<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/NCT02990650</url>
  </required_header>
  <id_info>
    <org_study_id>STU00001977</org_study_id>
    <nct_id>NCT02990650</nct_id>
  </id_info>
  <brief_title>Outcomes Associated With Progressive Balance And Gait Training Using The KineAssist® Robot</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using a randomized controlled research design, compare walking outcomes resulting from gait&#xD;
      and balance training with standard physical therapist interaction versus training with the&#xD;
      addition of a KineAssist® robotic system that provides for safety and freedom of movement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies have investigated the use of balance and gait training and have demonstrated&#xD;
      significant improvements in walking speed with trained stroke survivors. The inherent risks&#xD;
      associated with balance and gait training requires the therapist to be vigilant with&#xD;
      providing safety and support during challenging tasks. As a result, consumers are not&#xD;
      challenged to their furthest limits and therapists put an inordinate amount of physical&#xD;
      effort into safety control. KineAssist® Design, LLC in collaboration with Rehabilitation&#xD;
      Institute of Chicago, developed the KineAssist® Balance and Gait Training System&#xD;
      (KineAssist®). The KineAssist® is a novel device that allows full freedom of motion for the&#xD;
      trunk and pelvis during gait and balance tasks, with additional postural control to enhance&#xD;
      balance stability. These functions are available while the device follows the individual&#xD;
      overground with minimal interference. The availability of postural control during complex and&#xD;
      omnidirectional movement tasks allows the clinician to guarantee consumer safety and body&#xD;
      weight support while at the same time provide graded task challenges to the fullest limits of&#xD;
      the consumers capabilities. This KineAssist® is revolutionary in that it is the first device&#xD;
      that is fully interactive and responsive to the movements and intentions of both the consumer&#xD;
      and the therapist during overground challenging balance and gait activities.&#xD;
&#xD;
      Accordingly, the long-term objective of this research is to test the efficacy of robotically&#xD;
      enhanced, progressive gait and balance training for improving walking outcomes post-stroke.&#xD;
      The following two aims are designed to test whether the KineAssist® provides a more&#xD;
      challenging training environment than is typical with physical therapy, and then compares&#xD;
      walking outcomes as a result of long-term (6 weeks) training.&#xD;
&#xD;
      Aim: Using a randomized controlled research design, compare walking outcomes resulting from&#xD;
      gait and balance training with standard physical therapist interaction versus training with&#xD;
      the addition of a KineAssist®t.&#xD;
&#xD;
      Overall, these studies are an important advance for the development of effective clinical&#xD;
      interventions for individuals with impaired locomotor ability post-stroke. This study will&#xD;
      provide critical information on physiological effects and clinical outcomes and provide&#xD;
      important evidence for the use of this new class of robotic technology that accommodates both&#xD;
      the clinician and the consumer in stroke rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2008</start_date>
  <primary_completion_date type="Actual">September 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean time of 10 meter walk test at baseline</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean time of 10 meter walk test at 3 weeks post baseline</measure>
    <time_frame>3 weeks post baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean time of 10 meter walk test at 6 weeks at end of training</measure>
    <time_frame>6 weeks post baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean time of 10 meter walk test at 6 months post training</measure>
    <time_frame>6 months post end of training</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean time of 6 minute walk test at baseline</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean time of 6 minute walk test at 3 weeks post baseline</measure>
    <time_frame>3 weeks post baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean time of 6 minute walk test at 6 weeks post baseline (end of training)</measure>
    <time_frame>6 weeks post baseline (end of training)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean time of 6 minute walk test at 6 months post training</measure>
    <time_frame>6 months post end of training (7.5 months post baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Berg Balance Scale score at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Berg Balance Scale score at 3 weeks post baseline</measure>
    <time_frame>3 weeks post baseline</time_frame>
    <description>The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Berg Balance Scale score at 6 weeks post baseline (end of training)</measure>
    <time_frame>6 weeks post baseline</time_frame>
    <description>The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Berg Balance Scale score at 6 months post end of training</measure>
    <time_frame>6 months post end of training (7.5 months post baseline)</time_frame>
    <description>The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Cerebrovascular Accident</condition>
  <arm_group>
    <arm_group_label>Standard physical therapist</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A combination of nine balance training tasks where the physical therapist provides guarding against loss of balance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard robotic guarding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A combination of nine balance training tasks where the robotic system provides guarding against loss of balance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>challenge based robotic guarding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A combination of nine balance training tasks where the robotic system provides guarding against loss of balance while the participant works at a level greater than their current balance capability</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Balance Task Training with therapist guarding support</intervention_name>
    <description>Nine balance tasks:&#xD;
long forward step&#xD;
forward reach&#xD;
push forward&#xD;
push backward&#xD;
step over hurdle&#xD;
step up on foam surface&#xD;
step up on solid surface&#xD;
sit-to-stand&#xD;
step onto slippery surface The therapist will provide guarding support</description>
    <arm_group_label>Standard physical therapist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Balance task training with robotic guarding support</intervention_name>
    <description>Nine balance tasks:&#xD;
long forward step&#xD;
forward reach&#xD;
push forward&#xD;
push backward&#xD;
step over hurdle&#xD;
step up on foam surface&#xD;
step up on solid surface&#xD;
sit-to-stand&#xD;
step onto slippery surface The guarding support will be provided by a robot</description>
    <arm_group_label>standard robotic guarding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Challneged balance task training with robotic guarding support</intervention_name>
    <description>Nine balance tasks where the subject is challenged to perform at a harder level of difficulty:&#xD;
long forward step&#xD;
forward reach&#xD;
push forward&#xD;
push backward&#xD;
step over hurdle&#xD;
step up on foam surface&#xD;
step up on solid surface&#xD;
sit-to-stand&#xD;
step onto slippery surface The guarding support will be provided by a robot</description>
    <arm_group_label>challenge based robotic guarding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 6 months post-stroke&#xD;
&#xD;
          -  post-stroke hemiparesis&#xD;
&#xD;
          -  1.0 m/sec or slower walking speed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  musculoskeletal injury&#xD;
&#xD;
          -  recent history of cardiac event&#xD;
&#xD;
          -  other neurological disease or disorders&#xD;
&#xD;
          -  inability to follow three-step commands&#xD;
&#xD;
          -  uncontrolled diabetes and/or high blood pressure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Locomotor Control Lab</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02990650
org study id: STU00001977
nct id: NCT02990650
lead sponsor: 
collaborator: 
has dmc: No
Using a randomized controlled research design, compare walking outcomes resulting from gait
      and balance training with standard physical therapist interaction versus training with the
      addition of a KineAssist® robotic system that provides for safety and freedom of movement.
Several studies have investigated the use of balance and gait training and have demonstrated
      significant improvements in walking speed with trained stroke survivors. The inherent risks
      associated with balance and gait training requires the therapist to be vigilant with
      providing safety and support during challenging tasks. As a result, consumers are not
      challenged to their furthest limits and therapists put an inordinate amount of physical
      effort into safety control. KineAssist® Design, LLC in collaboration with Rehabilitation
      Institute of Chicago, developed the KineAssist® Balance and Gait Training System
      (KineAssist®). The KineAssist® is a novel device that allows full freedom of motion for the
      trunk and pelvis during gait and balance tasks, with additional postural control to enhance
      balance stability. These functions are available while the device follows the individual
      overground with minimal interference. The availability of postural control during complex and
      omnidirectional movement tasks allows the clinician to guarantee consumer safety and body
      weight support while at the same time provide graded task challenges to the fullest limits of
      the consumers capabilities. This KineAssist® is revolutionary in that it is the first device
      that is fully interactive and responsive to the movements and intentions of both the consumer
      and the therapist during overground challenging balance and gait activities.

