<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/NCT04411108</url>
  </required_header>
  <id_info>
    <org_study_id>KaiaMC001</org_study_id>
    <nct_id>NCT04411108</nct_id>
  </id_info>
  <brief_title>Motion Coaching Technology for Physical Therapy in Low Back Pain.</brief_title>
  <official_title>Validation of Motion Coaching Technology for Physical Therapy in Treating Patients With Chronic, Nonspecific Low Back Pain. A Pilot Project.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaia Health Software</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaia Health Software</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>
      In this study, we will compare exercise execution between two groups of patients: (1)&#xD;
      individuals who undergo instruction session by a PT and then perform exercises with a written&#xD;
      handout at home and (2) individuals who use the mHealth motion coach at home. Participants&#xD;
      will perform the same 4 exercises. Both groups will be instructed to exercise at home,&#xD;
      supported either by the handouts or the Motion Coach technology and then return after 1 week&#xD;
      for assessment.&#xD;
&#xD;
      For the assessment, standardized videos will be used to capture pose during exercise&#xD;
      execution. Group 1 will perform the exercises with the written handout; group 2 will perform&#xD;
      the exercises with the motion coach. Rating will be performed by a panel of PT professionals&#xD;
      on the overall assessment of each exercises and on the three segments mentioned below that&#xD;
      are exercise specific. The first group with PT instruction and written handout portion will&#xD;
      be compared to the second group with the motion coach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2020</start_date>
  <completion_date type="Actual">September 27, 2021</completion_date>
  <primary_completion_date type="Actual">September 27, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scoring of each individual exercise rated by a panel of physiotherapists</measure>
    <time_frame>7 days</time_frame>
    <description>A panel of 5 physiotherapists each rates every repetition recorded as acceptable or not. If greater than 90% are rated as acceptable, the exercise will be assessed as acceptable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rating of exercise execution concerning specific body regions by physiotherapists</measure>
    <time_frame>7 days</time_frame>
    <description>For predefined segments for every exercise, a panel of physiotherapists scores execution quality on a scale of 0-3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Exercise Instruction by PT and written handout</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise Instruction by Motion Coach Technology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kaia Back Pain App</intervention_name>
    <description>The Kaia Back Pain App provides instructions on exercise execution to participants for one week</description>
    <arm_group_label>Exercise Instruction by Motion Coach Technology</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapist Exercise Instructions and written handouts</intervention_name>
    <description>Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week</description>
    <arm_group_label>Exercise Instruction by PT and written handout</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 22 - 65&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Absence of neurologic deficits as assessed by the clinician, with 5/5 strength in all&#xD;
             muscle groups in the lower extremities and no sensory deficits in the lower&#xD;
             extremities&#xD;
&#xD;
          -  Pain located in the low back or posterior pelvic region&#xD;
&#xD;
          -  Self-reported mean pain score &gt;4 in the past 1 week as assessed by VAS pain score from&#xD;
             0-10&#xD;
&#xD;
          -  Pain duration &gt;1 month to 5 years&#xD;
&#xD;
          -  Ambulatory w/out assist prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Red flag signs including fevers, unexplained weight loss, personal history of cancer,&#xD;
             tuberculosis exposure, history of spinal infection, history of thoracolumbar spine&#xD;
             fracture in the past year as assessed by the clinician.&#xD;
&#xD;
          -  Use of assistive ambulatory device&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Formal physical therapy within the past 6 months&#xD;
&#xD;
          -  Neurologic symptoms including weakness or sensory changes in the bilateral lower&#xD;
             extremities as assessed by the clinician.&#xD;
&#xD;
          -  Pain radiating below the posterior pelvic region into either lower extremity&#xD;
&#xD;
          -  Unwilling or unable to commit to study procedures&#xD;
&#xD;
          -  Physically incapable of completing PT exercises safely as determined by clinician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 9, 2022</last_update_submitted>
  <last_update_submitted_qc>August 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2022</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>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT04411108
org study id: KaiaMC001
nct id: NCT04411108
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, we will compare exercise execution between two groups of patients: (1)
      individuals who undergo instruction session by a PT and then perform exercises with a written
      handout at home and (2) individuals who use the mHealth motion coach at home. Participants
      will perform the same 4 exercises. Both groups will be instructed to exercise at home,
      supported either by the handouts or the Motion Coach technology and then return after 1 week
      for assessment.

      For the assessment, standardized videos will be used to capture pose during exercise
      execution. Group 1 will perform the exercises with the written handout; group 2 will perform
      the exercises with the motion coach. Rating will be performed by a panel of PT professionals
      on the overall assessment of each exercises and on the three segments mentioned below that
      are exercise specific. The first group with PT instruction and written handout portion will
      be compared to the second group with the motion coach.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Scoring of each individual exercise rated by a panel of physiotherapists
time frame: 7 days
description: A panel of 5 physiotherapists each rates every repetition recorded as acceptable or not. If greater than 90% are rated as acceptable, the exercise will be assessed as acceptable.
measure: Rating of exercise execution concerning specific body regions by physiotherapists
time frame: 7 days
description: For predefined segments for every exercise, a panel of physiotherapists scores execution quality on a scale of 0-3
arm group label: Exercise Instruction by PT and written handout
arm group type: Active Comparator
arm group label: Exercise Instruction by Motion Coach Technology
arm group type: Experimental
intervention type: Other
intervention name: Kaia Back Pain App
description: The Kaia Back Pain App provides instructions on exercise execution to participants for one week
arm group label: Exercise Instruction by Motion Coach Technology
intervention type: Other
intervention name: Physiotherapist Exercise Instructions and written handouts
description: Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week
arm group label: Exercise Instruction by PT and written handout
criteria: 
gender: All
minimum age: 22 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No