<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/NCT03813342</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00097573</org_study_id>
    <secondary_id>2R37NS090610</secondary_id>
    <nct_id>NCT03813342</nct_id>
  </id_info>
  <brief_title>Retraining the Walking Pattern After Stroke</brief_title>
  <official_title>Retraining the Walking Pattern After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hugo W. Moser Research Institute at Kennedy Krieger, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Hugo W. Moser Research Institute at Kennedy Krieger, Inc.</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 purpose of the study is to determine the effects of pairing gait training with different&#xD;
      forms of visual feedback about leg movements in individual post-stroke to modify/normalize&#xD;
      their gait pattern over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke often results in functional gait deficits and abnormal gait patterns. Typically,&#xD;
      several features of gait are altered (e.g. knee joint movement decreases and step lengths are&#xD;
      asymmetric). Data show that walking patterns after neurologic injury can be changed through&#xD;
      gait training, but traditional rehabilitation approaches typically focus on changing one&#xD;
      feature of gait at a time. However, the investigators have recently shown that in a single&#xD;
      session individuals post-stroke are able to learn to change multiple components of this&#xD;
      impaired gait pattern at the same time.&#xD;
&#xD;
      To further leverage this ability to learn multiple things at once, the investigators have&#xD;
      also studied how different forms of visual feedback about leg movements may best facilitate&#xD;
      individuals to make meaningful changes to multiple features of the gait pattern.&#xD;
      Specifically, they have studied two forms of visual feedback - 1) multidimensional, with&#xD;
      multiple streams of information about leg movements, and 2) one-dimensional, which&#xD;
      distills/summarizes multiple pieces of information about the gait pattern into a single&#xD;
      source of feedback. They have shown that the one-dimensional summary feedback is more&#xD;
      effective to help people learn a new gait pattern that requires changing multiple features of&#xD;
      how they are walking. This work has focused on single training sessions in neurologically&#xD;
      intact individuals, but the authors would like to study the effects of longer-term training&#xD;
      with these different forms of feedback. Therefore, the purpose of this study is to gather&#xD;
      preliminary data to inform the design of a clinical trial of gait training to treat walking&#xD;
      deficits post-stroke. The investigators will gather data to determine whether training with&#xD;
      different forms of visual feedback about leg movements are effective at improving gait&#xD;
      patterns post-stroke - and which form of feedback may be more effective.&#xD;
&#xD;
      The investigators will study adults with cerebral damage due to stroke. Subjects with&#xD;
      hemiparesis will undergo training 3 times a week for a total of 12 training session. These 12&#xD;
      sessions will be broken into 2 blocks of 6 sessions, with at least a 2 week break in between.&#xD;
      In each block, training will occur with one form of visual (multi- or one-dimensional).&#xD;
      Participants will complete training with both forms of feedback, the order of feedback forms&#xD;
      will be randomly assigned. These studies will provide important new information about gait&#xD;
      training with visual feedback in individuals post-stroke. This study is critical for&#xD;
      developing procedural reliability processes, calculating effect sizes, and determining other&#xD;
      salient clinical variables in preparation for a randomized clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">April 14, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 14, 2024</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>
    <intervention_model_description>treadmill with multi-dimensional and one-dimensional feedback</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1. Change in hip and knee joint movements while walking</measure>
    <time_frame>Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.</time_frame>
    <description>How closely the hip and knee movements in participants post-stroke match those of a healthy gait patter. To collect this measure, subjects will wear special markers on their feet and body to record how their legs are moving while they walk on the treadmill.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1. Change in walking speed</measure>
    <time_frame>Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.</time_frame>
    <description>Subjects will complete clinical tests of walking speed by walking overground at two paces - their normal comfortable pace and as fast as safely possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2. Change in subjective assessment of balance confidence</measure>
    <time_frame>Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.</time_frame>
    <description>Subjects will complete the 16-item Activities-Specific Balance Confidence Scale. This is a self-report measure in which they rate their confidence that they would not lose their balance while performing specific daily activities. Scores can range from 0 - 100, with 0 indicating the respondent has no confidence in their balance and 100 indicating that they are full confident that they can perform all items without a loss of balance. As such, higher values represent a better outcome. There are no sub-scales for this measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Stroke</condition>
  <condition>Hemiparesis</condition>
  <arm_group>
    <arm_group_label>Multichannel Visual Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 4 channels of visual information, each of which represents a joint angle (right and left hips, right and left knees).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Channel Visual Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 1 channel of visual information that encompasses information from 4 lower limb joint angles (right and left hips, right and left knees).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gait training with visual feedback of joint kinematics</intervention_name>
    <description>Gait training will be accomplished using a Woodway treadmill. The visual feedback will contain information about the real-time lower-limb joint angles. We will instruct participants to use the feedback to reach a target walking pattern.</description>
    <arm_group_label>Multichannel Visual Feedback</arm_group_label>
    <arm_group_label>Single Channel Visual Feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stroke or hemiparesis (&gt;6 months post stroke)&#xD;
&#xD;
          -  able to walk but has a residual gait deficit (including those who walk with a cane or&#xD;
             walker)&#xD;
&#xD;
          -  Able to walk for 5 minutes at their self-paced speed&#xD;
&#xD;
          -  Adults age 20-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cerebellar signs (e.g.ataxic hemiparesis)&#xD;
&#xD;
          -  Any neurologic condition other than stroke&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Peripheral artery disease with claudication&#xD;
&#xD;
          -  Pulmonary or renal failure&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Uncontrolled hypertension (&gt;190/110 mmHg)&#xD;
&#xD;
          -  MoCA (Montreal Cognitive Assessment Test for Dementia) &lt; 23&#xD;
&#xD;
          -  Severe aphasia&#xD;
&#xD;
          -  Orthopedic or pain conditions that limit walking&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy J Bastian, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kennedy Krieger Institute and Johns Hopkins School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anthony Gonzalez, BS</last_name>
    <phone>4439232716</phone>
    <email>gonzalezan@kennedykrieger.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Motion Analysis Lab in the Kennedy Krieger Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony J Gonzalez, BS</last_name>
      <phone>443-923-2716</phone>
      <email>gonzalezan@kennedykrieger.org</email>
    </contact>
    <investigator>
      <last_name>Amy J Bastian, PhD, PT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hugo W. Moser Research Institute at Kennedy Krieger, Inc.</investigator_affiliation>
    <investigator_full_name>Amy J. Bastian, Ph.D.</investigator_full_name>
    <investigator_title>Professor of Neuroscience</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>gait training</keyword>
  <keyword>visual feedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03813342
org study id: IRB00097573
secondary id: 2R37NS090610
nct id: NCT03813342
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine the effects of pairing gait training with different
      forms of visual feedback about leg movements in individual post-stroke to modify/normalize
      their gait pattern over time.
