<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/NCT02243332</url>
  </required_header>
  <id_info>
    <org_study_id>ALI-KS-001</org_study_id>
    <nct_id>NCT02243332</nct_id>
  </id_info>
  <brief_title>Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain</brief_title>
  <official_title>Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Articulate Labs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Articulate Labs</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this small, pilot study is to evaluate a novel device that uses neuromuscular&#xD;
      electrical stimulation to assist quadriceps muscles as a user walks. This study will involve&#xD;
      use of this device on individuals with patellofemoral pain, a relatively common injury among&#xD;
      active people, to see if quadriceps stimulation could mitigate disparities in quadriceps&#xD;
      activation timing that may indirectly lead to knee pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The interventional device will be tested with 20 women aged 18-40 with evidence of&#xD;
      patellofemoral pain syndrome (PFPS) and without any co-morbidities that would confound data&#xD;
      or contraindications for NMES use. All participants will be enrolled at a single site&#xD;
      (Developmental Motor Lab at the University of Texas), and all of a single participant's&#xD;
      testing will be complete within a single day with no requirement for follow-up or long-term&#xD;
      participation. Participants will have their gait and quadriceps muscle activation patterns&#xD;
      evaluated through four six-minute walk tests (6MWT). The first 6MWT will be without a device,&#xD;
      second with a device worn but not activated, third with a device activated and stimulating&#xD;
      quadriceps musculature, and the fourth without a device.&#xD;
&#xD;
      Primary Objective: The purpose of this study is to investigate whether electrical stimulation&#xD;
      of the vastus medalis (VM) and/or vastus lateralis (VL) to establish coactivation of these&#xD;
      muscles during terminal swing phase impacts severity of PFPS symptoms&#xD;
&#xD;
      Secondary Objectives: Secondary purposes for this study include evaluating KneeStim and&#xD;
      seeing if there is any evidence of proof of concept in two main areas:&#xD;
&#xD;
      KneeStim as a therapeutic device that may assist individuals with joint rehabilitation&#xD;
      KneeStim's on-board operating system and motion tracking system as an effective way to&#xD;
      monitor joint kinematics.&#xD;
&#xD;
      This pilot study has a prospective, controlled, single-center design. Participants and&#xD;
      investigators will not be blinded to the treatment. Individuals who evaluate the&#xD;
      motion-tracking data between VICON and KneeStim will not be informed which data set aligns&#xD;
      with which treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measured Quadriceps Musculature Co-Contraction</measure>
    <time_frame>20, 40, 60, 80 minutes from start of single-day testing</time_frame>
    <description>Electromyographic (EMG) readings of vastus lateralis and vastus medialis contraction patterns will be taken after four six-minute walk tests (6MWTs) to evaluate any short-term changes in co-contraction.&#xD;
6MWT #1: Without interventional device being worn; 6MWT #2: With interventional device being worn, but unpowered; 6MWT #3: With interventional device being worn and operational; 6MWT #4: Without interventional device being worn&#xD;
The time period in which a partipant will be involved is not expected to exceed 90 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anterior Knee Pain</measure>
    <time_frame>20, 40, 60, 80 minutes from start of single-day testing</time_frame>
    <description>Measured with Anterior Knee Pain Scale (AKPS) after each Six Minute Walk Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Joint Model Accuracy</measure>
    <time_frame>20, 40, 60, 80 minutes from start of single-day testing</time_frame>
    <description>The interventional device uses an on-board operating system that determines stimulation timing and location based on modeled joint kinematics. Movement data will be taken from the device and evaluated against movement data measured by a VICON motion-tracking system during each six-minute walk test to evaluate the accuracy of the device's modeled joint kinematics.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <condition>Anterior Knee Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Device (rehabilitation assistance)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: KneeStim mobile rehabilitation assistance device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KneeStim mobile rehabilitation assistance device</intervention_name>
    <description>KneeStim is a neuromuscular electrical stimulation (NMES) device that integrates motion-tracking hardware like three-axis accelerometers and a real-time operating system to enable quadriceps muscle stimulation in time with user gait. It is a completely non-invasive device that looks like a light brace and fastens to the user's quadriceps and gastrocnemius muscles. The end goal of this device is to assist with muscle re-strengthening and re-education during a user's everyday activities.</description>
    <arm_group_label>Device (rehabilitation assistance)</arm_group_label>
    <other_name>KneeStim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-40 years&#xD;
&#xD;
          -  Symptomatic PFPS on Patella Glide Test, Patella Tilt Test, and Patellar Apprehension&#xD;
             Test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis or inflammatory arthritis as assessed by licensed physician&#xD;
&#xD;
          -  Use of walking aids other than a cane more than 50% of the time in ambulation&#xD;
&#xD;
          -  Diagnosed knee disorder other than patellofemoral syndrome&#xD;
&#xD;
          -  Pacemaker use, unstable angina, or decompensated heart failure&#xD;
&#xD;
          -  Knee replaced in preceding 12 months or replacement planned within 6 months&#xD;
&#xD;
          -  Moderate to severe dementia&#xD;
&#xD;
          -  Pregnancy (self report)&#xD;
&#xD;
          -  Altered sensation at the knee such that the patient is unable to perceive the presence&#xD;
             of pinprick.&#xD;
&#xD;
          -  Use of intra-articular viscosupplementation or steroid injection within preceding 2&#xD;
             months.&#xD;
&#xD;
          -  Use of chronic anticoagulation medication.&#xD;
&#xD;
          -  Movement-limiting pain in the back, hip, ankle, or foot of either lower limb.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Griffin, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas at Austin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Developmental Motor Control Lab; University of Texas at Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee</keyword>
  <keyword>Pain</keyword>
  <keyword>Joint</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Patellofemoral Pain Syndrome</keyword>
  <keyword>Anterior Knee Pain Syndrome</keyword>
  <keyword>Knee Pain</keyword>
  <keyword>Quadriceps</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT02243332
org study id: ALI-KS-001
nct id: NCT02243332
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this small, pilot study is to evaluate a novel device that uses neuromuscular
      electrical stimulation to assist quadriceps muscles as a user walks. This study will involve
      use of this device on individuals with patellofemoral pain, a relatively common injury among
      active people, to see if quadriceps stimulation could mitigate disparities in quadriceps
      activation timing that may indirectly lead to knee pain.
The interventional device will be tested with 20 women aged 18-40 with evidence of
      patellofemoral pain syndrome (PFPS) and without any co-morbidities that would confound data
      or contraindications for NMES use. All participants will be enrolled at a single site
      (Developmental Motor Lab at the University of Texas), and all of a single participant's
      testing will be complete within a single day with no requirement for follow-up or long-term
      participation. Participants will have their gait and quadriceps muscle activation patterns
      evaluated through four six-minute walk tests (6MWT). The first 6MWT will be without a device,
      second with a device worn but not activated, third with a device activated and stimulating
      quadriceps musculature, and the fourth without a device.

