xml: <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/NCT05967078</url>
    </required_header>
    <id_info>
      <org_study_id>2022-00559</org_study_id>
      <nct_id>NCT05967078</nct_id>
    </id_info>
    <brief_title>ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study</brief_title>
    <acronym>ExerGetic</acronym>
    <official_title>ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Frank Behrendt</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Innosuisse - Swiss Innovation Agency</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Reha Rheinfelden</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>
        Video game-based training programs, in the following referred to as &quot;exergames&quot; are an&#xD;
        innovative digital training approach to simultaneously train physical and cognitive functions&#xD;
        and increase training motivation for various populations. Patients who are differently&#xD;
        limited in their physical and cognitive performance due to a decline in functioning can&#xD;
        profit from a motivating and combined physical-cognitive training approach. An&#xD;
        interdisciplinary team of movement scientists, sports and training experts, as well as game&#xD;
        and industrial designers developed an innovative and immersive video game-based training&#xD;
        product for patients - the ExerCube training software licence. The exergame development&#xD;
        focused on a user-centred process together with the target population.&#xD;
  &#xD;
        The ExerCube training software licence is an exergame training product that includes&#xD;
        immersive mixed-reality training programs (or video games) for patients. Depending on the&#xD;
        patient's training requirements, the therapists can choose from the training program&#xD;
        repertoire. The patients control the training program (or video game) by specific (whole)&#xD;
        body movements. To present the virtual training programs from the ExerCube training software&#xD;
        licence in the physical environment, the ExerCube hardware and harness system is used to&#xD;
        serve as a physical training room. It allows the virtual video game environment to be&#xD;
        presented in the physical world.&#xD;
  &#xD;
        This summative usability study aims to assess the training system's safety, usability and&#xD;
        validate the user experience.&#xD;
  &#xD;
        Primary end-users (defined as patients aged 18 and above) and secondary end-users (defined as&#xD;
        sports scientists, training therapists or physiotherapists/occupational therapists with a&#xD;
        focus on sports/training therapy) will test and review the system in different testing&#xD;
        scenarios.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 16, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Usability: performance rate</measure>
      <time_frame>1 day</time_frame>
      <description>The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round.&#xD;
  Primary end users (PEU): acceptance criteria for performance = correct task performance &quot;yes&quot; ≥ 85%, skipped tasks &lt; 20%&#xD;
  Secondary end users (SEU): acceptance criteria for performance = task performed correctly or with hesitant behaviour ≥ 85%, task not performed or with difficulties and failures &lt; 15%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Usability: Number of participants with no need for support</measure>
      <time_frame>1 day</time_frame>
      <description>The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round.&#xD;
  Primary end users (PEU): acceptance criteria for comprehensibility = very good or good comprehension about how to perform the task ≥ 85%&#xD;
  Secondary end users (SEU): acceptance criteria for support = task performed without support ≥ 85%, support needed to be able to complete the task &lt; 15%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Usability: exercise execution</measure>
      <time_frame>1 day</time_frame>
      <description>The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round.&#xD;
  Primary end users (PEU):&#xD;
  - acceptance criteria for exercise execution = very good or good exercise/ movement execution ≥ 85%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Usability: Number of (serious) adverse events</measure>
      <time_frame>1 day</time_frame>
      <description>(Serious) Adverse Events: acceptance criteria of occurrence of related adverse events should not exceed 10%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Usability: device deficiencies</measure>
      <time_frame>1 day</time_frame>
      <description>Acceptance criteria for occurence of any device deficiencies encountered during study visits is set to &lt;10%.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Usability: Player Experience</measure>
      <time_frame>1 day</time_frame>
