<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/NCT03300141</url>
  </required_header>
  <id_info>
    <org_study_id>STU00204661</org_study_id>
    <nct_id>NCT03300141</nct_id>
  </id_info>
  <brief_title>Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback</brief_title>
  <official_title>Bimanual Balanced Reaching With Visual Biofeedback</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shirley Ryan AbilityLab</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>
      The goal of this research study is to increase understanding of error augmentation by&#xD;
      applying it to visual feedback during motion tracking with a Leap Motion device - a recently&#xD;
      developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality&#xD;
      environment.&#xD;
&#xD;
      In conjunction with the Leap, large, three dimensional work spaces can provide an immersive&#xD;
      and virtual augmented environment for rehabilitation. Previously, experiments have utilized&#xD;
      the Virtual Reality Robotic and Optical Operations Machine (VRROOM) to create such visually&#xD;
      immersive environments. The Robotics lab as part of the Arms and Hands Lab on the 22nd floor&#xD;
      of the Shirley Ryan Abilitylab has developed a portable version of this system, which is more&#xD;
      compact and clinic-compatible. Combining this visual 3D system with the Leap creates a novel,&#xD;
      more capable apparatus for studying error augmentation.&#xD;
&#xD;
      This research study will have 3 different arms: 1.) a healthy group of individuals (Healthy&#xD;
      Arm), 2.) a group of stroke survivors within 8 months of stroke (Acute Arm), and 3.) a group&#xD;
      of stroke survivors that had their stroke more than 8 months ago (Chronic Arm).&#xD;
&#xD;
      Each Arm will use the Leap motion tracker and the Looking Glass to participate in a reaching&#xD;
      intervention. The healthy arm will only participate in 1 visit with an intervention with and&#xD;
      without error augmented visual feedback. The Acute Arm and the Chronic Arm will both have 2&#xD;
      groups: 1.) Error Augmented Visual Feedback group and 2.) Non-Augmented or Veridical Visual&#xD;
      Feedback group.&#xD;
&#xD;
      The Chronic Arm will have a structured intervention and evaluation protocol: Study staff will&#xD;
      administer outcome assessments at 3 time points: a.) prior to intervention, b.) post&#xD;
      intervention, and c.) 2 months after the conclusion of intervention. Intervention will occur&#xD;
      over the span of 6-8 weeks with the goal of 3 1-hour sessions per week.&#xD;
&#xD;
      The Acute Arm will have a less structured intervention that will occur while the participant&#xD;
      is an inpatient at Shirley Ryan AbilityLab. Study staff will administer outcome assessments&#xD;
      at at least 2 time points: a.) prior to intervention, b.) post intervention just prior to&#xD;
      discharge from Shirley Ryan AbilityLab. Between initial and post intervention evaluations,&#xD;
      midpoint evaluations will take place at a maximum of once per week if the participant's&#xD;
      schedule, activity tolerance, and length of stay allows. Intervention will consist of 1-hour&#xD;
      sessions occurring according to the availability of the participant at the rate of no more&#xD;
      than 2 sessions in a 24 hour period.&#xD;
&#xD;
      Investigators hope to investigate these questions:&#xD;
&#xD;
        1. Can the movement of healthy individuals be characterized with error augmented visual&#xD;
           feedback and veridical visual feedback?&#xD;
&#xD;
        2. Will error augmented visual feedback or veridical visual feedback result in greater&#xD;
           movement ability improvement?&#xD;
&#xD;
           Investigators hypothesize that in the Chronic Arm, those what trained with&#xD;
           error-augmented visual feedback will have improved movement ability compared to those&#xD;
           who trained with veridical visual feedback.&#xD;
&#xD;
        3. Is treatment with the looking glass and leap system feasible with an inpatient&#xD;
           population?&#xD;
&#xD;
      Investigators hypothesize that this treatment will be feasible for an inpatient population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Fugl Meyer Upper Extremity Score: Pre to Post/Discharge - Chronic and Acute Arms</measure>
    <time_frame>1-3 weeks for acute arm; 9 weeks for chronic arm</time_frame>
    <description>Change in Fugl Meyer score from pre-evaluation to post -evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl Meyer Upper Extremity Score: Pre to Follow-up</measure>
    <time_frame>4.5 months</time_frame>
