<?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>IRCT20210615051585N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-24</date_registration>
      <primary_sponsor>Shifa Tameer e Millat University</primary_sponsor>
      <public_title>Effect of Virtual Reality combined with modified Constraint-Induced Movement Therapy based upper limb training on chronic stroke survivors</public_title>
      <acronym>Upper limb motor function recovery in stroke</acronym>
      <scientific_title>Effect of Virtual Reality combined with modified Constraint-Induced Movement Therapy based upper limb training on chronic stroke survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59139</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment for treatment using sealed envelope
26 Sheets of properly cut Aluminum paper double the size of the paper. 26 Sheets of Carbon paper cut into appropriate size according to the paper used.
A standard-sized square paper was taken in which group "(VR)" was marked. In this way, 13 papers were prepared marked with "(VR)" and 13 square-shaped papers marked with "(VR+mCIMT)". The sheet of paper on which either (VR) or (VR+mCIMT) was marked was folded to fit the envelope. A sheet of Carbon paper was placed on the top of the folded paper (marked either (VR) or (VR+mCIMT)) facing the envelope. Then the sheet of Aluminum foil was wrapped on the carbon paper (with folded paper inside). All the above prepared were placed in the envelope (which was completely opaque), the envelope was then sealed. In this way 13 envelops of "(VR)" and 13 envelops of "(VR+mCIMT)"were prepared. With a total number of 26 envelopes. These 26 envelopes were then thoroughly shuffled like a deck of cards.
The envelopes were then marked with numbers 1-26. Each participant picked the envelope in order from 1-26 and was given an intervention (VR or VR+mCIMT) accordingly, Blinding description: Participant don’t know about in what group they are. Only the researcher doing the study knows which treatment or intervention the participant is receiving.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Virtual reality Group:  Treatment for 20 min 3 sessions per week for 4 weeks along with the conventional therapy. The VR protocol included using VR headset and the games used were Rally ball and Reflex ridge. In the Rally ball game, balls approaching the player from multiple angles are hit from a chair. The Reflex Ridge game involves hitting, grasping obstacles while sitting in a chair. The patient played each game for 10-mins per session. Conventional therapy includes: passive stretching, repetitive task-specific activities, passive, active-assisted and active ROM exercises. Intervention 2: Virtual reality combined with m-CIMT Group: Treatment for 20 min 3 sessions per week for 4 weeks along with the conventional therapy. The unaffected hand of participant was restrained and then the same VR treatment (as above) given to the participants.</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 Due to Ethical Considerations</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Saima Gul</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 8441751</telephone>
        <email>saimaa.gul@gmail.com</email>
        <affiliation>Shifa Tameer e Millat University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Saima Gul</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 332 1964158</telephone>
        <email>saimaa.gul@gmail.com</email>
        <affiliation>Shifa Tameer e Millat University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ischemic stroke of MCA subjects suffering from stroke for at least 6 months
Both genders of age between 40 to 60 years
Having at least 10° of active extension of each MCP joint, IP joints of all the digits, and 10° wrist extension of the affected limb
Spasticity Grade 1 to 3 according to Modified Ashworth Scale</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with visual deficits
Patients not willing to use virtual reality or CIMT
Patients with cognitive disorders
Patients with upper limb contracture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Virtual reality Group:  Treatment for 20 min 3 sessions per week for 4 weeks along with the conventional therapy. The VR protocol included using VR headset and the games used were Rally ball and Reflex ridge. In the Rally ball game, balls approaching the player from multiple angles are hit from a chair. The Reflex Ridge game involves hitting, grasping obstacles while sitting in a chair. The patient played each game for 10-mins per session. Conventional therapy includes: passive stretching, repetitive task-specific activities, passive, active-assisted and active ROM exercises</i_keyword>
      <i_keyword>Virtual reality combined with m-CIMT Group: Treatment for 20 min 3 sessions per week for 4 weeks along with the conventional therapy. The unaffected hand of participant was restrained and then the same VR treatment (as above) given to the participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Upper limb motor function. Timepoint: Baseline, 2nd week and 4th week after intervention. Method of measurement: Wolf motor function test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spasticity. Timepoint: 4th week. Method of measurement: Modified Ash worth scale.</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>2021-04-01</approval_date>
        <contact_name>Institutional Review Board and Ethics Committee (IRB and EC) Shifa International Hospital and Shifa</contact_name>
        <contact_address>Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University Islamabad Islamabad Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
