<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/NCT02257125</url>
  </required_header>
  <id_info>
    <org_study_id>EKNZ (LU) 13079</org_study_id>
    <nct_id>NCT02257125</nct_id>
  </id_info>
  <brief_title>ArmeoSenso - Reward</brief_title>
  <official_title>ArmeoSenso - Rewarding vs. Non-rewarding Therapy of Patients With Arm Impairments Based on Wearable Movement Sensors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cereneo AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cereneo AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the use of motivating/rewarding features in a computer based arm&#xD;
      rehabilitation program. Half of the subjects will take part, besides receiving standard&#xD;
      therapy, in a computer based program delivering a game like scenario with visual effects and&#xD;
      monetary rewards in case of successful level completion, while the other half will take part&#xD;
      in a similar program without visual effects or the possibility to earn money.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rewards not only increase motivation to train, but have also been shown to influence motor&#xD;
      skill learning via activation of dopaminergic brain structures. In goal oriented tasks,&#xD;
      receiving information about goal achievement has a rewarding value, which is further&#xD;
      increased if performance has monetary consequences. Computer games often strengthen this kind&#xD;
      of information by presenting explosions and other salient stimuli when a goal is achieved&#xD;
      (e.g. a target has been reached). The current study investigates the outcome of an arm&#xD;
      rehabilitation program, based on such a computer game delivered in two versions. Stroke&#xD;
      patients are asked to use their impaired arms to perform goal oriented movements. Movements&#xD;
      are translated into movements of a virtual arm on a computer screen. Goals are &quot;meteors&quot;,&#xD;
      threatening to destroy a planet on which they fall, if not caught by the virtual arm. One&#xD;
      version of the computer game delivers state of the art graphics including a number of visual&#xD;
      effects and, if the planet was protected successfully, information about a monetary reward,&#xD;
      whereas the other version of the program delivers schematic graphic objects only. Training&#xD;
      time and intensity are kept constant and outcome measures, including standard clinical motor&#xD;
      assessments, are compared between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Stopped due to futility considerations:&#xD;
&#xD;
    Sample size calculations have assumed smaller effect sizes than considered relevant now.&#xD;
  </why_stopped>
  <start_date type="Actual">January 27, 2015</start_date>
  <completion_date type="Actual">October 28, 2019</completion_date>
  <primary_completion_date type="Actual">October 28, 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ArmeoSenso - hand workspace</measure>
    <time_frame>Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22): Main outcome is the change in hand workspace over the training intervention.</time_frame>
    <description>The subject moves the affected arm as far as possible in all directions while sitting in a gaming position. Movement range is recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motivation questionnaire</measure>
    <time_frame>Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)</time_frame>
    <description>Measures motivation to train.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wolf Motor Function Test</measure>
    <time_frame>Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)</time_frame>
    <description>Quantifies upper extremity motor ability through timed and functional tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment Upper Extremity</measure>
    <time_frame>Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)</time_frame>
    <description>Measures motor impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Blocks Test</measure>
    <time_frame>Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)</time_frame>
    <description>Measures gross manual dexterity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ArmeoSenso: pointing task</measure>
    <time_frame>Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)</time_frame>
    <description>Goal is to reach targets in the transversal plane in front of the subject: number of targets and time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log 14 (MAL-14)</measure>
    <time_frame>Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)</time_frame>
    <description>Self-reported movement ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index</measure>
    <time_frame>Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)</time_frame>
    <description>Measure of independence in daily living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS</measure>
    <time_frame>Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)</time_frame>
    <description>Measure of stroke severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>high incentive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>game version including visual effects and monetary rewards</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low incentive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>game version without visual effects or monetary rewards</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>high incentive</intervention_name>
    <description>Subjects are required to use their arms in order to control a virtual arm on a computer screen to prevent meteors from destroying a planet. The game includes visual effects and monetary rewards.</description>
    <arm_group_label>high incentive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>low incentive</intervention_name>
    <description>Subjects are required to use their arms in order to control a virtual &quot;hand&quot; on a computer screen to prevent objects from reaching the bottom. The game does not include visual effects or monetary rewards.</description>
    <arm_group_label>low incentive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stroke survivor (max. 100 days post-stroke)&#xD;
&#xD;
