<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/NCT02220816</url>
  </required_header>
  <id_info>
    <org_study_id>NISA-COG-2014/1</org_study_id>
    <nct_id>NCT02220816</nct_id>
  </id_info>
  <brief_title>Efficacy of an Attentional Process Training Using Competitive Versus Non Competitive Strategies</brief_title>
  <official_title>Efficacy of an Attentional Process Training Using Competitive Versus Non Competitive Strategies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospitales Nisa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitat Politècnica de València</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Seville</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospitales Nisa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Within a prospective, randomised, controlled study 60, selected patients with chronic (&gt; 6&#xD;
      months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of&#xD;
      competitive versus non-competitive attentional training. Competitive training will include&#xD;
      fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations&#xD;
      and fifteen 1-hour sessions of competitive attentional games designed for this purpose using&#xD;
      a new virtual reality system (conventional liquid-crystal-display screen with an infrared LED&#xD;
      array to facilitate multi-touch experience embedded in a conventional table). Progress will&#xD;
      be evaluated by pre and post measurement of attentional neuropsychological tests, subjective&#xD;
      reports of global attention, usability and motivational scales. Our hypothesis is that&#xD;
      competitive training is more effective in improving attention than conventional training in&#xD;
      the chronic phase after acquired brain injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants: Sixty 18-75 years-old patients with acquired brain injury, will be randomly&#xD;
      assigned to 30 sessions of competitive versus non-competitive cognitive attentional training&#xD;
      (see inclusion-exclusion criteria). Material and Methods: Randomized clinical trial comparing&#xD;
      two different attentional training strategies. Attentional measures, usability data and&#xD;
      caregiver/family perception of change, will be compared after completing both conditions.&#xD;
      Competitive training will include a new computer based training program that involve using&#xD;
      attentional skills under different competitive scenarios. Attentional exercises were designed&#xD;
      according to the instructions of two experts neuropsychologists and included game-based&#xD;
      situations simulating different olympic disciplines.Neuropsychological protocol: An&#xD;
      assessment before the beginning of the intervention and pos-treatment will be done by a&#xD;
      trained blinded neuropsychologist using measures of selective, sustained, divided and&#xD;
      alternating attention (see primary outcome measures). Usability and Motivation: It is&#xD;
      well-known that game-based cognitive exercises can increase motivation to treatment which in&#xD;
      turn can increase learning strategies and improve outcomes after rehabilitation processes.&#xD;
      Competitive tasks can also improve the effort and interest of the players and the intensity&#xD;
      of the task through increasing motivation to win, get a reward and beat the others. Since&#xD;
      motivation was an important element of our research, we assessed this capacity at the end of&#xD;
      the treatment with the Intrinsic Motivation Scale. Also, the revised Competitiveness Index&#xD;
      was used to measure the subject's preference for competitive situations. Finally, usability&#xD;
      was considered a secondary outcome of our study since most of the games employed here were&#xD;
      designed to be played in a new virtual reality system which was build to facilitate&#xD;
      competitive strategies among 2-4 players (see secondary outcomes). Sample Size Calculation:&#xD;
      There was any previous study that used the design proposed in this investigation. Considering&#xD;
      a reduction bigger of 20% on the Hit-Reaction Time of the CPT-II scores in the active group&#xD;
      intervention, sample size in both groups of 27 participants and standard-deviation in the&#xD;
      magnitude of half of the medium score in each group (moderate variability), the study will be&#xD;
      able to detect a moderate effect size (ES = 0,4). Calculating a sample loss of 10% each&#xD;
      group, we define a sample size per group of 30 individuals. Statistical methods Statistical&#xD;
      analyses will be performed with Statistical Package for the Social Sciences (SPSS) 12.0. The&#xD;
      univariate analyses will be performed with the t student test / Mann-Whitney to continuous&#xD;
      variables or Chi-Square test (X²) / Fischer test to categorical variables. The effective of&#xD;
      the intervention over time will be assess through analyses of mixed models (repeated measures&#xD;
      ANOVA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in attentional psychometric measures</measure>
    <time_frame>Baseline versus end of treatment (an expected average of 8 weeks)</time_frame>
    <description>Neuropsychological battery: Conner's Continuous Performance Test (CPT-II), Color-Trail Test, d2, Stroop test, Wechsler Adult Intelligence Scale-IV digit-span, Corsi block-tapping test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usability measures</measure>
    <time_frame>Baseline versus end of treatment (an expected average of 8 weeks)</time_frame>
    <description>System Usability Scale, Intrinsic Motivation Inventory</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Family-centered outcomes</measure>
    <time_frame>Baseline versus end of treatment (an expected average of 8 weeks)</time_frame>
    <description>Moos Attention Rating Scale, Subjective perception of improvement</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Stroke</condition>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>Competitive Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will receive only competitive activities designed to restore attention abilities. These include pencil-and-paper tasks completed under competitive circumstances and competitive virtual games specifically designed to treat different aspects of attention (divided, selective, sustained, etc).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Competitive Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will receive conventional attentional training. Pencil and paper tasks focused on different aspects of attention (divided, selective, sustained, etc.) will be completed by all participant under individual or group-therapy sessions. No competitive training will be allowed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Competitive training</intervention_name>
    <description>30 sessions of competitive cognitive training; 3 - 5 sessions/week; duration 45 min</description>
    <arm_group_label>Competitive Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-Competitive Training</intervention_name>
    <description>30 sessions of non-competitive cognitive training; 3 - 5 sessions/week; duration 45 min</description>
    <arm_group_label>Non-Competitive Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acquired brain injury patients (stroke and traumatic brain injury)&#xD;
&#xD;
          -  Chronicity &gt; 6 months&#xD;
&#xD;
          -  More than 3 months under cognitive rehabilitation&#xD;
&#xD;
          -  Mississippi Aphasia Screening Test (comprehension subtest &gt; 45)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment defined as &lt; 23 on Mini Mental Status Examination&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Visual or auditive disorders limiting the ability to comply with treatment regimen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto Llorens, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat Politècnica de València</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospitales NISA</name>
      <address>
        <city>Valencia</city>
        <zip>46011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 18, 2015</last_update_submitted>
  <last_update_submitted_qc>August 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attention</keyword>
  <keyword>Competitive</keyword>
  <keyword>Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</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/NCT02220816
org study id: NISA-COG-2014/1
nct id: NCT02220816
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Within a prospective, randomised, controlled study 60, selected patients with chronic (> 6
      months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of
      competitive versus non-competitive attentional training. Competitive training will include
      fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations
      and fifteen 1-hour sessions of competitive attentional games designed for this purpose using
      a new virtual reality system (conventional liquid-crystal-display screen with an infrared LED
      array to facilitate multi-touch experience embedded in a conventional table). Progress will
      be evaluated by pre and post measurement of attentional neuropsychological tests, subjective
      reports of global attention, usability and motivational scales. Our hypothesis is that
      competitive training is more effective in improving attention than conventional training in
      the chronic phase after acquired brain injury.