      <description>Primary end users (PEUs): The user experience will be assessed with the Player Experience Inventory (PXI), a 30 item questionnaire containing 10 different constructs to measure different aspects of player experience (three items per construct). All items are rated on a 7-point Likert scale (scale range: -3 to 3 points, maximal score = +90; minimal score: -90).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability: System Usability</measure>
      <time_frame>1 day</time_frame>
      <description>Secondary end users (SEUs): The System Usability Scale (SUS) will be completed by secondary end users to evaluate the perceived usability. SUS assesses perceived effectiveness (can users successfully achieve their objectives), information quality (how much effort and resource is expended in achieving those objectives) and general satisfaction (was the experience satisfactory). The SUS hast 10 items that can be rated on a 5-point likert scale. The items will be scored as follows:&#xD;
  For odd-numbered items, user response-1. For even-numbered items 5-user response. This scales all values from 0 to 4 (with four being the most positive response). Ref: Jeff Sauro, measuring usability&#xD;
  Add up the converted responses for each user and multiply that total by 2.5 (to convert the range of possible values from 0 to 100 instead of from 0 to 40)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived physical and mental exertion/ effort</measure>
      <time_frame>1 day</time_frame>
      <description>Perceived physical exertion during the training will be assessed with the Borg-category rating 10 (Borg CR10; scale range from 0= no exertion at all, 10= maximal level of exertion).&#xD;
  Perceived mental effort will be assessed from primary end users with the Paas mental effort scale (Paas, 1992) ranging from 1= very, very low mental effort, 9=very, very high mental effort.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Gait Disorders, Neurologic</condition>
    <condition>Gait Disorders in Old Age</condition>
    <condition>Gait Disorder, Sensorimotor</condition>
    <condition>Balance; Distorted</condition>
    <condition>Functional Movement Disorder</condition>
    <condition>Visual Disorder</condition>
    <condition>Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Test group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The device under investigation is the ExerCube training software licence provided by Sphery (https://sphery.ch/exercube/). The ExerCube training software licence is an exergame training product that includes immersive mixed-reality training programs (or video games) for patients. Depending on the patient's training requirements, the therapists can choose from the training program repertoire. The ExerCube supporting material for safety consisting of a harness and an over-head gantry system ensures a safe training environment and prevents patients from falling.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ExerG</intervention_name>
      <description>The intervention for primary end users (PEU, (patients)) includes the performance of two training rounds with the device. The first round includes a predefined training sequence, whereas the second round is a training sequence defined by the therapist.&#xD;
  For the secondary end user group (SEU, (therapists)), there are two study visits. At their first visit they get an introduction and training on how to use the system. At their second visit, SEU will have to prepare the device (switch on hard- and software) and guide the patient through the training.</description>
      <arm_group_label>Test group</arm_group_label>
      <other_name>ExerG training software licence</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Primary end users:&#xD;
  &#xD;
            -  in-/ or outpatients of the Reha Rheinfelden&#xD;
  &#xD;
            -  Ability to speak and comprehend German and to understand the digitally transmitted&#xD;
               training instructions&#xD;
  &#xD;
            -  Body height ≥ 160 cm or ≤ 200 cm according to hardware specifications&#xD;
  &#xD;
            -  Body weight ≤ 120 kg&#xD;
  &#xD;
            -  Able to execute the movements of the video game-based training (being able to transfer&#xD;
               from a sitting to a standing position and maintain the standing position without&#xD;
               assistance for ≥ 2 minutes)&#xD;
  &#xD;
          Secondary end users:&#xD;
  &#xD;
            -  therapists (physiotherapist, occupational therapist, sport scientist, sport therapist,&#xD;
               psychologists) working in the area of rehabilitation and prevention&#xD;
  &#xD;
            -  ≥ 21 years of age&#xD;
  &#xD;
            -  Bachelor's degree (scientists) or completed education as therapist&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Primary end users&#xD;
  &#xD;
            -  Cognitive impairment as defined by a Mini Mental State Examination (MMSE) score of ≤&#xD;
               18&#xD;
  &#xD;
            -  Severe visual, neurological, cardiorespiratory, psychiatric, or orthopedic impairments&#xD;
               which reduce the person's capability of following the instructions or to play the game&#xD;
  &#xD;
