xml: <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/NCT05994833</url>
    </required_header>
    <id_info>
      <org_study_id>IRB202301005</org_study_id>
      <nct_id>NCT05994833</nct_id>
    </id_info>
    <brief_title>Virtual Physical Therapy Support for Runners</brief_title>
    <official_title>Virtual Physical Therapy Support for Runners Receiving Gait Analyses for Lower Body Running Related Musculoskeletal Issues</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Florida</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will compare standard of care of home exercise for running rehabilitation to the&#xD;
        combined treatment of home exercise with an individually provided four-session virtual&#xD;
        physical therapy support program intervention on pain and physical function movements&#xD;
        (controlled dual and single leg squat and lateral hopping in individuals post running injury.&#xD;
        These collective findings will help provide new evidence of the responses to an individually&#xD;
        provided virtual PT interventions among runners.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">June 2030</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline numerical rating scale for pain (NRSpain) at 4 weeks</measure>
      <time_frame>Visits 6; one month post enrollment</time_frame>
      <description>A numerical rating scale for pain (NRSpain) will be used to assess changes in lower body related musculoskeletal pain at rest (now, average over the last week) and during weight bearing activity (like walking) on a range of lowest score of 0 (no pain) to 10 (worst pain)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline numerical rating scale for pain (NRSpain) at 6 months</measure>
      <time_frame>Visits 7; six months post enrollment</time_frame>
      <description>A numerical rating scale for pain (NRSpain) will be used to assess changes in lower body related musculoskeletal pain at rest (now, average over the last week) and during weight bearing activity (like walking) on a range of lowest score of 0 (no pain) to 10 (worst pain)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline squat quality on single leg (using dominant leg) at 4 weeks</measure>
      <time_frame>visit 6; one month post enrollment</time_frame>
      <description>Squat performance on the single leg (using dominant leg) will be scored on a range of scale 1 (best performance) to 3 (worst performance)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline squat quality on single leg (using dominant leg) at 6 months</measure>
      <time_frame>visit 7; six months post enrollment</time_frame>
      <description>Squat performance on the single leg (using dominant leg) will be scored on a range of scale 1 (best performance) to 3 (worst performance)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline squat quality on the dual leg at 4 weeks</measure>
      <time_frame>visit 6; one month post enrollment</time_frame>
      <description>Squat performance on the dual leg will be scored on a range of scale 1 (best performance) to 3 (worst performance)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline squat quality on the dual leg at 6 months</measure>
      <time_frame>visit 7; six months post enrollment</time_frame>
      <description>Squat performance on the dual leg will be scored on a range of scale 1 (best performance) to 3 (worst performance)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline standing stork quality (using dominant leg) at 4 weeks</measure>
      <time_frame>visit 6; one month post enrollment</time_frame>
      <description>Balance performance on the standing stork will be scored on the ranges of excellent to poor scale compared to the normative data published for males/females (Schell &amp; Leelarthaepin 1994)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline standing stork quality (using dominant leg) at 6 months</measure>
      <time_frame>visit 7; six months post enrollment</time_frame>
      <description>Balance performance on the standing stork will be scored on the ranges of excellent to poor scale compared to the normative data published for males/females (Schell &amp; Leelarthaepin 1994)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline hopping quality (using dominant leg) at 4 weeks</measure>
      <time_frame>visit 6; one month post enrollment</time_frame>
      <description>Quality performance on the hopping three times (using dominant leg) and land on the same limb as far as possible will be scored based on the distance hopped, measured at the level of the great toe on a range of scale 1 (best performance) to 3 (worst performance)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline hopping quality (using dominant leg) at 6 months</measure>
      <time_frame>visit 7; six months post enrollment</time_frame>
      <description>Quality performance on the hopping three times (using dominant leg) and land on the same limb as far as possible will be scored based on the distance hopped, measured at the level of the great toe on a range of scale 1 (best performance) to 3 (worst performance)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 4 weeks</measure>
      <time_frame>visit 6; one month post enrollment</time_frame>
      <description>A markerless motion system will be used. Cameras will be used to collect the backward-forward displacement during 20 sec of static standing on both legs will be analyzed for ability to control static balance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 6 months</measure>
      <time_frame>visit 7; six months post enrollment</time_frame>
      <description>A markerless motion system will be used. Cameras will be used to collect the backward-forward displacement during 20 sec of static standing on both legs will be analyzed for ability to control static balance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline gait speed at 4 weeks</measure>
      <time_frame>visit 6; one month post enrollment</time_frame>
      <description>Spatiotemporal parameters are analyzed [i.e. gait speed (meters/sec), cadence (steps/minute)]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline gait speed at 6 months</measure>
      <time_frame>visit 7; six months post enrollment</time_frame>
      <description>Spatiotemporal parameters are analyzed [i.e. gait speed (meters/sec), cadence (steps/minute)]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline displacement of the center of gravity in vertical direction at 4 weeks</measure>
      <time_frame>visit 6; one month post enrollment</time_frame>
      <description>Spatiotemporal parameters are analyzed (i.e. center of gravity vertical displacement measured in centimeters)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline displacement of the body in vertical direction at 6 months</measure>
