<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/NCT02256007</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00031722</org_study_id>
    <nct_id>NCT02256007</nct_id>
  </id_info>
  <brief_title>Cognitive Motor Therapy Applications Using Videogame Platform</brief_title>
  <official_title>Cognitive Motor Therapy Applications Using Videogame Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Marble Rehab Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study designs and develops an evidence-based game approach that will enhance the&#xD;
      investigators understanding and usability of electronic tools to measure cognitive and&#xD;
      sensorimotor abilities in an inpatient rehabilitation stroke population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rehabilitation industry is the incipient stages of developing and using electronic based&#xD;
      assessment and intervention tools. With the growing understanding of cognitive recovery&#xD;
      following stroke, rehabilitation specialists are optimistic that appropriate rehabilitation&#xD;
      interventions may optimize and enhance functional outcomes. The use of technology based&#xD;
      assessments via video games may assist in a patient's cognitive recovery. Design and&#xD;
      development of an evidence-based game approach will enhance the investigators understanding&#xD;
      and usability of electronic tools to measure cognitive and sensorimotor abilities. There is&#xD;
      no intervention only an assessment for usability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not feasible in inpatient setting&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two treatment sessions during an inpatient rehabilitation stay. Part 1 is the screening (Montreal Cognitive Assessment and the Boston Diagnostic Aphasia Examination). Assessments will be given to make sure patient is eligible for the study. If eligible, will complete part 2-paper and pencil tasks and video game tests.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability Questionnaire</measure>
    <time_frame>Session in which participant completes standardized assessments before the patient's discharge from inpatient rehabilitation (within 2 weeks)</time_frame>
    <description>Participant will perform videogame assessments and standardized paper-pencil assessments and evaluate the utility of the touch screen tests compared to the traditional testing methods using the Usability Questionnaire. The focus will be on the Usability Questionnaire (not the video or paper assessments)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Standardized Assessments</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standardized Assessments (paper and pencil tests) to be given to each participant. The standardized assessments will be completed in paper and pencil format. These tests include:&#xD;
Line Bisection Test&#xD;
Patient Reported Outcomes&#xD;
Trial Making A and B&#xD;
Usability Questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Videogame Assessments</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Videogame assessments will be performed by each participant using videogames. The videogame assessments will be performed using videogames on a tabletop platform with touchscreen which includes:&#xD;
Line Crossing&#xD;
Patient Reported Outcomes&#xD;
Trial Making A &amp; B-Asteroid Adventure Game&#xD;
Usability Questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Paper and Pencil Assessments</intervention_name>
    <description>Videogame Assessments</description>
    <arm_group_label>Standardized Assessments</arm_group_label>
    <arm_group_label>Videogame Assessments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New onset stroke&#xD;
&#xD;
          -  Ability to follow one-step commands&#xD;
&#xD;
               -  All participants must be admitted to the inpatient rehabilitation unit at&#xD;
                  Cedars-Sinai Medical Center&#xD;
&#xD;
               -  Scores needed for Participation in Study on the Complex Ideational Material-Short&#xD;
                  Form from the Boston Diagnostic Aphasia Examination and the Montreal Cognitive&#xD;
                  Assessment:&#xD;
&#xD;
          -  Complex Ideational Material-Short Form from the Boston Diagnostic Aphasia&#xD;
             Examination-Participants must obtain a total score of at least 5/6 item pairs to&#xD;
             participate&#xD;
&#xD;
          -  Montreal Cognitive Assessment-Participants must obtain a total score of 16 or greater&#xD;
             and obtain a score of 6/6 on the orientation subtest&#xD;
&#xD;
          -  In order to participate, participants must meet both of the above criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not meet inclusion criteria as noted above.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela Roberts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Wertheimer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamela Roberts</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>King M, Hale L, Pekkari A, Persson M, Gregorsson M, Nilsson M. An affordable, computerised, table-based exercise system for stroke survivors. Disabil Rehabil Assist Technol. 2010 Jul;5(4):288-93. doi: 10.3109/17483101003718161.</citation>
    <PMID>20302419</PMID>
  </reference>
  <reference>
    <citation>Lewis GN, Rosie JA. Virtual reality games for movement rehabilitation in neurological conditions: how do we meet the needs and expectations of the users? Disabil Rehabil. 2012;34(22):1880-6. doi: 10.3109/09638288.2012.670036. Epub 2012 Apr 5.</citation>
    <PMID>22480353</PMID>
  </reference>
  <reference>
    <citation>Lewis GN, Woods C, Rosie JA, McPherson KM. Virtual reality games for rehabilitation of people with stroke: perspectives from the users. Disabil Rehabil Assist Technol. 2011;6(5):453-63. doi: 10.3109/17483107.2011.574310. Epub 2011 Apr 17.</citation>
    <PMID>21495917</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 28, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Pamela Roberts</investigator_full_name>
    <investigator_title>Program Director</investigator_title>
  </responsible_party>
  <keyword>Videogames; stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No subjects completed study</ipd_description>
  </patient_data>
  <!-- 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/NCT02256007
org study id: Pro00031722
nct id: NCT02256007
lead sponsor: 
collaborator: 
has dmc: No
This study designs and develops an evidence-based game approach that will enhance the
      investigators understanding and usability of electronic tools to measure cognitive and
      sensorimotor abilities in an inpatient rehabilitation stroke population.
