<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/NCT03766711</url>
  </required_header>
  <id_info>
    <org_study_id>H17-01126</org_study_id>
    <nct_id>NCT03766711</nct_id>
  </id_info>
  <brief_title>VR Error Augmentation for Bimanual Task Exercise</brief_title>
  <acronym>FEATHERSv2</acronym>
  <official_title>FEATHERS 2.0: Functional Engagement in Assistive Therapy Through Exercise Robotics v2.0</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kids Brain Health Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</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>
      This project is a continuing study from the FEATHERS project (NCT02290353) which focuses on&#xD;
      developing novel home therapy program for persons with hemiparesis. This study will focus on&#xD;
      examining motor behaviour and adaptation in neurodevelopmental hemiparesis (cerebral palsy,&#xD;
      acquired brain injury (ABI)). New algorithms for motion control involved in encouraging&#xD;
      active movement are developed and will be tested, but the study has the same therapeutic goal&#xD;
      and focus as the original FEATHERS project of creating an engaging at-home bimanual upper&#xD;
      limb training program. By incorporating existing gaming technology, we hope to discover novel&#xD;
      ways to adapt commercial motion tracking controllers and visual feedback into engaging&#xD;
      rehabilitative learning tools. This study will focus on a basic science aspect of human&#xD;
      bimanual movements that can be incorporated into future applications of the full FEATHERS&#xD;
      project devices. We believe that together these approaches will yield interventions that&#xD;
      significantly improve functional ability and lead to improved quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      (Main Phase Only - Data Collected with Clinical Population)&#xD;
&#xD;
      The FEATHERS project at the RREACH Lab at The University of British Columbia focuses on&#xD;
      developing and evaluating novel physical exercise technologies for kids with motor&#xD;
      disabilities. The study team would like to study how immersive virtual reality (VR)&#xD;
      technology can be used to benefit upper limb rehabilitation for persons with hemiplegia. The&#xD;
      purpose of the experiment is to see how the use of error augmentation (i.e. adding visual or&#xD;
      game element feedback to accentuate deviation from the desired exercise motion) might&#xD;
      encourage persons with hemiplegia to engage their affected side more effectively by comparing&#xD;
      the symmetry between the stronger and weaker limbs. It is also hypothesized that the&#xD;
      immersive environment of VR and the ability to provide 1:1 direct visual feedback will&#xD;
      increase active engagement to rehabilitative exercises in these populations. The study will&#xD;
      address the question of whether error augmentation aids in the rehabilitation of the affected&#xD;
      upper limb movement quality in hemiparesis when practicing bilateral reaching tasks.&#xD;
      Specifically, can visual amplification of paretic asymmetry in an immersive VR environment&#xD;
      improve movement quality in the affected side?&#xD;
&#xD;
      Adolescents and young adults with hemiplegia (i.e. due to ABI, CP, etc.) and their adjoining&#xD;
      therapists will be recruited for from the community. We will conduct testing in a&#xD;
      single-session setup at the participant chosen location with an easily transportable system&#xD;
      including a standard 2-3 sensor Oculus system hardware setup and software developed by the&#xD;
      research team. Sessions conducted outside the research lab rooms will require a minimum of a&#xD;
      2m x 1.5m space for calibration. The participants will test all augmentation factors in a&#xD;
      randomized order and the sessions are expected to take between 90-120 minutes. A short&#xD;
      post-session usability survey will be administered and sample population demographic data&#xD;
      will be recorded including age, gender, and handedness. Manual Ability Classification System&#xD;
      (MACS) and Bimanual Fine Motor Function (BFMF) scores will be recorded or assessed to&#xD;
      classify the upper limb motor ability of the sample set.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">September 24, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant intervention arm will be randomized and they will not be told which whether the treatment is being applied in the current set. However, they will be instructed of the task goal at the beginning of the session and will be told that we will be modifying visual feedback to help improve reaching symmetry in some manner.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Error in Forward Reaching Symmetry</measure>
    <time_frame>Recorded per reach, throughout the session (about 2 hours)</time_frame>
    <description>Compared between each condition (in cm, % change from baseline)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distance traveled of each arm from head</measure>
    <time_frame>Recorded per reach, throughout the session (about 2 hours)</time_frame>
    <description>Change in position in cm of the participant hands from the start to end of the reach trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to complete task</measure>