            -  Recently occurred epileptic seizures (in the past 3 months)&#xD;
  &#xD;
            -  Recent surgery/fractures/surgical interventions/joint replacement and malignancy (in&#xD;
               the past 3 months)&#xD;
  &#xD;
            -  Physical conditions in which a correct wearing of the Safety harness is not possible&#xD;
               or could cause pain or health problems (e.g. skin lesions, open wounds, known&#xD;
               pregnancy, severe osteoporosis)&#xD;
  &#xD;
            -  Joint contractures (e.g. shoulder, knee, hip) that could lead to limitations during&#xD;
               end-user evaluation of the ExerCube.&#xD;
  &#xD;
            -  Severe neurologic illness (e.g., strong epilepsy, advanced parkinson's syndrome,&#xD;
               condition after severe stroke)&#xD;
  &#xD;
            -  Severe psychiatric illness (e.g., pronounced paranoid states, severe depression)&#xD;
  &#xD;
            -  Terminal illness (prognosis &lt; 12 months)&#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>Frank Behrendt, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Reha Rheinfelden</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Frank Behrendt, PhD</last_name>
      <phone>+41 61 836 5387</phone>
      <email>f.behrendt@reha-rhf.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Silvia Herren, MSc</last_name>
      <phone>+41 61 836 5388</phone>
      <email>s.herren@reha-rhf.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Reha Rheinfelden</name>
        <address>
          <city>Rheinfelden</city>
          <state>Aargau</state>
          <zip>4310</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silvia Herren</last_name>
        <phone>+41 61 836 5388</phone>
        <email>s.herren@reha-rhf.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Reha Rheinfelden</investigator_affiliation>
      <investigator_full_name>Frank Behrendt</investigator_full_name>
      <investigator_title>Sponsor-Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Movement Disorders</mesh_term>
      <mesh_term>Nervous System Diseases</mesh_term>
      <mesh_term>Gait Disorders, Neurologic</mesh_term>
      <mesh_term>Vision Disorders</mesh_term>
      <mesh_term>Conversion Disorder</mesh_term>
      <mesh_term>Hysteria</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967078
  org study id: 2022-00559
  nct id: NCT05967078
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Video game-based training programs, in the following referred to as "exergames" are an
        innovative digital training approach to simultaneously train physical and cognitive functions
        and increase training motivation for various populations. Patients who are differently
        limited in their physical and cognitive performance due to a decline in functioning can
        profit from a motivating and combined physical-cognitive training approach. An
        interdisciplinary team of movement scientists, sports and training experts, as well as game
        and industrial designers developed an innovative and immersive video game-based training
        product for patients - the ExerCube training software licence. The exergame development
        focused on a user-centred process together with the target population.
  
        The ExerCube training software licence is an exergame training product that includes
        immersive mixed-reality training programs (or video games) for patients. Depending on the
        patient's training requirements, the therapists can choose from the training program
        repertoire. The patients control the training program (or video game) by specific (whole)
        body movements. To present the virtual training programs from the ExerCube training software
        licence in the physical environment, the ExerCube hardware and harness system is used to
        serve as a physical training room. It allows the virtual video game environment to be
        presented in the physical world.
  
        This summative usability study aims to assess the training system's safety, usability and
        validate the user experience.
  
        Primary end-users (defined as patients aged 18 and above) and secondary end-users (defined as
        sports scientists, training therapists or physiotherapists/occupational therapists with a
        focus on sports/training therapy) will test and review the system in different testing
        scenarios.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Usability: performance rate
  time frame: 1 day
  description: The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round.
  Primary end users (PEU): acceptance criteria for performance = correct task performance "yes" ≥ 85%, skipped tasks < 20%
  Secondary end users (SEU): acceptance criteria for performance = task performed correctly or with hesitant behaviour ≥ 85%, task not performed or with difficulties and failures < 15%
  measure: Usability: Number of participants with no need for support
  time frame: 1 day
  description: The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round.
