervention group B. This group received mirror therapy (MT) in addition to NMES.Mirror therapy 4 sessions per week for 4 weeks applied for 30 minutes. Activity based therapy was done like opening and closing of fist, touching thumb with the tip of each finger, wipe the table with washcloth in circular motion, back and forth, up and down, picking up the coins. Along with this, NMES was applied on extensor muscles of wrist and hand for 20 minutes for which frequency was set between 20-50 Hz, with 30-70 mA intensity lasted for 8 seconds and then stopped for 8 seconds.</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>Aqsa Siddique</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no. 274, Street no. 11 Block-I Gulberg Residencia</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 340 3789675</telephone>
        <email>saqsa567@gmail.com</email>
        <affiliation>Shifa tameer-e- millat university islamabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 40 to 65 years
Both gender
Hemiplegic stroke patients past 6 months
Minimal function of hand includes 10° wrist extension, 10° thumb extension, 10° finger extension
Absence of severe attentive deficit
Will able to understand and follow simple verbal instructions
Have no severe cognitive disorder that interferes with the study.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Upper limb fracture
Peripheral nerve injury
Apraxia
Visual field defect
A serious cardiac disease ( arrhythmias and pacemakers)
Skin or peripheral circulation disorder
Those who participate in other studies or rehabilitation program.
Chronic synergies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G81.90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemiplegia, unspecified 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 A is given mCIMT treatment. This group received modified constraint-Induced therapy for 4 sessions per week for 4 weeks, applied for 30 minutes. Patient wore a mitt on his/her unaffected arm.Patient performed repetitive task training with his/her affected arm such as picking up the ball from the basket and placing it back, picking up the coins, counting numbers on finger, slowly opening and closing of fist, turning of palm. Patient was also advised to keep performing activities with his/her paretic arm while wearing the mitt on less affected arm at home as well.</i_keyword>
      <i_keyword>Intervention group B. This group received mirror therapy (MT) in addition to NMES.Mirror therapy 4 sessions per week for 4 weeks applied for 30 minutes. Activity based therapy was done like opening and closing of fist, touching thumb with the tip of each finger, wipe the table with washcloth in circular motion, back and forth, up and down, picking up the coins. Along with this, NMES was applied on extensor muscles of wrist and hand for 20 minutes for which frequency was set between 20-50 Hz, with 30-70 mA intensity lasted for 8 seconds and then stopped for 8 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To compare the effect of modified constraint induced movement therapy with mirror therapy in addition to neuromuscular electrical stimulation on upper extremity of chronic stroke patients. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Modified barthel index , Wolf motor scale and Upper limb Motor assessment scale.</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>Shifa Tameer-e-Millat University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-16</approval_date>
        <contact_name>Institutional review board and ethical committee shifa tameer-e-millat and shifa international hospi</contact_name>
        <contact_address>Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad Islamabad  Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
