<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/NCT03268304</url>
  </required_header>
  <id_info>
    <org_study_id>KAYO</org_study_id>
    <nct_id>NCT03268304</nct_id>
  </id_info>
  <brief_title>Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments</brief_title>
  <official_title>Feasibility of Two Novel Interactive Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments Using the YouGrabber Training System - the KAYO Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reha Rheinfelden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Reha Rheinfelden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: In the recent past, medical training systems using virtual reality (VR) have&#xD;
      been introduced to neurorehabilitation to train motor function deficits in patients. The&#xD;
      usage of VR-based training systems is based on the evidence of neuroplasticity, which is&#xD;
      responsible for recovery of patients suffering from motor dysfunction. Such systems are&#xD;
      increasingly used to encourage purposeful limb movements in a VR environment and its efficacy&#xD;
      has been found comparable with conventional therapeutic intervention. VR training systems,&#xD;
      e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential&#xD;
      to integrate valid and reliable assessment tools to monitor the recovery process.&#xD;
&#xD;
      Objectives: The aim of the clinical study is to evaluate the usability, feasibility and&#xD;
      validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as&#xD;
      a platform. Additionally, the feasibility and usability of the implementation of two&#xD;
      rehabilitation measures that only recently became integral part of neurorehabilitation, e.g.&#xD;
      Action Observation (AO) and Motor Imagery (MI), into the YG training software will be&#xD;
      evaluated. Patients &amp; methods: This observational study is designed as a single-arm trial for&#xD;
      testing the assessment software including pre- to post rehabilitation comparison of a&#xD;
      training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS,&#xD;
      Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75&#xD;
      patients will take part in the 4-week training on the enhanced VR-based system with a total&#xD;
      of 16 training sessions of 45 min each. Primary outcomes will be the score on the System&#xD;
      Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be&#xD;
      hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and&#xD;
      quality of life (EQ-5D-5L).&#xD;
&#xD;
      Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules&#xD;
      for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT&#xD;
      subscales will be implemented on the basis of the redesigned glove equipped with new sensors.&#xD;
      The results are expected to give recommendations for necessary modifications. They might also&#xD;
      contribute knowledge concerning the application of AO and MI tasks within VR training.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The software modules were not completed.&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cARAT</measure>
    <time_frame>17 weeks</time_frame>
    <description>Score on the conventional Action Research Arm Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>dARAT</measure>
    <time_frame>17 weeks</time_frame>
    <description>score on the digital ARAT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SUS</measure>
    <time_frame>15 weeks</time_frame>
    <description>System Usability Scale questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BBT</measure>
    <time_frame>17 weeks</time_frame>
    <description>Box and Block Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CAHAI</measure>
    <time_frame>17 weeks</time_frame>
    <description>Chedoke McMaster Arm and Hand Activity Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>17 weeks</time_frame>
    <description>EuroQol five dimensions questionnaire with five-level scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PGIC</measure>
    <time_frame>11 weeks</time_frame>
    <description>Patient Global Impression of change</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Stroke</condition>
  <condition>Parkinson Disease</condition>
  <condition>Traumatic Brain Injury</condition>
  <condition>Guillain-Barre Syndrome</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VR-based training including AO and MI</intervention_name>
    <description>Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. Patients will be recruited from the clinics' inpatient or outpatient departments by&#xD;
             physicians, therapists and nurses.&#xD;
&#xD;
          2. Patients will be recruited from the clinics' patient database. Datasets will be&#xD;
             screened for study selection criteria by the involved study personnel. If patients are&#xD;
             eligible, they will be sent a letter describing the study and including patient&#xD;
             information. If patients are interested in participating, they can contact the study&#xD;
             personnel in the clinic by phone or email.&#xD;
&#xD;
          3. Patients will be recruited via a study information flyer provided on the clinic's&#xD;
             homepage and through patient self-help groups. If patients are interested in&#xD;
             participating, they can contact the study personnel in the responsible clinic by phone&#xD;
