<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/NCT02258789</url>
  </required_header>
  <id_info>
    <org_study_id>UmeaU ClinNeuro HF Neglect</org_study_id>
    <secondary_id>UMU-2010-266-31M</secondary_id>
    <nct_id>NCT02258789</nct_id>
  </id_info>
  <brief_title>Assessment and Training Visio Spatial Neglect in a Virtual Reality Environment</brief_title>
  <acronym>RehAtt</acronym>
  <official_title>Assessment and Training Visio Spatial Neglect in a Virtual Reality Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umeå University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using&#xD;
      virtual technology, a new method (virtual reality, VR method) has been created which focuses&#xD;
      on stimulating attention networks: top down scanning training in a 3D game, combined with&#xD;
      intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training.&#xD;
&#xD;
      Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as&#xD;
      well as before and after training with the new VR method Method:- An intense visio spatial&#xD;
      scanning training, enhanced by directed visual, audio and tactile stimulation cues and&#xD;
      feedback, also including visio-motor activation was designed in a VR game. The in-house&#xD;
      developed software was based on the Tetris game. The VR method consists of an interactive 3D&#xD;
      environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15&#xD;
      patients with chronic (&gt;6 months) visio spatial neglect was included due to right-sided&#xD;
      ischemia. A VR neglect test battery including a Posner task were repeated three times during&#xD;
      a 5 weeks baseline before the training started (to establish the chronic state) and again&#xD;
      after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training&#xD;
      attention after stroke causing visio spatial neglect.&#xD;
&#xD;
      The method has been designed for home rehabilitation and is well suited for a tele-medicine&#xD;
      approach. It was built with standard components and is easy to manufacture at a low cost. The&#xD;
      idea is to give access to effective training, to make it available at the stroke unit with&#xD;
      the possibility for the patient to loan it it at discharge for home rehabilitation. The&#xD;
      concept of an all in one, easy-to-use device for testing, training and outcome evaluation&#xD;
      should be beneficial These preliminare results has been promising and indicates that the&#xD;
      RehAtt™ method could become an further developed into an effective and stimulating&#xD;
      intervention tool that would lower rehabilitation costs and reduce tiresome travelling to&#xD;
      hospitals for training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A VR environment was used training (RehAtt) of post-stroke patients with neglect. Patients&#xD;
      played the VR games three times a week for five weeks, totally 15 hours.&#xD;
&#xD;
      A neglect test battery five neglect tests was repeated three times during a five week&#xD;
      baseline to estabish a chronic state and reduce the test by test learning effect, then again&#xD;
      after the 5 weeks training period. The main outcome results were thereafter obtained by&#xD;
      comparing the 5 neglect tests: Star cancellation test, Baking Tray Task, Line Bisection,,&#xD;
      Extinction and Posner task - unified index by SPSS Repeated Measurement ANOVA from the 3&#xD;
      baseline visits to the results after intervention. The Catherine Bergego neglect scale was&#xD;
      used to assess activities in daily life before and after intervention as well as after six&#xD;
      months.&#xD;
&#xD;
      Patients were included if they had a neglect that had persisted for more than six months&#xD;
      after a right sided ishemic stroke.&#xD;
&#xD;
      Neglect was diagnosed if one or more of the four neglect subtests of the VR test battery was&#xD;
      below cut off (See below and Appendix for details).&#xD;
&#xD;
      The exclusion criteria were severe visual impairment, severe medical illness, severe&#xD;
      depression or cognitive dysfunction (MMSE ≤ 23 points). All patients received oral and&#xD;
      written information with an informed and signed consent. The Umeå university ethics review&#xD;
      board (IRB) approved the study (2010-266-31M).&#xD;
&#xD;
      The hardware consists of a standard PC, a video graphics card, a sound card, headphones and a&#xD;
      separate numeric keyboard to measure behavioural responses. In the VR test part, we used a&#xD;
      19&quot; CRT monitor and shutter glasses for stereoscopic vision. A 27&quot; monitor and 3D vision&#xD;
      glasses (Nvidia, Santa Clara, CA, USA) replaced them in the VR game part. A robotic pen&#xD;
      (Phantom omni haptic device, Sensable technologies, Wilmington, USA) was used as a pointer&#xD;
      using the right hand for assessment activities and the paretic left hand when playing the VR&#xD;
      game for intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neglect assessment clinical and behavioural</measure>
    <time_frame>within 1 week after intervention</time_frame>
    <description>Change in score in; Star cancellation test, Line Bisection, Baking tray task, Posner task, Extinction, Catherine Bergego scale (CBS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Catherine Bergego scale</measure>
    <time_frame>6 month follow up</time_frame>
    <description>Change in score in a scale for spatial attention in daily life activities, self report from patient and relative</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Hemispatial Neglect</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>intervention - control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 hours ( 3 times a week in 5 weeks) intense visio spatial scanning training Virtual Reality-method</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VR-method</intervention_name>
    <description>Neglect rehabilitation by intense scanning training and multi sensory stimuli using Virtual Reality</description>
    <arm_group_label>intervention - control</arm_group_label>
    <other_name>RehAtt</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neglect &gt; 6 months and after regular rehabilitation Stroke due to right sided ischemic&#xD;
             infarcts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe visual impairment, severe medical illness, severe depression or cognitive&#xD;
             dysfunction (MMSE ≤ 23 points).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helena Fordell, MD,</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pharmacology and Clinical Neuroscience Umea University, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Neuroscience</name>
      <address>
        <city>Umea</city>
        <zip>903 21</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>June 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke, rehabilitation, spatial neglect</keyword>
  <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/NCT02258789
org study id: UmeaU ClinNeuro HF Neglect
secondary id: UMU-2010-266-31M
nct id: NCT02258789
lead sponsor: 
has dmc: Yes
There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using
      virtual technology, a new method (virtual reality, VR method) has been created which focuses
      on stimulating attention networks: top down scanning training in a 3D game, combined with
      intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training.

      Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as
      well as before and after training with the new VR method Method:- An intense visio spatial
      scanning training, enhanced by directed visual, audio and tactile stimulation cues and
      feedback, also including visio-motor activation was designed in a VR game. The in-house
      developed software was based on the Tetris game. The VR method consists of an interactive 3D
      environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15
      patients with chronic (>6 months) visio spatial neglect was included due to right-sided
      ischemia. A VR neglect test battery including a Posner task were repeated three times during
      a 5 weeks baseline before the training started (to establish the chronic state) and again
      after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training
      attention after stroke causing visio spatial neglect.

      The method has been designed for home rehabilitation and is well suited for a tele-medicine
      approach. It was built with standard components and is easy to manufacture at a low cost. The
      idea is to give access to effective training, to make it available at the stroke unit with
      the possibility for the patient to loan it it at discharge for home rehabilitation. The
      concept of an all in one, easy-to-use device for testing, training and outcome evaluation
      should be beneficial These preliminare results has been promising and indicates that the
      RehAtt™ method could become an further developed into an effective and stimulating
      intervention tool that would lower rehabilitation costs and reduce tiresome travelling to
      hospitals for training.
A VR environment was used training (RehAtt) of post-stroke patients with neglect. Patients
      played the VR games three times a week for five weeks, totally 15 hours.

      A neglect test battery five neglect tests was repeated three times during a five week
      baseline to estabish a chronic state and reduce the test by test learning effect, then again
      after the 5 weeks training period. The main outcome results were thereafter obtained by
      comparing the 5 neglect tests: Star cancellation test, Baking Tray Task, Line Bisection,,
      Extinction and Posner task - unified index by SPSS Repeated Measurement ANOVA from the 3
      baseline visits to the results after intervention. The Catherine Bergego neglect scale was
      used to assess activities in daily life before and after intervention as well as after six
      months.

      Patients were included if they had a neglect that had persisted for more than six months
      after a right sided ishemic stroke.

      Neglect was diagnosed if one or more of the four neglect subtests of the VR test battery was
      below cut off (See below and Appendix for details).

      The exclusion criteria were severe visual impairment, severe medical illness, severe
      depression or cognitive dysfunction (MMSE ≤ 23 points). All patients received oral and
      written information with an informed and signed consent. The Umeå university ethics review
      board (IRB) approved the study (2010-266-31M).

      The hardware consists of a standard PC, a video graphics card, a sound card, headphones and a
      separate numeric keyboard to measure behavioural responses. In the VR test part, we used a
      19" CRT monitor and shutter glasses for stereoscopic vision. A 27" monitor and 3D vision
      glasses (Nvidia, Santa Clara, CA, USA) replaced them in the VR game part. A robotic pen
      (Phantom omni haptic device, Sensable technologies, Wilmington, USA) was used as a pointer
      using the right hand for assessment activities and the paretic left hand when playing the VR
      game for intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Neglect assessment clinical and behavioural
time frame: within 1 week after intervention
description: Change in score in; Star cancellation test, Line Bisection, Baking tray task, Posner task, Extinction, Catherine Bergego scale (CBS)
measure: Catherine Bergego scale
time frame: 6 month follow up
description: Change in score in a scale for spatial attention in daily life activities, self report from patient and relative
arm group label: intervention - control
arm group type: Experimental
description: 15 hours ( 3 times a week in 5 weeks) intense visio spatial scanning training Virtual Reality-method
intervention type: Other
intervention name: VR-method
description: Neglect rehabilitation by intense scanning training and multi sensory stimuli using Virtual Reality
arm group label: intervention - control
other name: RehAtt
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Helena Fordell, MD,
role: Principal Investigator
affiliation: Department of Pharmacology and Clinical Neuroscience Umea University, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Perceptual Disorders