Stroke often results in functional gait deficits and abnormal gait patterns. Typically,
      several features of gait are altered (e.g. knee joint movement decreases and step lengths are
      asymmetric). Data show that walking patterns after neurologic injury can be changed through
      gait training, but traditional rehabilitation approaches typically focus on changing one
      feature of gait at a time. However, the investigators have recently shown that in a single
      session individuals post-stroke are able to learn to change multiple components of this
      impaired gait pattern at the same time.

      To further leverage this ability to learn multiple things at once, the investigators have
      also studied how different forms of visual feedback about leg movements may best facilitate
      individuals to make meaningful changes to multiple features of the gait pattern.
      Specifically, they have studied two forms of visual feedback - 1) multidimensional, with
      multiple streams of information about leg movements, and 2) one-dimensional, which
      distills/summarizes multiple pieces of information about the gait pattern into a single
      source of feedback. They have shown that the one-dimensional summary feedback is more
      effective to help people learn a new gait pattern that requires changing multiple features of
      how they are walking. This work has focused on single training sessions in neurologically
      intact individuals, but the authors would like to study the effects of longer-term training
      with these different forms of feedback. Therefore, the purpose of this study is to gather
      preliminary data to inform the design of a clinical trial of gait training to treat walking
      deficits post-stroke. The investigators will gather data to determine whether training with
      different forms of visual feedback about leg movements are effective at improving gait
      patterns post-stroke - and which form of feedback may be more effective.

      The investigators will study adults with cerebral damage due to stroke. Subjects with
      hemiparesis will undergo training 3 times a week for a total of 12 training session. These 12
      sessions will be broken into 2 blocks of 6 sessions, with at least a 2 week break in between.
      In each block, training will occur with one form of visual (multi- or one-dimensional).
      Participants will complete training with both forms of feedback, the order of feedback forms
      will be randomly assigned. These studies will provide important new information about gait
      training with visual feedback in individuals post-stroke. This study is critical for
      developing procedural reliability processes, calculating effect sizes, and determining other
      salient clinical variables in preparation for a randomized clinical trial.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: treadmill with multi-dimensional and one-dimensional feedback
primary purpose: Treatment
masking: None (Open Label)
measure: 1. Change in hip and knee joint movements while walking
time frame: Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.
description: How closely the hip and knee movements in participants post-stroke match those of a healthy gait patter. To collect this measure, subjects will wear special markers on their feet and body to record how their legs are moving while they walk on the treadmill.
measure: 1. Change in walking speed
time frame: Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.
description: Subjects will complete clinical tests of walking speed by walking overground at two paces - their normal comfortable pace and as fast as safely possible.
measure: 2. Change in subjective assessment of balance confidence
time frame: Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.
description: Subjects will complete the 16-item Activities-Specific Balance Confidence Scale. This is a self-report measure in which they rate their confidence that they would not lose their balance while performing specific daily activities. Scores can range from 0 - 100, with 0 indicating the respondent has no confidence in their balance and 100 indicating that they are full confident that they can perform all items without a loss of balance. As such, higher values represent a better outcome. There are no sub-scales for this measure.
arm group label: Multichannel Visual Feedback
arm group type: Experimental
description: Gait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 4 channels of visual information, each of which represents a joint angle (right and left hips, right and left knees).
arm group label: Single Channel Visual Feedback
arm group type: Experimental
description: Gait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 1 channel of visual information that encompasses information from 4 lower limb joint angles (right and left hips, right and left knees).
intervention type: Behavioral
intervention name: Gait training with visual feedback of joint kinematics
description: Gait training will be accomplished using a Woodway treadmill. The visual feedback will contain information about the real-time lower-limb joint angles. We will instruct participants to use the feedback to reach a target walking pattern.
arm group label: Multichannel Visual Feedback
arm group label: Single Channel Visual Feedback
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Amy J Bastian, PhD, PT
role: Principal Investigator
affiliation: Kennedy Krieger Institute and Johns Hopkins School of Medicine
last name: Anthony Gonzalez, BS
phone: 4439232716
email: gonzalezan@kennedykrieger.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
investigator full name: Amy J. Bastian, Ph.D.
investigator title: Professor of Neuroscience
mesh term: Stroke
mesh term: Paresis