<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/NCT04411303</url>
  </required_header>
  <id_info>
    <org_study_id>HS-20-01887</org_study_id>
    <nct_id>NCT04411303</nct_id>
  </id_info>
  <brief_title>A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation</brief_title>
  <official_title>A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</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 project is to determine the feasibility and optimal parameters of a novel,&#xD;
      comprehensive approach to gait training in individuals with chronic stroke. The comprehensive&#xD;
      approach includes biofeedback-based gait training and aerobic exercise intensity-based gait&#xD;
      training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this project is to determine the feasibility and optimal parameters of a novel,&#xD;
      comprehensive approach to gait training in individuals with chronic stroke. Current&#xD;
      post-stroke gait training follows two distinct approaches that target different domains of&#xD;
      gait dysfunction (as defined by the International Classification of Functioning, Health, and&#xD;
      Disability). Biofeedback-based gait training is typically employed to treat walking pattern&#xD;
      impairments (e.g., kinematic deviations relative to able-bodied controls); whereas, aerobic&#xD;
      exercise intensity-based gait training is the current gold-standard to treat walking activity&#xD;
      limitations (e.g., slow walking speeds). Here, the investigators propose to test the impact&#xD;
      of combining these approaches into a single intervention to work toward the development of a&#xD;
      more effective, comprehensive approach to gait rehabilitation for persons post-stroke. The&#xD;
      central hypothesis is that individuals with chronic stroke have the capacity to use&#xD;
      biofeedback to reduce kinematic gait deviations while walking at a range of recommended&#xD;
      aerobic exercise intensity zones. Aim 1 will identify the gait biofeedback variable that&#xD;
      elicits the largest reduction in interlimb asymmetry in persons post-stroke. Aim 2 will&#xD;
      determine the capacity for persons post-stroke to make biofeedback-driven reductions in their&#xD;
      interlimb asymmetry while walking at three different aerobic exercise intensities.&#xD;
      Participants with chronic stroke in Aim 1 will each complete three experimental sessions and&#xD;
      participants in Aim 2 will complete 1 experimental session. Biomechanical analyses and&#xD;
      physiologic assessments will be used across both aims to test our working hypotheses. The&#xD;
      investigators expect to show that biofeedback of paretic propulsion leads to the greatest&#xD;
      reduction in interlimb asymmetry and that participants have the capacity to make&#xD;
      biofeedback-driven interlimb asymmetry reductions while walking at all three aerobic&#xD;
      intensities, but the magnitude of reduction will be the largest at a moderate aerobic walking&#xD;
      intensity. The proposed work is innovative because it will be the first to test the relative&#xD;
      effects of different gait biofeedback variables on whole lower extremity kinematics in&#xD;
      persons post-stroke and test a novel combination of two well-established gait training&#xD;
      approaches (biofeedback- and intensity-based) for neurologic patient populations. This is a&#xD;
      critical next step in moving the post-stroke gait rehabilitation field forward. If&#xD;
      successful, this line of work stands to significantly improve the current standard of care in&#xD;
      gait rehabilitation post-stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 6, 2021</start_date>
  <completion_date type="Anticipated">December 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 14, 2023</primary_completion_date>
  <phase>Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interlimb Asymmetry - change in performance</measure>
    <time_frame>Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the biofeedback training; participants will complete 3 testing sessions over approximately 2 months</time_frame>
    <description>characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify change in performance with biofeedback</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interlimb asymmetry - immediate retention</measure>
    <time_frame>Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months</time_frame>
    <description>characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify retention of a newly learned walking pattern</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>CVA (Cerebrovascular Accident)</condition>
  <arm_group>
    <arm_group_label>Reducing interlimb asymmetry with biofeedback post-stroke</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will use a randomized crossover design to determine the performance and retention effects following single-day training sessions with biofeedback of three different gait variables (i.e., step length, propulsive force, and interlimb asymmetry) in 25 individuals with chronic stroke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evaluating capacity for biofeedback use at varied intensities</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will use a within-session randomized crossover design to test the capacity of persons post-stroke (second cohort; n=25) to reduce their interlimb asymmetry using the biofeedback variable found to be the most effective for the group in Aim 1 while walking in three aerobic intensity zones: low, moderate, and vigorous (30-40%, 50-60%, and 70-80% of heart rate reserve, respectively).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Step length biofeedback</intervention_name>
