<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/NCT03760380</url>
  </required_header>
  <id_info>
    <org_study_id>OCR17682</org_study_id>
    <nct_id>NCT03760380</nct_id>
  </id_info>
  <brief_title>Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions</brief_title>
  <official_title>Pilot Study: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions on Knee Osteoarthritis Acutely and Over a 12 Week Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Scientific Motion Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study involves the use of a newly designed shoe device for knee arthritis patients that&#xD;
      may help reduce knee pain and improve function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study involves the use of a newly designed shoe device for knee arthritis patients that&#xD;
      may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate&#xD;
      knee pain and function in healthy participants with a history of medial knee arthritis.&#xD;
&#xD;
      The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's&#xD;
      walking gait and balance over a single day; and 2. how using the shoe device over the course&#xD;
      of a 12-week period will affect a person's walking gait and balance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    sponsor funding shortage&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 16, 2019</start_date>
  <completion_date type="Actual">November 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Phase 1 All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset)&#xD;
Phase 2 Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in NRS pain (Pain Numeric Rating Scale) score.</measure>
    <time_frame>Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12</time_frame>
    <description>Participants selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as one can imagine&quot; or &quot;worst pain imaginable&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score</measure>
    <time_frame>Baseline (Phase 2), Week 4, Week 8, Week 12</time_frame>
    <description>Self-administered questionnaire consisting of 24 items divided into 3 subscales [total score 0-96; subscales from 0-20 (pain)/0-8(stiffness)/0-68(physical function)]. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-36 disability score.</measure>
    <time_frame>Baseline (Phase 2), Week 4, Week 8, Week 12</time_frame>
    <description>Eight scaled scores, where each scale is directly transformed into a 0-100 scale. The lower the score the more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Timed Up &amp; Go (TUG) Test score.</measure>
    <time_frame>Baseline (Phase 2), Week 4, Week 8, Week 12</time_frame>
    <description>Time it takes for participant to rise from chair, walk 3 meters, turn around, walk back and sit down.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stair Climb time score.</measure>
    <time_frame>Baseline (Phase 2), Week 4, Week 8, Week 12</time_frame>
    <description>Time it takes participant to walk up on flight of stairs (12 steps).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>Phase 1 Short Term</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will serve as their own control. Questionnaires and gait measures will be collected during an initial visit using the experimental shoe device. All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 Long Term</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will serve as their own control. Questionnaires, balance, functional and gait measures will be collected during four different visits over a twelve week period (once at baseline visit, 4, 8, and 12 week visits) using the experimental shoe device. Patients will also complete a home walking program using the shoe device over the twelve week period. Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sole 1 - Neutral</intervention_name>
    <description>Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability. This is defined as the location which creates the smallest amount of instability.</description>
    <arm_group_label>Phase 1 Short Term</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sole 1 - Offset</intervention_name>
    <description>Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.</description>
    <arm_group_label>Phase 1 Short Term</arm_group_label>
    <arm_group_label>Phase 2 Long Term</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sole 2 - Neutral</intervention_name>
    <description>Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability.This is defined as the location which creates the smallest amount of instability.</description>
    <arm_group_label>Phase 1 Short Term</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sole 2 - Offset</intervention_name>
    <description>Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.</description>
    <arm_group_label>Phase 1 Short Term</arm_group_label>
    <arm_group_label>Phase 2 Long Term</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic, OA-related knee pain&#xD;
&#xD;
          -  Diagnosis of medial compartment knee OA (unilateral or bilateral)&#xD;
&#xD;
          -  Moderate pain of ≥4 out of 10 points while performing a weight-bearing activity&#xD;
&#xD;
          -  Kellgren and Lawrence score of 2, 3, or 4 evidenced on routine, standard-of-care x-ray&#xD;
             within the last 2 years prior to enrollment&#xD;
&#xD;
          -  Able to walk unassisted for at least 10 minutes at a time&#xD;
&#xD;
          -  Wear a Women's shoe size of 6.5 to 13 or a Men's shoe size of 5 to 12.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from acute septic or inflammatory arthritis&#xD;
&#xD;
          -  Unstable cardiovascular, orthopaedic, or neurological conditions, uncontrolled&#xD;
             diabetes, or any condition that would preclude exercise in moderate duration, moderate&#xD;
