<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771872</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0154-004</org_study_id>
    <nct_id>NCT03771872</nct_id>
  </id_info>
  <brief_title>Virtual Prism Adaptation Therapy on Hemispatial Neglect</brief_title>
  <official_title>Effects of Virtual Prism Adaptation Therapy in Stroke Patients With Hemispatial Neglect</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bundang Rusk Rehabilitation Specialty Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of virtual prism adaptation therapy on&#xD;
      hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind,&#xD;
      sham-controlled, cross-over design. Total 10 patients will be allocated randomly to either&#xD;
      real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2&#xD;
      weeks. Two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided.&#xD;
      Behavioral outcomes will be measured before and after completing a total of 10 sessions&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment of subjects has been difficult.&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavioral Inattention Test (BIT) Score</measure>
    <time_frame>Change from Baseline at 5 days</time_frame>
    <description>Range: 0(best) to 227(worst)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BIT Conventional subtest score (BITC)</measure>
    <time_frame>Change from Baseline at 5 days</time_frame>
    <description>Range: 0(best) to 146(worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIT Behavioral subtest score (BITB)</measure>
    <time_frame>Change from Baseline at 5 days</time_frame>
    <description>Range: 0(best) to 81(worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comb and Razor Test</measure>
    <time_frame>Change from Baseline at 5 days</time_frame>
    <description>Range: 0% deviation (best) to 100% deviation (worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catherine Bergego Scale (CBS)</measure>
    <time_frame>Change from baseline at 5 days</time_frame>
    <description>Range: 0 (best) to 30 (worst)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Stroke</condition>
  <condition>Recovery of Function</condition>
  <condition>Rehabilitation</condition>
  <condition>Perceptual Disorders</condition>
  <condition>Virtual Reality Exposure Therapy</condition>
  <arm_group>
    <arm_group_label>Virtual Prism Adaptation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be provided with real virtual prism adaptation therapy. In the real therapy session, the hand trajectory will deviate to the right side in the virtual reality. The deviation angle will be adjusted according to the subject's adaptation. 20min-session will be provided twice a day for 5 days, then the total 10 sessions of therapy will be provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Prism Adaptation Therapy</intervention_name>
    <description>Hand trajectory will deviate to the right side in the virtual reality.</description>
    <arm_group_label>Virtual Prism Adaptation Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Therapy</intervention_name>
    <description>The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.</description>
    <arm_group_label>Sham Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3 months after stroke onset&#xD;
&#xD;
          -  2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line&#xD;
             bisection test, 2)Albert's test, 3)Drawing test.&#xD;
&#xD;
          -  Ability to recognize the target object, hand trajectory in the immersive virtual&#xD;
             reality&#xD;
&#xD;
          -  16 points or more in the Korean version of mini-mental state examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous stroke or traumatic brain injury history&#xD;
&#xD;
          -  Can not cooperate during the therapy, due to delirium or aphasia&#xD;
&#xD;
          -  Unstable medical conditions&#xD;
&#xD;
          -  Severe psychiatric symptoms that interfere with the therapy participation (e.g. severe&#xD;
             depression, agitation, psychotic symptoms)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Can not maintain sitting posture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bundang Rusk Rehabilitation Specialty Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13558</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Won-Seok Kim</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Perceptual Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771872
org study id: 2018-0154-004
nct id: NCT03771872
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effect of virtual prism adaptation therapy on
      hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind,
      sham-controlled, cross-over design. Total 10 patients will be allocated randomly to either
      real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2
      weeks. Two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided.
      Behavioral outcomes will be measured before and after completing a total of 10 sessions
      therapy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Behavioral Inattention Test (BIT) Score
time frame: Change from Baseline at 5 days
description: Range: 0(best) to 227(worst)
measure: BIT Conventional subtest score (BITC)
time frame: Change from Baseline at 5 days
description: Range: 0(best) to 146(worst)
measure: BIT Behavioral subtest score (BITB)
time frame: Change from Baseline at 5 days
description: Range: 0(best) to 81(worst)
measure: Comb and Razor Test
time frame: Change from Baseline at 5 days
description: Range: 0% deviation (best) to 100% deviation (worst)
measure: Catherine Bergego Scale (CBS)
time frame: Change from baseline at 5 days
description: Range: 0 (best) to 30 (worst)
arm group label: Virtual Prism Adaptation Therapy
arm group type: Experimental
description: This group will be provided with real virtual prism adaptation therapy. In the real therapy session, the hand trajectory will deviate to the right side in the virtual reality. The deviation angle will be adjusted according to the subject's adaptation. 20min-session will be provided twice a day for 5 days, then the total 10 sessions of therapy will be provided.
arm group label: Sham Therapy
arm group type: Sham Comparator
description: The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.
intervention type: Device
intervention name: Virtual Prism Adaptation Therapy
description: Hand trajectory will deviate to the right side in the virtual reality.
arm group label: Virtual Prism Adaptation Therapy
intervention type: Device
intervention name: Sham Therapy
description: The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.
arm group label: Sham Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Won-Seok Kim
investigator title: Assistant Professor
mesh term: Perceptual Disorders