<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/NCT03787693</url>
  </required_header>
  <id_info>
    <org_study_id>291-14-EP</org_study_id>
    <nct_id>NCT03787693</nct_id>
  </id_info>
  <brief_title>Virtual Reality Augmented Gait Adaptation in Stroke Survivors</brief_title>
  <official_title>Virtual Reality Augmented Gait Adaptation in Stroke Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</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 major problem in stroke survivors that is being addressed in this research project is&#xD;
      walking asymmetry, i.e., difference between the legs during walking (e.g. steps on the more&#xD;
      affected side are longer than the other). A potential solution to this problem is using new&#xD;
      technology like virtual reality during walking training to make stroke survivors have a&#xD;
      better sense of their asymmetry. A second problem that we aim to address in this study is&#xD;
      whether asymmetry is accurately felt by the stroke survivors and how we can address it. Our&#xD;
      ongoing work on the effects of virtual reality on learning new walking tasks in stroke&#xD;
      survivors indicates that virtual reality maybe particularly important for those with walking&#xD;
      asymmetry. In this study, we plan to recruit stroke survivors who have such asymmetries&#xD;
      during walking and have them learn a new walking task in virtual reality. We will also test&#xD;
      the stroke survivors to determine if there is a relationship between how well they learn the&#xD;
      new task with their ability to feel asymmetry accurately.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke survivors show a deterioration in bilateral coordination during gait that impacts&#xD;
      functional mobility and quality of life. Such deterioration includes spatial (e.g. step&#xD;
      length) and temporal (e.g. step time) inter-limb asymmetries during walking (gait asymmetry).&#xD;
      While restoration of gait symmetry through adaptive exercise as in split-belt training is an&#xD;
      answer, it is compounded by deficits of perception that is common in stroke survivors. One&#xD;
      solution to this problem is the use of augmented visual feedback such as virtual reality&#xD;
      (VR). Such augmented visual inputs during training can help remove sensory conflicts that&#xD;
      commonly exist during gait rehabilitation (e.g. static visual input versus motion perception&#xD;
      through proprioceptive input during treadmill walking). The PI's ongoing research&#xD;
      investigating the effects of VR on gait adaptation in stroke survivors indicates that the&#xD;
      impact of VR is dependent on the subject's baseline gait asymmetry such that the effect of VR&#xD;
      is potentially higher in those who have large baseline asymmetries. Therefore, in the current&#xD;
      proposal, to determine if this hypothesis is correct, chronic stroke survivors who are above&#xD;
      and below a specific asymmetry threshold will be recruited and assessed for the effect of VR&#xD;
      on a split-belt treadmill paradigm. In the second aim, the effect of VR on the transfer of&#xD;
      split-belt adaptation to a preferred walking trial will be assessed. Since stroke survivors&#xD;
      also suffer from major perceptual deficits related to symmetry, in the third aim, the effect&#xD;
      of VR on gait adaptation on four groups of stroke survivors will be analyzed those with&#xD;
      deficits only in perceiving visual asymmetry, only gait asymmetry, both deficits or neither.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Chronic stroke survivors will be screened and assigned to either a Symmetric or Asymmetric group based on inter-limb step length and/or step time asymmetry at baseline. Each subject will be randomly assigned to perform a split-belt adaptation protocol in either a VR or a Non-VR environment.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The PI and the subject will not be aware of the group assignment of each subject.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Step-length Symmetry Index</measure>
    <time_frame>1 day</time_frame>
    <description>Difference between the length of a step taken by one limb from the other limb</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Step-time Symmetry Index</measure>
    <time_frame>1 day</time_frame>
    <description>Difference between the time of a step taken by one limb from the other limb</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Stroke Symmetric Non-VR</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this control arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a non-virtual reality environment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stroke Symmetric VR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this experimental arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stroke Asymmetric Non-VR</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this control arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a non-virtual reality environment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stroke Asymmetric VR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this experimental arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VR - Virtual Reality</intervention_name>
    <description>Subjects in the experimental group will perform the split-belt task in a VR environment</description>
    <arm_group_label>Stroke Asymmetric VR</arm_group_label>
    <arm_group_label>Stroke Symmetric VR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults &gt; 21 years&#xD;
&#xD;
          -  diagnosed with supratentorial ischemic or hemorrhagic stroke&#xD;
&#xD;
          -  single, unilateral stroke&#xD;
&#xD;
          -  stroke incident &gt; 3 months duration.&#xD;
&#xD;
          -  ability to stand unsupported without an assistive device&#xD;
&#xD;
          -  walk 10m without therapist assistance,&#xD;
&#xD;
          -  ability to follow instructions (Folstein Mini-Mental exam score ≥ 24)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recurrent stroke&#xD;