             workload trials&#xD;
&#xD;
          -  Received a corticosteroid injection or invasive procedures within prior 6 months of&#xD;
             the study&#xD;
&#xD;
          -  History of avascular necrosis in the knee&#xD;
&#xD;
          -  History of knee buckling&#xD;
&#xD;
          -  Joint replacement in any lower extremity joint that has not optimally recovered (e.g.&#xD;
             still causes significant pain or affects mobility) as determined by the PI.&#xD;
&#xD;
          -  Experienced more than 3 falls within the last year&#xD;
&#xD;
          -  Currently using any knee brace on a regular basis for the knee pain, with the&#xD;
             exception of basic knee sleeves&#xD;
&#xD;
          -  Pathological osteoporotic fracture&#xD;
&#xD;
          -  Severe symptomatic degenerative arthritis in lower limb joints other than the knees&#xD;
&#xD;
          -  Severe back pain, prior spinal fusion or spinal deformity that would affect gait&#xD;
&#xD;
          -  Major cardiac or pulmonary conditions and any orthopedic limitation that precludes&#xD;
             their ability to independently walk for 10 minutes or longer&#xD;
&#xD;
          -  Knee flexion contracture greater than 15°&#xD;
&#xD;
          -  Knee flexion of less than 90°&#xD;
&#xD;
          -  Any major injury to either knee within the prior 12 months&#xD;
&#xD;
          -  Currently enrolled in a supervised physical therapy program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hari K Parvataneni</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis (OA)</keyword>
  <keyword>gait modifying shoe</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT03760380
org study id: OCR17682
nct id: NCT03760380
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study involves the use of a newly designed shoe device for knee arthritis patients that
      may help reduce knee pain and improve function.
This study involves the use of a newly designed shoe device for knee arthritis patients that
      may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate
      knee pain and function in healthy participants with a history of medial knee arthritis.

      The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's
      walking gait and balance over a single day; and 2. how using the shoe device over the course
      of a 12-week period will affect a person's walking gait and balance.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Phase 1 All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset)
Phase 2 Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use.
primary purpose: Other
masking: None (Open Label)
measure: Change in NRS pain (Pain Numeric Rating Scale) score.
time frame: Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12
description: Participants selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as one can imagine" or "worst pain imaginable").
measure: Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
time frame: Baseline (Phase 2), Week 4, Week 8, Week 12
description: Self-administered questionnaire consisting of 24 items divided into 3 subscales [total score 0-96; subscales from 0-20 (pain)/0-8(stiffness)/0-68(physical function)]. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
measure: Change in SF-36 disability score.
time frame: Baseline (Phase 2), Week 4, Week 8, Week 12
description: Eight scaled scores, where each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
measure: Change in Timed Up & Go (TUG) Test score.
time frame: Baseline (Phase 2), Week 4, Week 8, Week 12
description: Time it takes for participant to rise from chair, walk 3 meters, turn around, walk back and sit down.
measure: Change in Stair Climb time score.
time frame: Baseline (Phase 2), Week 4, Week 8, Week 12
description: Time it takes participant to walk up on flight of stairs (12 steps).
arm group label: Phase 1 Short Term
arm group type: Experimental
description: Participants will serve as their own control. Questionnaires and gait measures will be collected during an initial visit using the experimental shoe device. All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset)
arm group label: Phase 2 Long Term
arm group type: Experimental
description: Participants will serve as their own control. Questionnaires, balance, functional and gait measures will be collected during four different visits over a twelve week period (once at baseline visit, 4, 8, and 12 week visits) using the experimental shoe device. Patients will also complete a home walking program using the shoe device over the twelve week period. Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use.
intervention type: Device
intervention name: Sole 1 - Neutral
description: Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability. This is defined as the location which creates the smallest amount of instability.
arm group label: Phase 1 Short Term
intervention type: Device
intervention name: Sole 1 - Offset
description: Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.
arm group label: Phase 1 Short Term
arm group label: Phase 2 Long Term
intervention type: Device
intervention name: Sole 2 - Neutral
description: Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability.This is defined as the location which creates the smallest amount of instability.
arm group label: Phase 1 Short Term
intervention type: Device
intervention name: Sole 2 - Offset
description: Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.
arm group label: Phase 1 Short Term
arm group label: Phase 2 Long Term
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hari K Parvataneni
role: Principal Investigator
affiliation: University of Florida
country: United States
responsible party type: Sponsor
mesh term: Arthritis
sharing ipd: No