<?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>IRCT20140304016830N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-23</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rehabilitation exercises on balance, eye movements and muscle activity level in patients with Parkinson's disease</public_title>
      <acronym></acronym>
      <scientific_title>A randomized controlled trial to compare the effect of competitive and noncompetitive exercises (playful ball exercises) with nonlinear pedagogy method on functional balance and mobility, eye movements and activity level of trunk muscles in patients with Parkinson's disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed by the person who is not involved in the study using sequentially numbered sealed envelopes, Blinding description: Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind on the groups allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson's disease.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Group receiving playful ball exercises in a competitive non-linear pedagogy method that receives 24 sessions of playful ball exercises in the form of volleyball in a competitive non-linear way (8 weeks, 3 sessions per week, 90 minutes per session) in addition to the conventional rehabilitation. Intervention 2: Second intervention group: Group receiving playful ball exercises in a noncompetitive non-linear pedagogy method that receives 24 sessions of playful ball exercises in the form of volleyball in a noncompetitive non-linear way (8 weeks, 3 sessions per week, 90 minutes per session) in addition to the conventional rehabilitation. Intervention 3: Control group: receives conventional rehabilitation.</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:
After the completion of this study, a manuscript regarding the documentation and the results of the study will be prepared and published.  If more details are needed, individuals can send their request by email to the person responsible for scientific accountability.

When:
8 months after publishing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Use of the documentation is permitted upon written permission.

Where to obtain:
Ghorban Taghizadeh
Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tel: 00982122227124
E-mail: taghizadeh.gh@iums.ac.ir

How to obtain:
Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghorban Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>taghizadeh.gh@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghorban Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>taghizadeh.gh@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having Parkinson's disease according to neurologist diagnosis (based on UK brain Bank criteria for the diagnosis of idiopathic PD)
Having the disease's progression level of 1 to 3 according to Hoehn and Yahr Scale
Having an acceptable level of cognitive function, i.e. score equal to or greater than 24 on the Mini Mental State Examinatio
Having at least a fifth grade education
Having the ability to walk at least 10 meters independently and without assistive device
Age between 35 to 70 years</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Co-morbid other neurological diseases, orthopedic disorders (such as low back pain and arthritis), diabetes or addiction according to the report of the patient, or patient's family or physician
Having pathologic dementia according to the neurologist diagnosis
Having Juvenile Parkinsonism</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>First intervention group: Group receiving playful ball exercises in a competitive non-linear pedagogy method that receives 24 sessions of playful ball exercises in the form of volleyball in a competitive non-linear way (8 weeks, 3 sessions per week, 90 minutes per session) in addition to the conventional rehabilitation.</i_keyword>
      <i_keyword>Second intervention group: Group receiving playful ball exercises in a noncompetitive non-linear pedagogy method that receives 24 sessions of playful ball exercises in the form of volleyball in a noncompetitive non-linear way (8 weeks, 3 sessions per week, 90 minutes per session) in addition to the conventional rehabilitation.</i_keyword>
      <i_keyword>Control group: receives conventional rehabilitation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional balance and mobility. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Fuctional reach test, Berg Balance Scale Questionnaire, Timed Up &amp; Go Test, Six Minute Walk Test, Gait speed.</prim_outcome>
      <prim_outcome>Eye movements. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Eye tracking system.</prim_outcome>
      <prim_outcome>Trunk muscle activity. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Electromyography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postural control. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Force plate (postural sway parameters).</sec_outcome>
      <sec_outcome>Ankle muscle activity. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Electromyography.</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>2017-12-08</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