Participants: Sixty 18-75 years-old patients with acquired brain injury, will be randomly
      assigned to 30 sessions of competitive versus non-competitive cognitive attentional training
      (see inclusion-exclusion criteria). Material and Methods: Randomized clinical trial comparing
      two different attentional training strategies. Attentional measures, usability data and
      caregiver/family perception of change, will be compared after completing both conditions.
      Competitive training will include a new computer based training program that involve using
      attentional skills under different competitive scenarios. Attentional exercises were designed
      according to the instructions of two experts neuropsychologists and included game-based
      situations simulating different olympic disciplines.Neuropsychological protocol: An
      assessment before the beginning of the intervention and pos-treatment will be done by a
      trained blinded neuropsychologist using measures of selective, sustained, divided and
      alternating attention (see primary outcome measures). Usability and Motivation: It is
      well-known that game-based cognitive exercises can increase motivation to treatment which in
      turn can increase learning strategies and improve outcomes after rehabilitation processes.
      Competitive tasks can also improve the effort and interest of the players and the intensity
      of the task through increasing motivation to win, get a reward and beat the others. Since
      motivation was an important element of our research, we assessed this capacity at the end of
      the treatment with the Intrinsic Motivation Scale. Also, the revised Competitiveness Index
      was used to measure the subject's preference for competitive situations. Finally, usability
      was considered a secondary outcome of our study since most of the games employed here were
      designed to be played in a new virtual reality system which was build to facilitate
      competitive strategies among 2-4 players (see secondary outcomes). Sample Size Calculation:
      There was any previous study that used the design proposed in this investigation. Considering
      a reduction bigger of 20% on the Hit-Reaction Time of the CPT-II scores in the active group
      intervention, sample size in both groups of 27 participants and standard-deviation in the
      magnitude of half of the medium score in each group (moderate variability), the study will be
      able to detect a moderate effect size (ES = 0,4). Calculating a sample loss of 10% each
      group, we define a sample size per group of 30 individuals. Statistical methods Statistical
      analyses will be performed with Statistical Package for the Social Sciences (SPSS) 12.0. The
      univariate analyses will be performed with the t student test / Mann-Whitney to continuous
      variables or Chi-Square test (X²) / Fischer test to categorical variables. The effective of
      the intervention over time will be assess through analyses of mixed models (repeated measures
      ANOVA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change in attentional psychometric measures
time frame: Baseline versus end of treatment (an expected average of 8 weeks)
description: Neuropsychological battery: Conner's Continuous Performance Test (CPT-II), Color-Trail Test, d2, Stroop test, Wechsler Adult Intelligence Scale-IV digit-span, Corsi block-tapping test
measure: Usability measures
time frame: Baseline versus end of treatment (an expected average of 8 weeks)
description: System Usability Scale, Intrinsic Motivation Inventory
measure: Family-centered outcomes
time frame: Baseline versus end of treatment (an expected average of 8 weeks)
description: Moos Attention Rating Scale, Subjective perception of improvement
arm group label: Competitive Training
arm group type: Experimental
description: The patients will receive only competitive activities designed to restore attention abilities. These include pencil-and-paper tasks completed under competitive circumstances and competitive virtual games specifically designed to treat different aspects of attention (divided, selective, sustained, etc).
arm group label: Non-Competitive Training
arm group type: Active Comparator
description: The patients will receive conventional attentional training. Pencil and paper tasks focused on different aspects of attention (divided, selective, sustained, etc.) will be completed by all participant under individual or group-therapy sessions. No competitive training will be allowed.
intervention type: Behavioral
intervention name: Competitive training
description: 30 sessions of competitive cognitive training; 3 - 5 sessions/week; duration 45 min
arm group label: Competitive Training
intervention type: Behavioral
intervention name: Non-Competitive Training
description: 30 sessions of non-competitive cognitive training; 3 - 5 sessions/week; duration 45 min
arm group label: Non-Competitive Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Roberto Llorens, PhD
role: Principal Investigator
affiliation: Universitat Politècnica de València
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Brain Injuries