             or email.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with motor function impairments of one or both upper limbs caused by&#xD;
             Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome&#xD;
&#xD;
          -  Able to sit in a normal chair without armrests&#xD;
&#xD;
          -  Able to score at least one in the Box and Block Test (BBT)&#xD;
&#xD;
          -  Comprehend German&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wrist-, hand- or finger contractures or an unconsolidated upper limb fracture&#xD;
&#xD;
          -  Severe cognitive deficits: Mini-Mental-Status-Test (MMSE) ≤ 20&#xD;
&#xD;
          -  Severe spatial-visual disorders, e.g. severe visual neglect&#xD;
&#xD;
          -  History of epileptic seizures triggered by visual stimuli (e.g. television, video&#xD;
             games) within the last six months&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
&#xD;
          -  Full score in the Chedoke Arm and Hand Activity Inventory (CAHAI) assessment&#xD;
&#xD;
          -  Brain pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Frank Behrendt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Reha Rheinfelden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Corina Schuster, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Reha Rheinfelden</affiliation>
  </overall_official>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Reha Rheinfelden</investigator_affiliation>
    <investigator_full_name>Frank Behrendt</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Upper Limb Motor Function Deficit</keyword>
  <keyword>Neurorehabilitation</keyword>
  <keyword>Virtual Reality</keyword>
  <keyword>Action Research Arm Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Guillain-Barre Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03268304
org study id: KAYO
nct id: NCT03268304
lead sponsor: 
has dmc: No
Introduction: In the recent past, medical training systems using virtual reality (VR) have
      been introduced to neurorehabilitation to train motor function deficits in patients. The
      usage of VR-based training systems is based on the evidence of neuroplasticity, which is
      responsible for recovery of patients suffering from motor dysfunction. Such systems are
      increasingly used to encourage purposeful limb movements in a VR environment and its efficacy
      has been found comparable with conventional therapeutic intervention. VR training systems,
      e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential
      to integrate valid and reliable assessment tools to monitor the recovery process.

      Objectives: The aim of the clinical study is to evaluate the usability, feasibility and
      validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as
      a platform. Additionally, the feasibility and usability of the implementation of two
      rehabilitation measures that only recently became integral part of neurorehabilitation, e.g.
      Action Observation (AO) and Motor Imagery (MI), into the YG training software will be
      evaluated. Patients & methods: This observational study is designed as a single-arm trial for
      testing the assessment software including pre- to post rehabilitation comparison of a
      training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS,
      Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75
      patients will take part in the 4-week training on the enhanced VR-based system with a total
      of 16 training sessions of 45 min each. Primary outcomes will be the score on the System
      Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be
      hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and
      quality of life (EQ-5D-5L).

      Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules
      for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT
      subscales will be implemented on the basis of the redesigned glove equipped with new sensors.
      The results are expected to give recommendations for necessary modifications. They might also
      contribute knowledge concerning the application of AO and MI tasks within VR training.
observational model: Cohort
time perspective: Prospective
measure: cARAT
time frame: 17 weeks
description: Score on the conventional Action Research Arm Test
measure: dARAT
time frame: 17 weeks
description: score on the digital ARAT
measure: SUS
time frame: 15 weeks
description: System Usability Scale questionnaire
measure: BBT
time frame: 17 weeks
description: Box and Block Test
measure: CAHAI
time frame: 17 weeks
description: Chedoke McMaster Arm and Hand Activity Inventory
measure: EQ-5D-5L
time frame: 17 weeks
description: EuroQol five dimensions questionnaire with five-level scale
measure: PGIC
time frame: 11 weeks
description: Patient Global Impression of change
intervention type: Other
intervention name: VR-based training including AO and MI
description: Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Frank Behrendt, PhD
role: Principal Investigator
affiliation: Reha Rheinfelden
last name: Corina Schuster, PhD
role: Principal Investigator
affiliation: Reha Rheinfelden
responsible party type: Principal Investigator
investigator affiliation: Reha Rheinfelden
investigator full name: Frank Behrendt
investigator title: Principal Investigator
mesh term: Parkinson Disease
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Guillain-Barre Syndrome
sharing ipd: Undecided