&#xD;
          -  hip fracture&#xD;
&#xD;
          -  myocardial infarction&#xD;
&#xD;
          -  &lt; 20/40 corrected vision&#xD;
&#xD;
          -  any condition that can affect walking ability to complete the experiment successfully&#xD;
             (e.g. neglect, Parkinson's disease, vestibulopathy, peripheral nerve pathology).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mukul Mukherjee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mukul Mukherjee, PhD</last_name>
    <phone>402-554-3351</phone>
    <email>mmukherjee@unomaha.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Biomechanics Research Building</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68182</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Mukul Mukherjee</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>hemiparesis</keyword>
  <keyword>gait</keyword>
  <keyword>perception</keyword>
  <keyword>sensory</keyword>
  <keyword>vision</keyword>
  <keyword>coordination</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/NCT03787693
org study id: 291-14-EP
nct id: NCT03787693
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The major problem in stroke survivors that is being addressed in this research project is
      walking asymmetry, i.e., difference between the legs during walking (e.g. steps on the more
      affected side are longer than the other). A potential solution to this problem is using new
      technology like virtual reality during walking training to make stroke survivors have a
      better sense of their asymmetry. A second problem that we aim to address in this study is
      whether asymmetry is accurately felt by the stroke survivors and how we can address it. Our
      ongoing work on the effects of virtual reality on learning new walking tasks in stroke
      survivors indicates that virtual reality maybe particularly important for those with walking
      asymmetry. In this study, we plan to recruit stroke survivors who have such asymmetries
      during walking and have them learn a new walking task in virtual reality. We will also test
      the stroke survivors to determine if there is a relationship between how well they learn the
      new task with their ability to feel asymmetry accurately.
Stroke survivors show a deterioration in bilateral coordination during gait that impacts
      functional mobility and quality of life. Such deterioration includes spatial (e.g. step
      length) and temporal (e.g. step time) inter-limb asymmetries during walking (gait asymmetry).
      While restoration of gait symmetry through adaptive exercise as in split-belt training is an
      answer, it is compounded by deficits of perception that is common in stroke survivors. One
      solution to this problem is the use of augmented visual feedback such as virtual reality
      (VR). Such augmented visual inputs during training can help remove sensory conflicts that
      commonly exist during gait rehabilitation (e.g. static visual input versus motion perception
      through proprioceptive input during treadmill walking). The PI's ongoing research
      investigating the effects of VR on gait adaptation in stroke survivors indicates that the
      impact of VR is dependent on the subject's baseline gait asymmetry such that the effect of VR
      is potentially higher in those who have large baseline asymmetries. Therefore, in the current
      proposal, to determine if this hypothesis is correct, chronic stroke survivors who are above
      and below a specific asymmetry threshold will be recruited and assessed for the effect of VR
      on a split-belt treadmill paradigm. In the second aim, the effect of VR on the transfer of
      split-belt adaptation to a preferred walking trial will be assessed. Since stroke survivors
      also suffer from major perceptual deficits related to symmetry, in the third aim, the effect
      of VR on gait adaptation on four groups of stroke survivors will be analyzed those with
      deficits only in perceiving visual asymmetry, only gait asymmetry, both deficits or neither.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Chronic stroke survivors will be screened and assigned to either a Symmetric or Asymmetric group based on inter-limb step length and/or step time asymmetry at baseline. Each subject will be randomly assigned to perform a split-belt adaptation protocol in either a VR or a Non-VR environment.
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: The PI and the subject will not be aware of the group assignment of each subject.
measure: Step-length Symmetry Index
time frame: 1 day
description: Difference between the length of a step taken by one limb from the other limb
measure: Step-time Symmetry Index
time frame: 1 day
description: Difference between the time of a step taken by one limb from the other limb
arm group label: Stroke Symmetric Non-VR
arm group type: No Intervention
description: In this control arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a non-virtual reality environment.
arm group label: Stroke Symmetric VR
arm group type: Experimental
description: In this experimental arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.
arm group label: Stroke Asymmetric Non-VR
arm group type: No Intervention
description: In this control arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a non-virtual reality environment.
arm group label: Stroke Asymmetric VR
arm group type: Experimental
description: In this experimental arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.
intervention type: Behavioral
intervention name: VR - Virtual Reality
description: Subjects in the experimental group will perform the split-belt task in a VR environment
arm group label: Stroke Asymmetric VR
arm group label: Stroke Symmetric VR
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mukul Mukherjee, PhD
role: Principal Investigator
affiliation: University of Nebraska
last name: Mukul Mukherjee, PhD
phone: 402-554-3351
email: mmukherjee@unomaha.edu
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Mukul Mukherjee
investigator title: Associate Professor
mesh term: Stroke