    <time_frame>Recorded per reach, throughout the session (about 2 hours)</time_frame>
    <description>Time in seconds from the start to the end of the reach trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Movement Smoothness</measure>
    <time_frame>Recorded per arm, per reach, throughout the session (about 2 hours)</time_frame>
    <description>Deviation from linear path in the lateral direction and number of peaks in forward velocity profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Error in Forward Reaching Symmetry Over Time</measure>
    <time_frame>Recorded per reach, throughout the session (about 2 hours)</time_frame>
    <description>Change in error throughout each set during the learning conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compensation Techniques Causing Joint Asymmetry</measure>
    <time_frame>Recorded throughout the session (about 2 hours)</time_frame>
    <description>Maximum difference in cm in contralateral joint position in the upper body (shoulder y, z)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trunk Compensation</measure>
    <time_frame>Recorded throughout the session (about 2 hours)</time_frame>
    <description>Change in forward position in cm of the participant head and trunk (mid-shoulder point) during reaching movement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Hemiparesis</condition>
  <condition>Cerebral Palsy</condition>
  <condition>Acquired Brain Injury</condition>
  <arm_group>
    <arm_group_label>Actual - Augmented</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reaching task as a physical therapy intervention. First with 1:1 visual feedback, then with augmented forward symmetry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Augmented - Actual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reaching task as a physical therapy intervention. First with augmented forward symmetry, then with 1:1 visual feedback.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <description>Repetitive bimanual task training for upper limb motor function recovery.</description>
    <arm_group_label>Actual - Augmented</arm_group_label>
    <arm_group_label>Augmented - Actual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion for adolescents and young adults (ages 13-21 years) :&#xD;
&#xD;
        i. Hemiplegia as a result of a neurological impairment (CP, ABI, paediatric stroke, etc.)&#xD;
&#xD;
        ii. Use both eyes and visually interact using a stereoscopic device that allows a minimum&#xD;
        interpupillary distance of 58mm&#xD;
&#xD;
        iii. Comfortably support regular head motion while wearing a 470g head-mounted display&#xD;
&#xD;
        iv. Ability to lift arms against gravity at least some distance away from their body (some&#xD;
        shoulder and elbow flexion and extension) as reported by participant, consenting guardian,&#xD;
        or adjoining therapist&#xD;
&#xD;
        v. Ability to stand or sit independently for 15 minutes at a time in a chair without arm&#xD;
        supports for a total of up to 120 minutes&#xD;
&#xD;
        vi. Ability to follow instructions and verbally communicate in basic English (as determined&#xD;
        by referring therapist)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i. Upper limb orthopedic surgery in the past six months&#xD;
&#xD;
        ii. Known susceptibility to cybersickness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hendrik FM Van der Loos, PhD, P.Eng</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physiotherapy, BC Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RREACH Lab, The University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Hendrik F. Machiel Van der Loos</investigator_full_name>
    <investigator_title>Associate Professor, Dept. Mechanical Engineering</investigator_title>
  </responsible_party>
  <keyword>Bimanual Task</keyword>
  <keyword>Motor Adaptation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Paresis</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/NCT03766711
org study id: H17-01126
nct id: NCT03766711
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project is a continuing study from the FEATHERS project (NCT02290353) which focuses on
      developing novel home therapy program for persons with hemiparesis. This study will focus on
      examining motor behaviour and adaptation in neurodevelopmental hemiparesis (cerebral palsy,
      acquired brain injury (ABI)). New algorithms for motion control involved in encouraging
      active movement are developed and will be tested, but the study has the same therapeutic goal
      and focus as the original FEATHERS project of creating an engaging at-home bimanual upper
      limb training program. By incorporating existing gaming technology, we hope to discover novel
      ways to adapt commercial motion tracking controllers and visual feedback into engaging
      rehabilitative learning tools. This study will focus on a basic science aspect of human
      bimanual movements that can be incorporated into future applications of the full FEATHERS
      project devices. We believe that together these approaches will yield interventions that
      significantly improve functional ability and lead to improved quality of life.
(Main Phase Only - Data Collected with Clinical Population)

      The FEATHERS project at the RREACH Lab at The University of British Columbia focuses on
      developing and evaluating novel physical exercise technologies for kids with motor
      disabilities. The study team would like to study how immersive virtual reality (VR)
      technology can be used to benefit upper limb rehabilitation for persons with hemiplegia. The
      purpose of the experiment is to see how the use of error augmentation (i.e. adding visual or
      game element feedback to accentuate deviation from the desired exercise motion) might
      encourage persons with hemiplegia to engage their affected side more effectively by comparing
      the symmetry between the stronger and weaker limbs. It is also hypothesized that the
      immersive environment of VR and the ability to provide 1:1 direct visual feedback will
      increase active engagement to rehabilitative exercises in these populations. The study will
      address the question of whether error augmentation aids in the rehabilitation of the affected
      upper limb movement quality in hemiparesis when practicing bilateral reaching tasks.
      Specifically, can visual amplification of paretic asymmetry in an immersive VR environment
      improve movement quality in the affected side?

      Adolescents and young adults with hemiplegia (i.e. due to ABI, CP, etc.) and their adjoining
      therapists will be recruited for from the community. We will conduct testing in a
      single-session setup at the participant chosen location with an easily transportable system
      including a standard 2-3 sensor Oculus system hardware setup and software developed by the
      research team. Sessions conducted outside the research lab rooms will require a minimum of a
      2m x 1.5m space for calibration. The participants will test all augmentation factors in a
      randomized order and the sessions are expected to take between 90-120 minutes. A short
      post-session usability survey will be administered and sample population demographic data
      will be recorded including age, gender, and handedness. Manual Ability Classification System
      (MACS) and Bimanual Fine Motor Function (BFMF) scores will be recorded or assessed to
      classify the upper limb motor ability of the sample set.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
masking description: Participant intervention arm will be randomized and they will not be told which whether the treatment is being applied in the current set. However, they will be instructed of the task goal at the beginning of the session and will be told that we will be modifying visual feedback to help improve reaching symmetry in some manner.
measure: Change in Error in Forward Reaching Symmetry
time frame: Recorded per reach, throughout the session (about 2 hours)
description: Compared between each condition (in cm, % change from baseline)
measure: Distance traveled of each arm from head
time frame: Recorded per reach, throughout the session (about 2 hours)
description: Change in position in cm of the participant hands from the start to end of the reach trial
measure: Time to complete task
time frame: Recorded per reach, throughout the session (about 2 hours)
description: Time in seconds from the start to the end of the reach trial
measure: Movement Smoothness
time frame: Recorded per arm, per reach, throughout the session (about 2 hours)
description: Deviation from linear path in the lateral direction and number of peaks in forward velocity profile
measure: Change in Error in Forward Reaching Symmetry Over Time
time frame: Recorded per reach, throughout the session (about 2 hours)
description: Change in error throughout each set during the learning conditions
measure: Compensation Techniques Causing Joint Asymmetry
time frame: Recorded throughout the session (about 2 hours)
description: Maximum difference in cm in contralateral joint position in the upper body (shoulder y, z)
measure: Trunk Compensation
time frame: Recorded throughout the session (about 2 hours)
description: Change in forward position in cm of the participant head and trunk (mid-shoulder point) during reaching movement
arm group label: Actual - Augmented
arm group type: Experimental
description: Reaching task as a physical therapy intervention. First with 1:1 visual feedback, then with augmented forward symmetry.
arm group label: Augmented - Actual
arm group type: Experimental
description: Reaching task as a physical therapy intervention. First with augmented forward symmetry, then with 1:1 visual feedback.
intervention type: Other
intervention name: Physical Therapy
description: Repetitive bimanual task training for upper limb motor function recovery.
arm group label: Actual - Augmented
arm group label: Augmented - Actual
criteria: 
gender: All
minimum age: 13 Years
maximum age: 21 Years
healthy volunteers: No
last name: Hendrik FM Van der Loos, PhD, P.Eng
role: Principal Investigator
affiliation: The University of British Columbia
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Hendrik F. Machiel Van der Loos
investigator title: Associate Professor, Dept. Mechanical Engineering
mesh term: Brain Injuries
mesh term: Cerebral Palsy
mesh term: Paresis