<?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>IRCT20120910010806N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-31</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Activity Based Interventions on  Performance  in People with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Visual Perception Interventions in Comparison with Conventional Occupational Therapy Interventions on Occupational Performance and Satisfaction in Performing Daily Activities in People with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36554</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method will be simple random sampling and by lottery method. the name of each patient is written on a piece of paper and placed inside the box.then pieces of paper extracted individually to complete the sample size for the intervention and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receives visual perception interventions with a three-dimensional printing pen for 2 sessions per week, 30 minutes per sessions for four weeks. In the first session  in addition to the explanation, therapist produces a three dimensional design in order to teach the method. In each session, the therapist presents a plan for producing a three-dimensional image for patient. In each session, four steps should be performed by the patient. In the first stage, Drawing lines on the plane. In this step, patients drew objects such as triangles or pentagons using stencils from the website (http://the3doodler.com/projects/). in the second stage, Drawing lines in the 3D space. In this step, patients recognized a 3D structure on paper and then drew lines in 3D space to recreate the same 3D structures dimensional space, in the third stage, Making structures by attaching 2D outputs. In this step, patients drew lines in separate planes using stencils and attached the planes to produce a complete 3D structure in the forth stage, Making structures by connecting 2D outputs with additional 3D drawing. In this step, patients drew lines using stencils and connected the plane lines to each other to produce a complete 3D structure with appropriate spatial configuration. Intervention 2: Control group: Receives conventional occupational therapy interventions for 8 sessions 2 times a week and 30 minutes per session. Interventions include:stretching and spasm control  exercises using with theraband and wedge, gross motor skills and balance using with steps, balance beam , parallel bars and tilt board and fine motor skills using with putty, peg board , eye hand coordination and eye foot coordination exercises with ball and peg board,exercises in PNF technic and activities daily of living.</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:
Article Published

When:
6 months after publication

To whom:
The researchers and Occupational Therapists

Conditions:
Other research, critics, check and clinical usage

Where to obtain:
First person in article

How to obtain:
Send request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasaman Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Occupatioanal Therapy department., School of rehabilitation sciencs.,Madadkaran Alley., Shah-Nazari Ave.,Madar Sq.,Mirdamad Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>yasamanrezaeiot@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Malahat Akbarfahi,i</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Occupational Therapy depatrment., School of rehabilitation., Madadkaran Ave., Shah-Nazari Ave., Madar Sq., Mirdamad Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913478</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>akbarfahimi.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age Between 18 and 50 years
Multiple Sclerosis Diagnosed by Neurologist
DTVP-A Score Below 90
MMSE Score Above 21
Normal Sightedness or Corrected with Assistive Devices
The Hand has the Ability to Grip and Use Three-dimensional Printing pen
At least 3 months have passed from relapse of the disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having Systemic Diseases, Diabates and any Disease other than MS that Affects the Visual System
Not Cooperating in Project</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receives visual perception interventions with a three-dimensional printing pen for 2 sessions per week, 30 minutes per sessions for four weeks. In the first session  in addition to the explanation, therapist produces a three dimensional design in order to teach the method. In each session, the therapist presents a plan for producing a three-dimensional image for patient. In each session, four steps should be performed by the patient. In the first stage, Drawing lines on the plane. In this step, patients drew objects such as triangles or pentagons using stencils from the website (http://the3doodler.com/projects/). in the second stage, Drawing lines in the 3D space. In this step, patients recognized a 3D structure on paper and then drew lines in 3D space to recreate the same 3D structures dimensional space, in the third stage, Making structures by attaching 2D outputs. In this step, patients drew lines in separate planes using stencils and attached the planes to produce a complete 3D structure in the forth stage, Making structures by connecting 2D outputs with additional 3D drawing. In this step, patients drew lines using stencils and connected the plane lines to each other to produce a complete 3D structure with appropriate spatial configuration</i_keyword>
      <i_keyword>Control group: Receives conventional occupational therapy interventions for 8 sessions 2 times a week and 30 minutes per session. Interventions include:stretching and spasm control  exercises using with theraband and wedge, gross motor skills and balance using with steps, balance beam , parallel bars and tilt board and fine motor skills using with putty, peg board , eye hand coordination and eye foot coordination exercises with ball and peg board,exercises in PNF technic and activities daily of living.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Occupational performance score in performing  daily activities. Timepoint: Pre and post treatment. Method of measurement: Canadian occupational performance measure (COPM).</prim_outcome>
      <prim_outcome>Satisfaction score in performing daily activities. Timepoint: Pre and post treatment. Method of measurement: Canadian occupational performance measure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depth perception. Timepoint: pre and post treatment. Method of measurement: depth perception peg board.</sec_outcome>
      <sec_outcome>Visual pathway. Timepoint: pre and post treatment. Method of measurement: visual evoked potential.</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>2018-12-09</approval_date>
        <contact_name>Iran University of Medical Sciences and health services</contact_name>
        <contact_address>Iran University of Medical Sciences., Shahid Hemmat highway., Tehran., Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