    <description>Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.</description>
    <arm_group_label>Reducing interlimb asymmetry with biofeedback post-stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Propulsive force biofeedback</intervention_name>
    <description>Participants will be provided with real-time visual feedback of anterior-posterior ground reaction forces of the paretic limb during stance phase on a screen in front of a treadmill.</description>
    <arm_group_label>Reducing interlimb asymmetry with biofeedback post-stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interlimb asymmetry biofeedback</intervention_name>
    <description>Participants will be provided with visual feedback of stride-by-stride values of their interlimb asymmetry on a screen in front of a treadmill.</description>
    <arm_group_label>Reducing interlimb asymmetry with biofeedback post-stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic intensity-based walking</intervention_name>
    <description>Participants will walk at three different aerobic intensities. Aerobic intensity will be set based on target heart rate zones calculated with the Karvonen Formula. For low intensity, participants will walk at 30-40% intensity. In moderate intensity conditions, participants will walk at a 50-60% intensity level. In vigorous intensity conditions, participants will walk at an 70-80% intensity level. Aerobic intensity will be manipulated by changing walking speed.</description>
    <arm_group_label>Evaluating capacity for biofeedback use at varied intensities</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;6 months post stroke, affecting 1 hemisphere of the brain&#xD;
&#xD;
          -  Independently ambulatory (including use assistive devices)&#xD;
&#xD;
          -  Able to walk for 5 minutes without stopping&#xD;
&#xD;
          -  Demonstrates readiness for exercise based on responses to the PAR-Q+&#xD;
&#xD;
          -  Participants enrolled in Aim 2 will require medical clearance from physician to&#xD;
             participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Damage to the pons or cerebellum on MRI or signs of cerebellar involvement&#xD;
&#xD;
          -  Damage to the basal ganglia or extrapyramidal symptoms&#xD;
&#xD;
          -  Uncontrolled hypertension (&gt;160/100mmHg)&#xD;
&#xD;
          -  Montreal Cognitive Assessment score &lt; 25&#xD;
&#xD;
          -  Orthopedic or pain conditions&#xD;
&#xD;
               -  Note*: Pregnant women are excluded from this study to avoid any potential harm to&#xD;
                  the fetus from the harness used during treadmill walking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristan Leech, PT, DPT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kristan Leech, PT, DPT, PhD</last_name>
    <phone>(323) 442-1583</phone>
    <email>kleech@pt.usc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Kettlety, MS</last_name>
    <phone>(323) 442-1196</phone>
    <email>kettlety@usc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristan Leech, Phd</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>July 8, 2023</last_update_submitted>
  <last_update_submitted_qc>July 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Kristan Leech</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>walking</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>aerobic exercise</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>Yes</sharing_ipd>
    <ipd_description>All de-identified data from our research that underlie results in a publication will be made available.</ipd_description>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available 6 months after publication.</ipd_time_frame>
  </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/NCT04411303
org study id: HS-20-01887
nct id: NCT04411303
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this project is to determine the feasibility and optimal parameters of a novel,
      comprehensive approach to gait training in individuals with chronic stroke. The comprehensive
      approach includes biofeedback-based gait training and aerobic exercise intensity-based gait
      training.
The goal of this project is to determine the feasibility and optimal parameters of a novel,
      comprehensive approach to gait training in individuals with chronic stroke. Current
      post-stroke gait training follows two distinct approaches that target different domains of
      gait dysfunction (as defined by the International Classification of Functioning, Health, and
      Disability). Biofeedback-based gait training is typically employed to treat walking pattern
      impairments (e.g., kinematic deviations relative to able-bodied controls); whereas, aerobic
      exercise intensity-based gait training is the current gold-standard to treat walking activity
      limitations (e.g., slow walking speeds). Here, the investigators propose to test the impact
      of combining these approaches into a single intervention to work toward the development of a
      more effective, comprehensive approach to gait rehabilitation for persons post-stroke. The
      central hypothesis is that individuals with chronic stroke have the capacity to use
      biofeedback to reduce kinematic gait deviations while walking at a range of recommended
      aerobic exercise intensity zones. Aim 1 will identify the gait biofeedback variable that
      elicits the largest reduction in interlimb asymmetry in persons post-stroke. Aim 2 will
      determine the capacity for persons post-stroke to make biofeedback-driven reductions in their
      interlimb asymmetry while walking at three different aerobic exercise intensities.