  Primary end users (PEU): acceptance criteria for comprehensibility = very good or good comprehension about how to perform the task ≥ 85%
  Secondary end users (SEU): acceptance criteria for support = task performed without support ≥ 85%, support needed to be able to complete the task < 15%
  measure: Usability: exercise execution
  time frame: 1 day
  description: The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round.
  Primary end users (PEU):
  - acceptance criteria for exercise execution = very good or good exercise/ movement execution ≥ 85%
  measure: Usability: Number of (serious) adverse events
  time frame: 1 day
  description: (Serious) Adverse Events: acceptance criteria of occurrence of related adverse events should not exceed 10%.
  measure: Usability: device deficiencies
  time frame: 1 day
  description: Acceptance criteria for occurence of any device deficiencies encountered during study visits is set to <10%.
  measure: Usability: Player Experience
  time frame: 1 day
  description: Primary end users (PEUs): The user experience will be assessed with the Player Experience Inventory (PXI), a 30 item questionnaire containing 10 different constructs to measure different aspects of player experience (three items per construct). All items are rated on a 7-point Likert scale (scale range: -3 to 3 points, maximal score = +90; minimal score: -90).
  measure: Usability: System Usability
  time frame: 1 day
  description: Secondary end users (SEUs): The System Usability Scale (SUS) will be completed by secondary end users to evaluate the perceived usability. SUS assesses perceived effectiveness (can users successfully achieve their objectives), information quality (how much effort and resource is expended in achieving those objectives) and general satisfaction (was the experience satisfactory). The SUS hast 10 items that can be rated on a 5-point likert scale. The items will be scored as follows:
  For odd-numbered items, user response-1. For even-numbered items 5-user response. This scales all values from 0 to 4 (with four being the most positive response). Ref: Jeff Sauro, measuring usability
  Add up the converted responses for each user and multiply that total by 2.5 (to convert the range of possible values from 0 to 100 instead of from 0 to 40)
  measure: Perceived physical and mental exertion/ effort
  time frame: 1 day
  description: Perceived physical exertion during the training will be assessed with the Borg-category rating 10 (Borg CR10; scale range from 0= no exertion at all, 10= maximal level of exertion).
  Perceived mental effort will be assessed from primary end users with the Paas mental effort scale (Paas, 1992) ranging from 1= very, very low mental effort, 9=very, very high mental effort.
  arm group label: Test group
  arm group type: Experimental
  description: The device under investigation is the ExerCube training software licence provided by Sphery (https://sphery.ch/exercube/). The ExerCube training software licence is an exergame training product that includes immersive mixed-reality training programs (or video games) for patients. Depending on the patient's training requirements, the therapists can choose from the training program repertoire. The ExerCube supporting material for safety consisting of a harness and an over-head gantry system ensures a safe training environment and prevents patients from falling.
  intervention type: Device
  intervention name: ExerG
  description: The intervention for primary end users (PEU, (patients)) includes the performance of two training rounds with the device. The first round includes a predefined training sequence, whereas the second round is a training sequence defined by the therapist.
  For the secondary end user group (SEU, (therapists)), there are two study visits. At their first visit they get an introduction and training on how to use the system. At their second visit, SEU will have to prepare the device (switch on hard- and software) and guide the patient through the training.
  arm group label: Test group
  other name: ExerG training software licence
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Frank Behrendt, PhD
  role: Principal Investigator
  affiliation: Reha Rheinfelden
  last name: Frank Behrendt, PhD
  phone: +41 61 836 5387
  email: f.behrendt@reha-rhf.ch
  last name: Silvia Herren, MSc
  phone: +41 61 836 5388
  email: s.herren@reha-rhf.ch
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor-Investigator
  investigator affiliation: Reha Rheinfelden
  investigator full name: Frank Behrendt
  investigator title: Sponsor-Investigator
  mesh term: Movement Disorders
  mesh term: Nervous System Diseases
  mesh term: Gait Disorders, Neurologic
  mesh term: Vision Disorders
  mesh term: Conversion Disorder
  mesh term: Hysteria
  sharing ipd: No