The rehabilitation industry is the incipient stages of developing and using electronic based
      assessment and intervention tools. With the growing understanding of cognitive recovery
      following stroke, rehabilitation specialists are optimistic that appropriate rehabilitation
      interventions may optimize and enhance functional outcomes. The use of technology based
      assessments via video games may assist in a patient's cognitive recovery. Design and
      development of an evidence-based game approach will enhance the investigators understanding
      and usability of electronic tools to measure cognitive and sensorimotor abilities. There is
      no intervention only an assessment for usability.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two treatment sessions during an inpatient rehabilitation stay. Part 1 is the screening (Montreal Cognitive Assessment and the Boston Diagnostic Aphasia Examination). Assessments will be given to make sure patient is eligible for the study. If eligible, will complete part 2-paper and pencil tasks and video game tests.
primary purpose: Other
masking: None (Open Label)
measure: Usability Questionnaire
time frame: Session in which participant completes standardized assessments before the patient's discharge from inpatient rehabilitation (within 2 weeks)
description: Participant will perform videogame assessments and standardized paper-pencil assessments and evaluate the utility of the touch screen tests compared to the traditional testing methods using the Usability Questionnaire. The focus will be on the Usability Questionnaire (not the video or paper assessments)
arm group label: Standardized Assessments
arm group type: Active Comparator
description: Standardized Assessments (paper and pencil tests) to be given to each participant. The standardized assessments will be completed in paper and pencil format. These tests include:
Line Bisection Test
Patient Reported Outcomes
Trial Making A and B
Usability Questionnaire
arm group label: Videogame Assessments
arm group type: Experimental
description: Videogame assessments will be performed by each participant using videogames. The videogame assessments will be performed using videogames on a tabletop platform with touchscreen which includes:
Line Crossing
Patient Reported Outcomes
Trial Making A & B-Asteroid Adventure Game
Usability Questionnaire
intervention type: Other
intervention name: Paper and Pencil Assessments
description: Videogame Assessments
arm group label: Standardized Assessments
arm group label: Videogame Assessments
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pamela Roberts, PhD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Jeffrey Wertheimer, PhD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
citation: King M, Hale L, Pekkari A, Persson M, Gregorsson M, Nilsson M. An affordable, computerised, table-based exercise system for stroke survivors. Disabil Rehabil Assist Technol. 2010 Jul;5(4):288-93. doi: 10.3109/17483101003718161.
PMID: 20302419
citation: Lewis GN, Rosie JA. Virtual reality games for movement rehabilitation in neurological conditions: how do we meet the needs and expectations of the users? Disabil Rehabil. 2012;34(22):1880-6. doi: 10.3109/09638288.2012.670036. Epub 2012 Apr 5.
PMID: 22480353
citation: Lewis GN, Woods C, Rosie JA, McPherson KM. Virtual reality games for rehabilitation of people with stroke: perspectives from the users. Disabil Rehabil Assist Technol. 2011;6(5):453-63. doi: 10.3109/17483107.2011.574310. Epub 2011 Apr 17.
PMID: 21495917
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Pamela Roberts
investigator title: Program Director
mesh term: Stroke
sharing ipd: No
ipd description: No subjects completed study