<?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>IRCT20211017052790N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-08</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of virtual reality on gait of post stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of virtual reality training compared with convectional physiotherapy on kinematics and spasticity of lower limb during gate of post stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59395</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: In each envelopes, we write number 1 or 2. If patient pick envelope with number 1, patient will allocate in experience group and if patient pick envelope with number 2, patient will allocate in control group, Blinding description: The initial and final evaluation is performed by a therapist who does not know the allocation of patients.
The outcome analyzer has no knowledge of patient grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Ischemic Cerebral Vascular accident.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group receive virtual reality treatment with Xbox 360 console. Every sessions of treatment have 40 minute virtual reality, using 2 games, 3 days per week for 3 weeks. Patients play each game for 20 minutes.  The first game used is soccer. The game is that the patient is in the form of a football player who uses the movement of the lower limb in front of the Kinect camera to pass the ball to his teammates and finally enter the goal with a shot.The second game is track and field, which is a collection of athletics games. In this game, the patient must stand in front of the camera and raise his lower limbs in a running position with the sound of a whistle and the start of the race, so that the knees rise. The purpose of this game is to win the race. The faster this limb movement, the faster the avatar runs. Intervention 2: In the control group, patients receive ND-Bobath (Neuro developmental Therapy -Bobath) for 40 minutes per day, 3 sessions per week (every other day) and 3 weeks. The emphasis of the exercises is on the rehabilitation of the lower limbs and walking of these patients.parallel walking, balance exercises, weightlifting on the affected lower limb, isolated dorsi flexion and knee flexion control, pelvic control, bridging exercises, ankle mobilization and Gastrocnemius muscle stretching are some of the exercises for these patients. It is performed in each session in the clinic environment and under the supervision of the therapist. During the treatment of patients in the control group, the therapist accelerates the treatment process by providing appropriate feedback to correct incorrect patterns.</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:
The file of the participants will be presented in general and in detail in the form of a dissertation. Also, the study protocol, statistical analysis map along with statistical methods used in the study and clinical study report will be presented in the form of a dissertation. The informed consent form of the patients will be made available to the public as an attachment along with the dissertation.

When:
Start of the access period 3 months after the publication of the results and the defense of the dissertation

To whom:
All researchers working in academic and scientific institutions
Community Verified icon

Conditions:
In order to use the study to treat patients as well as the scientific development of the study, they will be allowed to access the study.

Where to obtain:
ِDr. Minoo Khalkhali (responsible for the study)
Danial Sajjadi (Executor of plan) E-mail: danial199728@gmail.com
School of rehabilitation of Shahid Beheshti medical university

How to obtain:
By providing the necessary documents for the reason for using or how to use the study, they can have full access to the study through the study manager and the project manager.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Minoo Khalkhali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of rehabilitation of shahid beheshti medical university, Damavand St., Imam Hossein Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>minoo_kh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Khalkhali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of rehabilitation of Shahid Beheshti medical university, Damavand St., Imam Hossein Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>minoo_kh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-75 years with ischemic stroke
Stroke occurred at least 3 month ago
Patient just had 1 stroke
Patient can independently walk at least 10 meters
Patient didn't experience therapy with VR
Complications of the limbs should be hemiplegia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient have acute cardio respiratory disorders
Patient have severe orthopedic or bio mechanical disorders in lower limb
Patient have cognitive or vision disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemiplegia and hemiparesis</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 receive virtual reality treatment with Xbox 360 console. Every sessions of treatment have 40 minute virtual reality, using 2 games, 3 days per week for 3 weeks. Patients play each game for 20 minutes.  The first game used is soccer. The game is that the patient is in the form of a football player who uses the movement of the lower limb in front of the Kinect camera to pass the ball to his teammates and finally enter the goal with a shot.The second game is track and field, which is a collection of athletics games. In this game, the patient must stand in front of the camera and raise his lower limbs in a running position with the sound of a whistle and the start of the race, so that the knees rise. The purpose of this game is to win the race. The faster this limb movement, the faster the avatar runs.</i_keyword>
      <i_keyword>In the control group, patients receive ND-Bobath (Neuro developmental Therapy -Bobath) for 40 minutes per day, 3 sessions per week (every other day) and 3 weeks. The emphasis of the exercises is on the rehabilitation of the lower limbs and walking of these patients.parallel walking, balance exercises, weightlifting on the affected lower limb, isolated dorsi flexion and knee flexion control, pelvic control, bridging exercises, ankle mobilization and Gastrocnemius muscle stretching are some of the exercises for these patients. It is performed in each session in the clinic environment and under the supervision of the therapist. During the treatment of patients in the control group, the therapist accelerates the treatment process by providing appropriate feedback to correct incorrect patterns.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hip flexion and extension, abduction and adduction Range of motion during gait. Timepoint: Before and after intervention. Method of measurement: Motion analysis system, cameras and markers.</prim_outcome>
      <prim_outcome>Knee flexion and extension range of motion during gait. Timepoint: Before and after intervention. Method of measurement: motion analysis system, cameras and markers.</prim_outcome>
      <prim_outcome>Ankle plantar flexion and dorsi flexion range of motion during gait. Timepoint: Before and after intervention. Method of measurement: Motion analysis system, cameras and markers.</prim_outcome>
      <prim_outcome>Spasticity of Adductors of hip, Quadriceps and Gastrocnemius muscles. Timepoint: Before and after intervention. Method of measurement: modify modify Ashworth scale.</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>Vice-Chancellor's Office for Research of Shahid Beheshti medical university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-11</approval_date>
        <contact_name>Ethics committe of shahid beheshti medical university</contact_name>
        <contact_address>No. 26, West zayande rood alley, North shirazi St. Molla sadra Ave., Vanak Sq. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