      Participants with chronic stroke in Aim 1 will each complete three experimental sessions and
      participants in Aim 2 will complete 1 experimental session. Biomechanical analyses and
      physiologic assessments will be used across both aims to test our working hypotheses. The
      investigators expect to show that biofeedback of paretic propulsion leads to the greatest
      reduction in interlimb asymmetry and that participants have the capacity to make
      biofeedback-driven interlimb asymmetry reductions while walking at all three aerobic
      intensities, but the magnitude of reduction will be the largest at a moderate aerobic walking
      intensity. The proposed work is innovative because it will be the first to test the relative
      effects of different gait biofeedback variables on whole lower extremity kinematics in
      persons post-stroke and test a novel combination of two well-established gait training
      approaches (biofeedback- and intensity-based) for neurologic patient populations. This is a
      critical next step in moving the post-stroke gait rehabilitation field forward. If
      successful, this line of work stands to significantly improve the current standard of care in
      gait rehabilitation post-stroke.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Interlimb Asymmetry - change in performance
time frame: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the biofeedback training; participants will complete 3 testing sessions over approximately 2 months
description: characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify change in performance with biofeedback
measure: Interlimb asymmetry - immediate retention
time frame: Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months
description: characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify retention of a newly learned walking pattern
arm group label: Reducing interlimb asymmetry with biofeedback post-stroke
arm group type: Experimental
description: We will use a randomized crossover design to determine the performance and retention effects following single-day training sessions with biofeedback of three different gait variables (i.e., step length, propulsive force, and interlimb asymmetry) in 25 individuals with chronic stroke.
arm group label: Evaluating capacity for biofeedback use at varied intensities
arm group type: Experimental
description: We will use a within-session randomized crossover design to test the capacity of persons post-stroke (second cohort; n=25) to reduce their interlimb asymmetry using the biofeedback variable found to be the most effective for the group in Aim 1 while walking in three aerobic intensity zones: low, moderate, and vigorous (30-40%, 50-60%, and 70-80% of heart rate reserve, respectively).
intervention type: Behavioral
intervention name: Step length biofeedback
description: Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.
arm group label: Reducing interlimb asymmetry with biofeedback post-stroke
intervention type: Behavioral
intervention name: Propulsive force biofeedback
description: Participants will be provided with real-time visual feedback of anterior-posterior ground reaction forces of the paretic limb during stance phase on a screen in front of a treadmill.
arm group label: Reducing interlimb asymmetry with biofeedback post-stroke
intervention type: Behavioral
intervention name: Interlimb asymmetry biofeedback
description: Participants will be provided with visual feedback of stride-by-stride values of their interlimb asymmetry on a screen in front of a treadmill.
arm group label: Reducing interlimb asymmetry with biofeedback post-stroke
intervention type: Behavioral
intervention name: Aerobic intensity-based walking
description: Participants will walk at three different aerobic intensities. Aerobic intensity will be set based on target heart rate zones calculated with the Karvonen Formula. For low intensity, participants will walk at 30-40% intensity. In moderate intensity conditions, participants will walk at a 50-60% intensity level. In vigorous intensity conditions, participants will walk at an 70-80% intensity level. Aerobic intensity will be manipulated by changing walking speed.
arm group label: Evaluating capacity for biofeedback use at varied intensities
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kristan Leech, PT, DPT, PhD
role: Principal Investigator
affiliation: University of Southern California
last name: Kristan Leech, PT, DPT, PhD
phone: (323) 442-1583
email: kleech@pt.usc.edu
last name: Sarah Kettlety, MS
phone: (323) 442-1196
email: kettlety@usc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Kristan Leech
investigator title: Assistant Professor
mesh term: Stroke
sharing ipd: Yes
ipd description: All de-identified data from our research that underlie results in a publication will be made available.
ipd info type: Analytic Code
ipd time frame: Data will be available 6 months after publication.