<?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>IRCT20140416017301N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-20</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of  using of "Tele_Rehabilitation" and "Traditional methods"  on Upper limb Sensory-Motor Function of people with idiopathic Parkinson</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of upper extremity game play in the form of "Tele_Rehabilitation" on upper limb sensory-motor function of people with idiopathic Parkinson.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43329</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After finding patients as cases in hand or simple non probable which have  inclusion criteria people as absolute random( envelope sealed method) will be divided into three groups. All 3 groups participants will be received traditional treatment. In the other two groups, in addition to traditional treatment of the third group, they receive a treatment (Tele-rehab) in two different ways (with and without the therapist). 
In absolute random method (envelope and paper method), the name of group s will be written on a piece of paper and put in an envelope and the participants will be asked to choose one of the papers randomly then the patient will be placed in the chosen group, Blinding description: In this study, the participants are blind (in each 3 groups will be done traditional exercises) and the outcome assessor is also blind (Participants at a specific day without knowledge of each other's treatment referred to a center where the outcome assessor would be solely responsible for taking tests from patients without knowledge of the interventions and related participants).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group-  based on upper extremity game play activities  with "Tele-Rehabilitation" in clinic:                                                                             In this group, upper extremity exercise will be done with virtual reality technology in motor pattern needed for Parkinson diseases. Interventions will be done three days a week, for 24 sessions and everyone 1:15 minutes with presence of occupational therapist. Also occupational therapy traditional exercises include such as stretching, twisting, postural control and coordination will be done  in each session. Intervention 2: Intervention group- Intervention group based on upper extremity game play activities with "Tele-Rehabilitation" at home:  In this group, upper extremity exercise will be done with virtual reality technology in motor pattern needed for Parkinson diseases. Interventions will be done three days a week,  for 24 sessions and  everyone 1:15 minutes without presence of occupational therapist and also occupational therapy traditional exercises such as stretching, twisting, postural control and coordination will be done. Before starting these sessions patients will come to clinic for training and familiarizing with exercises and doing test before intervention. Intervention 3: Control group- Occupational therapy traditional exercise:                                     This exercises will be done for one and half hour and include such as  stretching, twisting, postural control and coordination.</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 This research is part of the next research.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram Azad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad Blv., Modar Sq., Shahnazari Ave., School of Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913187</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>azad.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Azad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad Ave, Modar Blvd, Nazari St, School of Rehabilition</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>154513187</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>azad.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with idiopathic Parkinson's disease on a scale of 1 to 4 on Hoehn &amp; Yahr Scale
Level of cognitive performance equal or above 21</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>having orthopedic problem</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group-  based on upper extremity game play activities  with "Tele-Rehabilitation" in clinic:                                                                             In this group, upper extremity exercise will be done with virtual reality technology in motor pattern needed for Parkinson diseases. Interventions will be done three days a week, for 24 sessions and everyone 1:15 minutes with presence of occupational therapist. Also occupational therapy traditional exercises include such as stretching, twisting, postural control and coordination will be done  in each session.</i_keyword>
      <i_keyword>Intervention group- Intervention group based on upper extremity game play activities with "Tele-Rehabilitation" at home:  In this group, upper extremity exercise will be done with virtual reality technology in motor pattern needed for Parkinson diseases. Interventions will be done three days a week,  for 24 sessions and  everyone 1:15 minutes without presence of occupational therapist and also occupational therapy traditional exercises such as stretching, twisting, postural control and coordination will be done. Before starting these sessions patients will come to clinic for training and familiarizing with exercises and doing test before intervention.</i_keyword>
      <i_keyword>Control group- Occupational therapy traditional exercise:                                     This exercises will be done for one and half hour and include such as  stretching, twisting, postural control and coordination.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sensory_ Motor Function in Upper Limb. Timepoint: Before intervention, after intervention , follow up after 2 month of intervention. Method of measurement: Wrist Position Sense Test, Shouder Position Sense Test, Hand Active Sensation Test, Box-Block Test, Purde-Peg Board Test, Coin Rotation Test, Nine hole Peg Test, Grip Dynamometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before intervention, after intervention, follow up 2 month after  intervention. Method of measurement: 	Parkinson Disease Questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-30</approval_date>
        <contact_name>Etics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Mirdamad Blvd., Modar Sq., Shah-Nazare St., School of Rehabilitation Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