      Primary Objective: The purpose of this study is to investigate whether electrical stimulation
      of the vastus medalis (VM) and/or vastus lateralis (VL) to establish coactivation of these
      muscles during terminal swing phase impacts severity of PFPS symptoms

      Secondary Objectives: Secondary purposes for this study include evaluating KneeStim and
      seeing if there is any evidence of proof of concept in two main areas:

      KneeStim as a therapeutic device that may assist individuals with joint rehabilitation
      KneeStim's on-board operating system and motion tracking system as an effective way to
      monitor joint kinematics.

      This pilot study has a prospective, controlled, single-center design. Participants and
      investigators will not be blinded to the treatment. Individuals who evaluate the
      motion-tracking data between VICON and KneeStim will not be informed which data set aligns
      with which treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Measured Quadriceps Musculature Co-Contraction
time frame: 20, 40, 60, 80 minutes from start of single-day testing
description: Electromyographic (EMG) readings of vastus lateralis and vastus medialis contraction patterns will be taken after four six-minute walk tests (6MWTs) to evaluate any short-term changes in co-contraction.
6MWT #1: Without interventional device being worn; 6MWT #2: With interventional device being worn, but unpowered; 6MWT #3: With interventional device being worn and operational; 6MWT #4: Without interventional device being worn
The time period in which a partipant will be involved is not expected to exceed 90 minutes.
measure: Anterior Knee Pain
time frame: 20, 40, 60, 80 minutes from start of single-day testing
description: Measured with Anterior Knee Pain Scale (AKPS) after each Six Minute Walk Test.
measure: Device Joint Model Accuracy
time frame: 20, 40, 60, 80 minutes from start of single-day testing
description: The interventional device uses an on-board operating system that determines stimulation timing and location based on modeled joint kinematics. Movement data will be taken from the device and evaluated against movement data measured by a VICON motion-tracking system during each six-minute walk test to evaluate the accuracy of the device's modeled joint kinematics.
arm group label: Device (rehabilitation assistance)
arm group type: Experimental
description: Device: KneeStim mobile rehabilitation assistance device
intervention type: Device
intervention name: KneeStim mobile rehabilitation assistance device
description: KneeStim is a neuromuscular electrical stimulation (NMES) device that integrates motion-tracking hardware like three-axis accelerometers and a real-time operating system to enable quadriceps muscle stimulation in time with user gait. It is a completely non-invasive device that looks like a light brace and fastens to the user's quadriceps and gastrocnemius muscles. The end goal of this device is to assist with muscle re-strengthening and re-education during a user's everyday activities.
arm group label: Device (rehabilitation assistance)
other name: KneeStim
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Lisa Griffin, Ph.D.
role: Principal Investigator
affiliation: University of Texas at Austin
facility: 
country: United States
responsible party type: Sponsor
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Somatoform Disorders