          -  upper extremity motor deficits&#xD;
&#xD;
          -  patient can lift the paretic arm against gravity&#xD;
&#xD;
          -  patient can move the hand at least 20x20 cm in a horizontal plane&#xD;
&#xD;
          -  patient is able and willing to participate&#xD;
&#xD;
          -  patient has signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe aphasia (impairing verbal instructions)&#xD;
&#xD;
          -  severe dementia (impairing the capability to understand instructions)&#xD;
&#xD;
          -  severe depression (impairing motivation to train)&#xD;
&#xD;
          -  relevant (in the judgement of the investigator) impairment of visual perception,&#xD;
             (impairing perception of goals and feedback on the computer screen)&#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>Andreas Luft, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich, University Hospital Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cereneo, Center For Rehabilitation and Neurology</name>
      <address>
        <city>Vitznau</city>
        <state>Lucerne</state>
        <zip>6354</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Adelheid</name>
      <address>
        <city>Unterägeri</city>
        <state>Zug</state>
        <zip>6314</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuercher Reha Zentrum Wald</name>
      <address>
        <city>Wald</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>virtual reality</keyword>
  <keyword>stroke</keyword>
  <keyword>upper extremity</keyword>
  <keyword>arm</keyword>
  <keyword>feedback</keyword>
  <keyword>reward</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02257125
org study id: EKNZ (LU) 13079
nct id: NCT02257125
lead sponsor: 
collaborator: 
has dmc: No
This study investigates the use of motivating/rewarding features in a computer based arm
      rehabilitation program. Half of the subjects will take part, besides receiving standard
      therapy, in a computer based program delivering a game like scenario with visual effects and
      monetary rewards in case of successful level completion, while the other half will take part
      in a similar program without visual effects or the possibility to earn money.
Rewards not only increase motivation to train, but have also been shown to influence motor
      skill learning via activation of dopaminergic brain structures. In goal oriented tasks,
      receiving information about goal achievement has a rewarding value, which is further
      increased if performance has monetary consequences. Computer games often strengthen this kind
      of information by presenting explosions and other salient stimuli when a goal is achieved
      (e.g. a target has been reached). The current study investigates the outcome of an arm
      rehabilitation program, based on such a computer game delivered in two versions. Stroke
      patients are asked to use their impaired arms to perform goal oriented movements. Movements
      are translated into movements of a virtual arm on a computer screen. Goals are "meteors",
      threatening to destroy a planet on which they fall, if not caught by the virtual arm. One
      version of the computer game delivers state of the art graphics including a number of visual
      effects and, if the planet was protected successfully, information about a monetary reward,
      whereas the other version of the program delivers schematic graphic objects only. Training
      time and intensity are kept constant and outcome measures, including standard clinical motor
      assessments, are compared between the groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in ArmeoSenso - hand workspace
time frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22): Main outcome is the change in hand workspace over the training intervention.
description: The subject moves the affected arm as far as possible in all directions while sitting in a gaming position. Movement range is recorded.
measure: Motivation questionnaire
time frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
description: Measures motivation to train.
measure: Wolf Motor Function Test
time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
description: Quantifies upper extremity motor ability through timed and functional tasks.
measure: Fugl-Meyer Assessment Upper Extremity
time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
description: Measures motor impairment.
measure: Box and Blocks Test
time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
description: Measures gross manual dexterity.
measure: ArmeoSenso: pointing task
time frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
description: Goal is to reach targets in the transversal plane in front of the subject: number of targets and time.
measure: Motor Activity Log 14 (MAL-14)
time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
description: Self-reported movement ability.
measure: Barthel Index
time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
description: Measure of independence in daily living.
measure: NIHSS
time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
description: Measure of stroke severity.
arm group label: high incentive
arm group type: Experimental
description: game version including visual effects and monetary rewards
arm group label: low incentive
arm group type: Active Comparator
description: game version without visual effects or monetary rewards
intervention type: Behavioral
intervention name: high incentive
description: Subjects are required to use their arms in order to control a virtual arm on a computer screen to prevent meteors from destroying a planet. The game includes visual effects and monetary rewards.
arm group label: high incentive
intervention type: Behavioral
intervention name: low incentive
description: Subjects are required to use their arms in order to control a virtual "hand" on a computer screen to prevent objects from reaching the bottom. The game does not include visual effects or monetary rewards.
arm group label: low incentive
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Luft, Prof.
role: Principal Investigator
affiliation: University of Zurich, University Hospital Zurich
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Stroke