    <description>Change in Fugl Meyer score from pre-evaluation to follow-up-evaluation - Chronic Arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of use</measure>
    <time_frame>1-3 weeks, on average</time_frame>
    <description>Time spent in treatment - Acute Arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test Score: Pre to Post</measure>
    <time_frame>1-3 weeks for acute arm; 9 weeks for chronic arm</time_frame>
    <description>Change in Action Research Arm Test score from pre-evaluation to post -evaluation: Chronic and Acute Arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test Score: Pre to Follow-Up</measure>
    <time_frame>4.5 months</time_frame>
    <description>Change in Action Research Arm Test score from pre-evaluation to Follow-up -evaluation: Chronic Arm</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Stroke</condition>
  <condition>Stroke, Acute</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Veridical Visual Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Augmented Visual Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute Veridical Visual Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute Augmented Visual Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Veridical Visual Feedback</intervention_name>
    <description>Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.</description>
    <arm_group_label>Acute Veridical Visual Feedback</arm_group_label>
    <arm_group_label>Chronic Veridical Visual Feedback</arm_group_label>
    <other_name>Reaching</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Augmented Visual Feedback</intervention_name>
    <description>Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.</description>
    <arm_group_label>Acute Augmented Visual Feedback</arm_group_label>
    <arm_group_label>Chronic Augmented Visual Feedback</arm_group_label>
    <other_name>Reaching</other_name>
    <other_name>Error Augmentation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Comparative Reaching Task</intervention_name>
    <description>Reaching while sitting at the Looking Glass system. This will occur over the course of 1 hour.</description>
    <arm_group_label>Healthy</arm_group_label>
    <other_name>Healthy Reaching</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  8 months post stroke&#xD;
&#xD;
          -  FMUE 15-50&#xD;
&#xD;
          -  Active shoulder and elbow flexion-extension when supported against gravity to&#xD;
             accomplish a forward mediolateral and inferior-superior reaching movements of 30 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral paresis&#xD;
&#xD;
          -  Severe sensory deficits in the affected limb&#xD;
&#xD;
          -  Severe spasticity preventing movement (MAS 4 or greater at elbow)&#xD;
&#xD;
          -  Aphasia, cognitive impairment or affective dysfunction that influence ability to&#xD;
             participate in the experiment&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Severe current medical problems&#xD;
&#xD;
          -  Diffuse/multiple lesion sites or multiple strokes&#xD;
&#xD;
          -  Hemi-spatial neglect or visual field cut preventing subjects from seeing the target&#xD;
&#xD;
          -  Inability to maintain the testing positions&#xD;
&#xD;
          -  Botox injections in the affected Upper Extremity within the past 4 months&#xD;
&#xD;
          -  Concurrent participation in Upper Extremity rehab (research or prescribed therapy)&#xD;
&#xD;
          -  Participation in previous, similar robotics intervention studies&#xD;
&#xD;
          -  Pregnant women, children and teenagers, prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Patton</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Courtney Celian, MSOT</last_name>
    <phone>312-238-1560</phone>
    <email>ccelian@sralab.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shirley Ryan AbilityLab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Courtney Celian, MSOT</last_name>
      <phone>312-238-1560</phone>
      <email>ccelian@sralab.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>James Patton</investigator_full_name>
    <investigator_title>Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab</investigator_title>
  </responsible_party>
  <keyword>Upper Extremity</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Arm</keyword>
  <keyword>Robotics</keyword>
  <keyword>Stroke Rehabilitation</keyword>
  <keyword>Virtual Reality Thearpy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03300141
org study id: STU00204661
nct id: NCT03300141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to increase understanding of error augmentation by
      applying it to visual feedback during motion tracking with a Leap Motion device - a recently
      developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality
      environment.

