<?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>IRCT20241016063384N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-04</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>virtual reality in upper extremity of stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of specific exercise training using virtual reality on upper extremity function of stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79599</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization of the dice roll type
For each participant, we use a dice or similar random device.
For example, if the dice is six-sided:
Number 1 to 3: The participant is assigned to group A (eg, the experimental group).
Number 4 to 6: The participant is assigned to group B (ie, the control group).
Conclusion: With this method, each participant has an equal chance to be placed in each group, which helps to reduce the influence of biases and increase the accuracy of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cerebrovascular disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Initially, the treatment involves electrotherapy and routine exercises such as hand bicycle, push-ups, and pulley system exercises. Afterward, the patient performs specialized exercises, including tasks such as reaching for a target with the hand, moving the upper torso and head towards a target, grabbing, moving, and tracking an object, and finally hand supination and pronation exercises. All of these exercises are shown to the patient through a virtual reality system via a monitor, which then provides feedback to the patient. Intervention 2: Control group:Initially, electrotherapy and routine exercises such as hand cycling, push-ups, and pulley system exercises are performed. Then, the patient performs specific exercises, which include: reaching the hand towards a target, reaching the head and upper trunk towards a target, reaching the hand to a target, grasping, moving, and tracking it, and finally, supination and pronation exercises of the hand. All these exercises are demonstrated by the therapist, who then provides feedback to the patient.".</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
--

When:
--

To whom:
--

Conditions:
--

Where to obtain:
--

How to obtain:
--

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Kamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.56,Nastaran 13 building, Shahid Beheshti Town, Babaei Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۶۵۱۱۳۹۵۴۷</zip>
        <telephone>+98 21 7710 4133</telephone>
        <email>monakamali9840@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mona Kamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No56,Nastaran 13 building, Shahid Beheshti Town, Babaei Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1651139547</zip>
        <telephone>+98 21 7710 4133</telephone>
        <email>monakamali9840@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with ischemic or hemorrhagic stroke confirmed by a neurologist.
Stroke patients aged 40 years or older who are willing and able to give informed consent to participate in the study.
Only patients experiencing their first stroke or recurrent stroke without any lasting motor impairment from a previous stroke.
Individuals who have had a stroke within the past 36 months.
Individuals with relative and minimal active movement in the proximal and distal parts of the affected upper limb
Individuals should be free of apraxia.
No complete paralysis of the upper limb.
No fractures or dislocations of the affected upper limb.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The participant's unwillingness to continue the study for any reason
Lack of medical stability
Musculoskeletal pain that prevents the treatment
Patients with cognitive impairment (score of 20 or lower on the mental status assessment test) should be excluded.
excessive spasticity, MAS score no higher than 2).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebellar stroke syndrome</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:Initially, the treatment involves electrotherapy and routine exercises such as hand bicycle, push-ups, and pulley system exercises. Afterward, the patient performs specialized exercises, including tasks such as reaching for a target with the hand, moving the upper torso and head towards a target, grabbing, moving, and tracking an object, and finally hand supination and pronation exercises. All of these exercises are shown to the patient through a virtual reality system via a monitor, which then provides feedback to the patient.</i_keyword>
      <i_keyword>Control group:Initially, electrotherapy and routine exercises such as hand cycling, push-ups, and pulley system exercises are performed. Then, the patient performs specific exercises, which include: reaching the hand towards a target, reaching the head and upper trunk towards a target, reaching the hand to a target, grasping, moving, and tracking it, and finally, supination and pronation exercises of the hand. All these exercises are demonstrated by the therapist, who then provides feedback to the patient."</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ROM of upper extremity. Timepoint: before and after. Method of measurement: goniametry.</prim_outcome>
      <prim_outcome>Activity Of Daily Living. Timepoint: before and after. Method of measurement: modified bartel scale.</prim_outcome>
      <prim_outcome>Upper extremity function. Timepoint: before and after. Method of measurement: wolf motor function 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-23</approval_date>
        <contact_name>The Ethics Committee of the University of social welfare and Rehabilitation Sciences</contact_name>
        <contact_address>No.56,Nastaran 13 building,Shahid Beheshti Town,Babaei Hwy Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