      Accordingly, the long-term objective of this research is to test the efficacy of robotically
      enhanced, progressive gait and balance training for improving walking outcomes post-stroke.
      The following two aims are designed to test whether the KineAssist® provides a more
      challenging training environment than is typical with physical therapy, and then compares
      walking outcomes as a result of long-term (6 weeks) training.

      Aim: Using a randomized controlled research design, compare walking outcomes resulting from
      gait and balance training with standard physical therapist interaction versus training with
      the addition of a KineAssist®t.

      Overall, these studies are an important advance for the development of effective clinical
      interventions for individuals with impaired locomotor ability post-stroke. This study will
      provide critical information on physiological effects and clinical outcomes and provide
      important evidence for the use of this new class of robotic technology that accommodates both
      the clinician and the consumer in stroke rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean time of 10 meter walk test at baseline
time frame: baseline
measure: Mean time of 10 meter walk test at 3 weeks post baseline
time frame: 3 weeks post baseline
measure: Mean time of 10 meter walk test at 6 weeks at end of training
time frame: 6 weeks post baseline
measure: Mean time of 10 meter walk test at 6 months post training
time frame: 6 months post end of training
measure: Mean time of 6 minute walk test at baseline
time frame: baseline
measure: Mean time of 6 minute walk test at 3 weeks post baseline
time frame: 3 weeks post baseline
measure: Mean time of 6 minute walk test at 6 weeks post baseline (end of training)
time frame: 6 weeks post baseline (end of training)
measure: Mean time of 6 minute walk test at 6 months post training
time frame: 6 months post end of training (7.5 months post baseline)
measure: Mean Berg Balance Scale score at baseline
time frame: baseline
description: The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.
measure: Mean Berg Balance Scale score at 3 weeks post baseline
time frame: 3 weeks post baseline
description: The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.
measure: Mean Berg Balance Scale score at 6 weeks post baseline (end of training)
time frame: 6 weeks post baseline
description: The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.
measure: Mean Berg Balance Scale score at 6 months post end of training
time frame: 6 months post end of training (7.5 months post baseline)
description: The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.
arm group label: Standard physical therapist
arm group type: Active Comparator
description: A combination of nine balance training tasks where the physical therapist provides guarding against loss of balance
arm group label: standard robotic guarding
arm group type: Experimental
description: A combination of nine balance training tasks where the robotic system provides guarding against loss of balance
arm group label: challenge based robotic guarding
arm group type: Experimental
description: A combination of nine balance training tasks where the robotic system provides guarding against loss of balance while the participant works at a level greater than their current balance capability
intervention type: Behavioral
intervention name: Balance Task Training with therapist guarding support
description: Nine balance tasks:
long forward step
forward reach
push forward
push backward
step over hurdle
step up on foam surface
step up on solid surface
sit-to-stand
step onto slippery surface The therapist will provide guarding support
arm group label: Standard physical therapist
intervention type: Behavioral
intervention name: Balance task training with robotic guarding support
description: Nine balance tasks:
long forward step
forward reach
push forward
push backward
step over hurdle
step up on foam surface
step up on solid surface
sit-to-stand
step onto slippery surface The guarding support will be provided by a robot
arm group label: standard robotic guarding
intervention type: Behavioral
intervention name: Challneged balance task training with robotic guarding support
description: Nine balance tasks where the subject is challenged to perform at a harder level of difficulty:
long forward step
forward reach
push forward
push backward
step over hurdle
step up on foam surface
step up on solid surface
sit-to-stand
step onto slippery surface The guarding support will be provided by a robot
arm group label: challenge based robotic guarding
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke