<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/NCT03264235</url>
  </required_header>
  <id_info>
    <org_study_id>NUSTU00205454</org_study_id>
    <nct_id>NCT03264235</nct_id>
  </id_info>
  <brief_title>The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA</brief_title>
  <official_title>The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Department of Education</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis/Specific Aims: The purpose of this research study is to determine if using an&#xD;
      exoskeleton during stair climbing training will result in an improved ability to walk and&#xD;
      climb stairs in individuals affected by recent stroke as compared to stair climbing training&#xD;
      without an exoskeleton.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton&#xD;
      device while completing all training sessions. Group 2 will not wear the exoskeleton device&#xD;
      during training sessions. All screening and evaluation sessions will be completed without the&#xD;
      exoskeleton device for both Group 1 and Group 2. Pre and post-session vitals (blood pressure,&#xD;
      heart rate) will be taken and monitored throughout the session as needed. Gait belts and/or&#xD;
      overhead track and harnessing systems will be used throughout sessions as needed for&#xD;
      increased safety of participants. Skin integrity will also be monitored both before and after&#xD;
      each use of the exoskeleton device.&#xD;
&#xD;
      Each enrolled participant will complete the following sessions:&#xD;
&#xD;
      Session 1: Screening&#xD;
&#xD;
        -  After consenting, subjects will undergo a physical evaluation and screening exam by a&#xD;
           licensed physical therapist. If they meet study criteria, they will be randomly placed&#xD;
           into either the Keeogo group or the traditional stair training group using a random&#xD;
           number generator and they will be entered into the study. Once they are enrolled,&#xD;
           baseline outcome measures will be assessed.&#xD;
&#xD;
      Sessions 2 through 6: Training&#xD;
&#xD;
        -  Subjects will participate in 30 minutes of stair training with or without the&#xD;
           exoskeleton device, depending on group assignment.&#xD;
&#xD;
      Session 7: Post-Testing&#xD;
&#xD;
        -  Outcomes measures will once again be assessed by a licensed physical therapist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 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>Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions and will participate in 30 minutes of stair training in the device. Group 2 will not wear the exoskeleton device during training sessions and will be participate in 30 minutes of stair training without the device.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Timed Stair Climb Test speed from baseline</measure>
    <time_frame>Initial Visit (Week 1); Post testing (Week 2)</time_frame>
    <description>The timed stair test is best conducted in a standard interior stair-well with guard rails and preferably 10 steps between landings, with a minimum of 8 steps and a maximum of 12 steps. The landing space is required to ensure safe turning. The patient will be instructed to ascend and descend the stair case &quot;as quickly and safely&quot; as possible.&#xD;
To start the test, the patient is asked to stand at the bottom of the stair case, and a countdown provided &quot;one, two, ready, go&quot; where the patient initiates stair ascent at the &quot;go&quot; cue, and the tester starts the stop watch.&#xD;
• The patient ascends the stair case, turns and descends the stair case, coming to a stop at the bottom of the stair case. The tester will lap the time for the ascent period and the descend period, and records these &quot;Test 1&quot; times.&#xD;
This will be repeated for a total of two trials.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>5-times Sit to Stand Test</measure>
    <time_frame>Initial Visit (Week 1); Post testing (Week 2)</time_frame>
    <description>Method:&#xD;
Use a straight back chair with a solid seat that is 16&quot; high. Ask participant to sit on the chair with arms folded across their chest.&#xD;
Instructions:&#xD;
&quot;Stand up and sit down as quickly as possible 5 times, keeping your arms folded across your chest.&quot;&#xD;
Measurement:&#xD;
Stop timing when the participant stands the 5th time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAITRite Data Collection</measure>
    <time_frame>Initial Visit (Week 1); Post testing (Week 2)</time_frame>
    <description>The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter &quot;flying start&quot; to compensate for initial acceleration.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Stroke, Acute</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <arm_group>
    <arm_group_label>Group 1 Exoskeleton</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both training groups will undergo inpatient physical therapy of the same duration and intensity. Group 1 will complete stair training wearing the Keeogo Exoskeleton in inpatient physical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 Traditional Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 2 will complete traditional stair training in inpatient physical therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Keeogo</intervention_name>
    <description>Keeogo is a computer-controlled lower extremity motorized orthosis worn over the user's hips and legs. The controller box contains sensors that supply information about the kinematics and the kinetics of the user's lower extremities and includes software that recognizes the user's mobility intentions. The system is powered by a lithium-polymer battery. The leg brace assembly is mainly comprised of the actuator, the electronic boards, hip joint, and soft goods (cuffs, belts) for affixing the assembly to the user's legs. The waist belt comes in various sizes adapted to each wearer, and adds additional support of the device on the user.&#xD;
Keeogo does not initiate any movement but waits for the user's lead. Once the user makes the first move, Keeogo assists according to the activity. The individual must be able to initiate and terminate steps.</description>
    <arm_group_label>Group 1 Exoskeleton</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Stair Training</intervention_name>
    <description>Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 1.</description>
    <arm_group_label>Group 2 Traditional Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient in the inpatient rehabilitation setting&#xD;
&#xD;
          -  less that 3 months post-hemorrhagic or ischemic cerebrovascular accident (CVA)&#xD;
&#xD;
          -  No previous diagnosis or treatment for CVA&#xD;
&#xD;
          -  Acute inpatient rehabilitation discharge goal of stair negotiation&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Waist and leg circumference and lower extremity lengths appropriate for a comfortable&#xD;
             and safe fit in the Keeogo study device&#xD;
&#xD;
          -  Medical clearance from a Shirley Ryan AbilityLab (SRALAB) inpatient physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to participate&#xD;
&#xD;
          -  Unable to provide autonomous consent due to cognitive or communication impairment&#xD;
&#xD;
          -  Legally blind&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Skin condition that contraindicates use of orthotics or support braces&#xD;
&#xD;
          -  History of multiple CVA&#xD;
&#xD;
          -  History of any additional neuropathology diagnosis, such as Parkinson's disease,&#xD;
             multiple sclerosis, traumatic brain injury, or spinal cord injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arun Jayaraman, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan Ability Lab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shirley Ryan Ability Lab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shirley Ryan AbilityLab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Arun Jayaraman, PT, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Powered-Knee Exoskeleton</keyword>
  <keyword>Stair Training</keyword>
  <keyword>Keeogo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03264235
org study id: NUSTU00205454
nct id: NCT03264235
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Hypothesis/Specific Aims: The purpose of this research study is to determine if using an
      exoskeleton during stair climbing training will result in an improved ability to walk and
      climb stairs in individuals affected by recent stroke as compared to stair climbing training
      without an exoskeleton.
Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton
      device while completing all training sessions. Group 2 will not wear the exoskeleton device
      during training sessions. All screening and evaluation sessions will be completed without the
      exoskeleton device for both Group 1 and Group 2. Pre and post-session vitals (blood pressure,
      heart rate) will be taken and monitored throughout the session as needed. Gait belts and/or
      overhead track and harnessing systems will be used throughout sessions as needed for
      increased safety of participants. Skin integrity will also be monitored both before and after
      each use of the exoskeleton device.

      Each enrolled participant will complete the following sessions:

      Session 1: Screening

        -  After consenting, subjects will undergo a physical evaluation and screening exam by a
           licensed physical therapist. If they meet study criteria, they will be randomly placed
           into either the Keeogo group or the traditional stair training group using a random
           number generator and they will be entered into the study. Once they are enrolled,
           baseline outcome measures will be assessed.

      Sessions 2 through 6: Training

        -  Subjects will participate in 30 minutes of stair training with or without the
           exoskeleton device, depending on group assignment.

      Session 7: Post-Testing

        -  Outcomes measures will once again be assessed by a licensed physical therapist.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions and will participate in 30 minutes of stair training in the device. Group 2 will not wear the exoskeleton device during training sessions and will be participate in 30 minutes of stair training without the device.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Timed Stair Climb Test speed from baseline
time frame: Initial Visit (Week 1); Post testing (Week 2)
description: The timed stair test is best conducted in a standard interior stair-well with guard rails and preferably 10 steps between landings, with a minimum of 8 steps and a maximum of 12 steps. The landing space is required to ensure safe turning. The patient will be instructed to ascend and descend the stair case "as quickly and safely" as possible.
To start the test, the patient is asked to stand at the bottom of the stair case, and a countdown provided "one, two, ready, go" where the patient initiates stair ascent at the "go" cue, and the tester starts the stop watch.
• The patient ascends the stair case, turns and descends the stair case, coming to a stop at the bottom of the stair case. The tester will lap the time for the ascent period and the descend period, and records these "Test 1" times.
This will be repeated for a total of two trials.
measure: 5-times Sit to Stand Test
time frame: Initial Visit (Week 1); Post testing (Week 2)
description: Method:
Use a straight back chair with a solid seat that is 16" high. Ask participant to sit on the chair with arms folded across their chest.
Instructions:
"Stand up and sit down as quickly as possible 5 times, keeping your arms folded across your chest."
Measurement:
Stop timing when the participant stands the 5th time.
measure: GAITRite Data Collection
time frame: Initial Visit (Week 1); Post testing (Week 2)
description: The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter "flying start" to compensate for initial acceleration.
arm group label: Group 1 Exoskeleton
arm group type: Experimental
description: Both training groups will undergo inpatient physical therapy of the same duration and intensity. Group 1 will complete stair training wearing the Keeogo Exoskeleton in inpatient physical therapy.
arm group label: Group 2 Traditional Therapy
arm group type: Active Comparator
description: Group 2 will complete traditional stair training in inpatient physical therapy.
intervention type: Device
intervention name: Keeogo
description: Keeogo is a computer-controlled lower extremity motorized orthosis worn over the user's hips and legs. The controller box contains sensors that supply information about the kinematics and the kinetics of the user's lower extremities and includes software that recognizes the user's mobility intentions. The system is powered by a lithium-polymer battery. The leg brace assembly is mainly comprised of the actuator, the electronic boards, hip joint, and soft goods (cuffs, belts) for affixing the assembly to the user's legs. The waist belt comes in various sizes adapted to each wearer, and adds additional support of the device on the user.
Keeogo does not initiate any movement but waits for the user's lead. Once the user makes the first move, Keeogo assists according to the activity. The individual must be able to initiate and terminate steps.
arm group label: Group 1 Exoskeleton
intervention type: Other
intervention name: Traditional Stair Training
description: Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 1.
arm group label: Group 2 Traditional Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arun Jayaraman, PT, PhD
role: Principal Investigator
affiliation: Shirley Ryan Ability Lab
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Arun Jayaraman, PT, PhD
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic
sharing ipd: No