      In conjunction with the Leap, large, three dimensional work spaces can provide an immersive
      and virtual augmented environment for rehabilitation. Previously, experiments have utilized
      the Virtual Reality Robotic and Optical Operations Machine (VRROOM) to create such visually
      immersive environments. The Robotics lab as part of the Arms and Hands Lab on the 22nd floor
      of the Shirley Ryan Abilitylab has developed a portable version of this system, which is more
      compact and clinic-compatible. Combining this visual 3D system with the Leap creates a novel,
      more capable apparatus for studying error augmentation.

      This research study will have 3 different arms: 1.) a healthy group of individuals (Healthy
      Arm), 2.) a group of stroke survivors within 8 months of stroke (Acute Arm), and 3.) a group
      of stroke survivors that had their stroke more than 8 months ago (Chronic Arm).

      Each Arm will use the Leap motion tracker and the Looking Glass to participate in a reaching
      intervention. The healthy arm will only participate in 1 visit with an intervention with and
      without error augmented visual feedback. The Acute Arm and the Chronic Arm will both have 2
      groups: 1.) Error Augmented Visual Feedback group and 2.) Non-Augmented or Veridical Visual
      Feedback group.

      The Chronic Arm will have a structured intervention and evaluation protocol: Study staff will
      administer outcome assessments at 3 time points: a.) prior to intervention, b.) post
      intervention, and c.) 2 months after the conclusion of intervention. Intervention will occur
      over the span of 6-8 weeks with the goal of 3 1-hour sessions per week.

      The Acute Arm will have a less structured intervention that will occur while the participant
      is an inpatient at Shirley Ryan AbilityLab. Study staff will administer outcome assessments
      at at least 2 time points: a.) prior to intervention, b.) post intervention just prior to
      discharge from Shirley Ryan AbilityLab. Between initial and post intervention evaluations,
      midpoint evaluations will take place at a maximum of once per week if the participant's
      schedule, activity tolerance, and length of stay allows. Intervention will consist of 1-hour
      sessions occurring according to the availability of the participant at the rate of no more
      than 2 sessions in a 24 hour period.

      Investigators hope to investigate these questions:

        1. Can the movement of healthy individuals be characterized with error augmented visual
           feedback and veridical visual feedback?

        2. Will error augmented visual feedback or veridical visual feedback result in greater
           movement ability improvement?

           Investigators hypothesize that in the Chronic Arm, those what trained with
           error-augmented visual feedback will have improved movement ability compared to those
           who trained with veridical visual feedback.

        3. Is treatment with the looking glass and leap system feasible with an inpatient
           population?

      Investigators hypothesize that this treatment will be feasible for an inpatient population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Fugl Meyer Upper Extremity Score: Pre to Post/Discharge - Chronic and Acute Arms
time frame: 1-3 weeks for acute arm; 9 weeks for chronic arm
description: Change in Fugl Meyer score from pre-evaluation to post -evaluation
measure: Fugl Meyer Upper Extremity Score: Pre to Follow-up
time frame: 4.5 months
description: Change in Fugl Meyer score from pre-evaluation to follow-up-evaluation - Chronic Arm
measure: Amount of use
time frame: 1-3 weeks, on average
description: Time spent in treatment - Acute Arm
measure: Action Research Arm Test Score: Pre to Post
time frame: 1-3 weeks for acute arm; 9 weeks for chronic arm
description: Change in Action Research Arm Test score from pre-evaluation to post -evaluation: Chronic and Acute Arms
measure: Action Research Arm Test Score: Pre to Follow-Up
time frame: 4.5 months
description: Change in Action Research Arm Test score from pre-evaluation to Follow-up -evaluation: Chronic Arm
arm group label: Healthy
arm group type: Active Comparator
description: Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system
arm group label: Chronic Veridical Visual Feedback
arm group type: Experimental
description: Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
arm group label: Chronic Augmented Visual Feedback
arm group type: Experimental
description: Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.
arm group label: Acute Veridical Visual Feedback
arm group type: Experimental
description: Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
arm group label: Acute Augmented Visual Feedback
arm group type: Experimental
description: Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.
intervention type: Other
intervention name: Veridical Visual Feedback
description: Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
arm group label: Acute Veridical Visual Feedback
arm group label: Chronic Veridical Visual Feedback
other name: Reaching
intervention type: Other
intervention name: Augmented Visual Feedback
description: Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.
arm group label: Acute Augmented Visual Feedback
arm group label: Chronic Augmented Visual Feedback
other name: Reaching
other name: Error Augmentation
intervention type: Other
intervention name: Healthy Comparative Reaching Task
description: Reaching while sitting at the Looking Glass system. This will occur over the course of 1 hour.
arm group label: Healthy
other name: Healthy Reaching
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Patton
role: Principal Investigator
affiliation: Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)
last name: Courtney Celian, MSOT
phone: 312-238-1560
email: ccelian@sralab.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: James Patton
investigator title: Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab
mesh term: Stroke
sharing ipd: Undecided