<?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>IRCT20180815040804N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-26</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>"The action observation therapy and mirror therapy on treatment of upper limb stroke patients"</public_title>
      <acronym></acronym>
      <scientific_title>"Comparison of the effect of action observation therapy and mirror therapy on upper extremity functions in patients with stroke"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34000</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomized, Blinding description: Participants do not inform about interventions present to each other.</study_design>
      <phase>3</phase>
      <hc_freetext>stroke patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Patients in the mirror group will receive mirror therapy for 30 minutes per session, 3 sessions per week, for 4 weeks in addition to the intervention of the control group. In this intervention, the patient sit on a chair in front of a table and a mirror dimensions 50*62 cm will  be placed on the desk, parallel with the midline of the body and between the paretic and nonparetic upper extremity. Patients will be asked to gaze at the nonparetic upper extremity reflected in the mirror. The activities of the mirror therapy group includes: Range of motion exercises such as elbow flexion.extension, forearm supination.pronation , wrist and fingers flexion.extension, fisting and releasing, reaching and upper extremity functional tasks. The exercises will be presented  proportionally to each person's  ability of the upper extremity. The patients will be asked to repeat each movement 30 times per set for three sets, with 1-minute break between sets. During intervention participants will be encouraged to actively move their hands and simultaneously move their nonparetic side reflected in the mirror. If patients unable to move their paretic upper extremity the therapist will help them. Intervention 2: Intervention group 2: Patients in the action observation therapy group will receive action observation therapy for 30 minutes per session, 3 sessions per week, for 4 weeks in addition to the intervention of the control group. In this intervention, the patient sit on a chair in front of the laptop. In the action observation group, patients will see the activities through the video and then perform the observed movements with both upper extremities simultaneously. Each functional task is divided into three motor actions. After observing a motor action for 2 minutes, patients will be asked to perform the observed motor action for 3 minutes. This step will be repeated three times, with 1-minute break between times. Then the patients will observe the functional task as a whole motor action for 2 minutes and then perform whole task for 3 minutes. This step will also be repeated three times. The activities of the action observation therapy group will include the range of motion exercises such as elbow flexion.extension, forearm supination.pronation, wrist and fingers flexion.extension, fisting and releasing, reaching and upper extremity functional tasks. The exercises will be presented proportionally to each person's ability of the upper extremity. If patients unable to move their paretic upper extremity the therapist will help them. Intervention 3: Control group: Conventional intervention includes upper extremity range of motion exercises, Bobath and PNF Techniques and strength training. Conventional intervention will apply for 45 minutes per session, 3 sessions per week, for 4 weeks. The control group will receive upper extremity exercises for 45 minutes without watching video or performing activities in front of the mirror.</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:
Statistical outcomes include MD, SD

When:
"From article acceptation"

To whom:
"Practitioners and students"

Conditions:
"Use of data with permission"

Where to obtain:
Dr Mino Kalantari, Assistant professor of SBMU School of Rehabilitation Sciences
Address: SBMU School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital, Tehran, Iran
Email: mn_kalantari@yahoo.com
Zip Code: 1616913111
Tel: 00982177548496

How to obtain:
Email to: mn_kalantari@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elnaz Fadaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBMU School of Rehabilitation Sciences,  Damavand St, Across from Bu Ali Hospital,  Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>fadaei_elnaz@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Kalantari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBMU School of Rehabilitation Sciences,  Damavand St, Across from Bu Ali Hospital,  Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>mn_kalantari@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A diagnosis of hemiplegia due to stroke
6 months to 5 years of stroke
Stage3, 4, 5 and 6 Brunnstrom in proximal and distal of upper extremities
Obtaining at least 18 score from the Mini-Mental Status Examination
Voluntary consent to participate in the study
Age range 30-70 years</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>VI</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the nervous system</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 1: Patients in the mirror group will receive mirror therapy for 30 minutes per session, 3 sessions per week, for 4 weeks in addition to the intervention of the control group. In this intervention, the patient sit on a chair in front of a table and a mirror dimensions 50*62 cm will  be placed on the desk, parallel with the midline of the body and between the paretic and nonparetic upper extremity. Patients will be asked to gaze at the nonparetic upper extremity reflected in the mirror. The activities of the mirror therapy group includes: Range of motion exercises such as elbow flexion.extension, forearm supination.pronation , wrist and fingers flexion.extension, fisting and releasing, reaching and upper extremity functional tasks. The exercises will be presented  proportionally to each person's  ability of the upper extremity. The patients will be asked to repeat each movement 30 times per set for three sets, with 1-minute break between sets. During intervention participants will be encouraged to actively move their hands and simultaneously move their nonparetic side reflected in the mirror. If patients unable to move their paretic upper extremity the therapist will help them.</i_keyword>
      <i_keyword>Intervention group 2: Patients in the action observation therapy group will receive action observation therapy for 30 minutes per session, 3 sessions per week, for 4 weeks in addition to the intervention of the control group. In this intervention, the patient sit on a chair in front of the laptop. In the action observation group, patients will see the activities through the video and then perform the observed movements with both upper extremities simultaneously. Each functional task is divided into three motor actions. After observing a motor action for 2 minutes, patients will be asked to perform the observed motor action for 3 minutes. This step will be repeated three times, with 1-minute break between times. Then the patients will observe the functional task as a whole motor action for 2 minutes and then perform whole task for 3 minutes. This step will also be repeated three times. The activities of the action observation therapy group will include the range of motion exercises such as elbow flexion.extension, forearm supination.pronation, wrist and fingers flexion.extension, fisting and releasing, reaching and upper extremity functional tasks. The exercises will be presented proportionally to each person's ability of the upper extremity. If patients unable to move their paretic upper extremity the therapist will help them.</i_keyword>
      <i_keyword>Control group: Conventional intervention includes upper extremity range of motion exercises, Bobath and PNF Techniques and strength training. Conventional intervention will apply for 45 minutes per session, 3 sessions per week, for 4 weeks. The control group will receive upper extremity exercises for 45 minutes without watching video or performing activities in front of the mirror.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Upper extremity function based on Box and Block Test and Fugl-Meyer Assessment". Timepoint: "Measurement by Box and Block Test: Before intervention and end of sessions 3, 6, 9 and 12. Measurement by Fugl-Meyer Assessment: Before and after intervention". Method of measurement: "Box and Block Test, Fugl-Meyer Assessment".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>"functional independence score". Timepoint: "Before the intervention, after the intervention". Method of measurement: "Functional Independence Measure".</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-21</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