      <time_frame>visit 7; six months post enrollment</time_frame>
      <description>Spatiotemporal parameters are analyzed (i.e. center of gravity vertical displacement measured in centimeters)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline displacement between strides at 4 weeks</measure>
      <time_frame>visit 6; one month post enrollment</time_frame>
      <description>Spatiotemporal parameters are analyzed (i.e. stride width measured in centimeters)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline displacement between strides at 6 months</measure>
      <time_frame>visit 7; six months post enrollment</time_frame>
      <description>Spatiotemporal parameters are analyzed (i.e. stride width measured in centimeters)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">85</enrollment>
    <condition>Musculoskeletal Complication</condition>
    <arm_group>
      <arm_group_label>paper-based standard care exercise program</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>VPT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>VPT</intervention_name>
      <description>The VPT will be comprised of weekly virtual visits with the participant for one month. During the visits, the physical therapist will review the exercises that were prescribed, adherence, provide feedback to the participant as they execute the exercises onscreen and make corrections, make any progression or adjustments to the exercises, review running cues they learned from the testing session and answer any questions. The therapist will also review any new activities that are initiated during the previous week (to control for confounders), changes in musculoskeletal pain and participation in running volume.</description>
      <arm_group_label>VPT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age of 18 to 65 years&#xD;
  &#xD;
            -  Regularly running at least 12 miles a week prior to development of musculoskeletal&#xD;
               complaint.&#xD;
  &#xD;
            -  Free of surgical history of surgery to either lower limb&#xD;
  &#xD;
            -  No history of major bony injury to the lower limb such as traumatic fracture, within&#xD;
               the past 12 months&#xD;
  &#xD;
            -  Presence of chronic lower body running related injuries (e.g., patellofemoral pain, IT&#xD;
               band syndrome, Achilles tendinitis, chronic lower back pain after running)&#xD;
  &#xD;
            -  Body mass index (BMI) &lt;=35 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  &lt; 18 or 65 years&#xD;
  &#xD;
            -  BMI &gt;35 kg/m2&#xD;
  &#xD;
            -  Mental disablement (down's syndrome or dementia)&#xD;
  &#xD;
            -  Any persons incarcerated, on parole, on probation, or awaiting trial.&#xD;
  &#xD;
            -  Individuals with neurologic or degenerative musculoskeletal disease, such as&#xD;
               rheumatoid arthritis, muscular dystrophy, or Parkinson's disease.&#xD;
  &#xD;
            -  Current acute running related or sport related injury (e.g., ankle sprain, hip labral&#xD;
               tear, ACL strain during an event or run)&#xD;
  &#xD;
            -  Individuals with a history of strong risk factors for poor fracture healing, such as&#xD;
               uncontrolled diabetes, chemotherapy, end-stage organ disease, dialysis or smoking&#xD;
  &#xD;
            -  Unwilling to forgo your potential in-person therapy visits for a month after&#xD;
               enrollment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sharareh Sharififar, PhD, PT</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Florida</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sharareh PhD, PT</last_name>
      <phone>3522738453</phone>
      <email>sharareh75@ufl.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jamie Bolliong</last_name>
      <phone>3522737412</phone>
      <email>jamiekbolling@ufl.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Florida College of medicine- Dept of PM&amp;R</name>
        <address>
          <city>Gainesville</city>
          <state>Florida</state>
          <zip>32607</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sharareh Sharififar, PhD, PT</last_name>
        <phone>352-273-8453</phone>
        <email>sharareh75@ufl.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994833
  org study id: IRB202301005
  nct id: NCT05994833
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will compare standard of care of home exercise for running rehabilitation to the
        combined treatment of home exercise with an individually provided four-session virtual
        physical therapy support program intervention on pain and physical function movements
        (controlled dual and single leg squat and lateral hopping in individuals post running injury.
        These collective findings will help provide new evidence of the responses to an individually
        provided virtual PT interventions among runners.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Change from baseline numerical rating scale for pain (NRSpain) at 4 weeks
  time frame: Visits 6; one month post enrollment
  description: A numerical rating scale for pain (NRSpain) will be used to assess changes in lower body related musculoskeletal pain at rest (now, average over the last week) and during weight bearing activity (like walking) on a range of lowest score of 0 (no pain) to 10 (worst pain)
  measure: Change from baseline numerical rating scale for pain (NRSpain) at 6 months
  time frame: Visits 7; six months post enrollment
  description: A numerical rating scale for pain (NRSpain) will be used to assess changes in lower body related musculoskeletal pain at rest (now, average over the last week) and during weight bearing activity (like walking) on a range of lowest score of 0 (no pain) to 10 (worst pain)
  measure: Change from baseline squat quality on single leg (using dominant leg) at 4 weeks
  time frame: visit 6; one month post enrollment
  description: Squat performance on the single leg (using dominant leg) will be scored on a range of scale 1 (best performance) to 3 (worst performance)
  measure: Change from baseline squat quality on single leg (using dominant leg) at 6 months
  time frame: visit 7; six months post enrollment
  description: Squat performance on the single leg (using dominant leg) will be scored on a range of scale 1 (best performance) to 3 (worst performance)
  measure: Change from baseline squat quality on the dual leg at 4 weeks
  time frame: visit 6; one month post enrollment
  description: Squat performance on the dual leg will be scored on a range of scale 1 (best performance) to 3 (worst performance)
  measure: Change from baseline squat quality on the dual leg at 6 months
  time frame: visit 7; six months post enrollment
  description: Squat performance on the dual leg will be scored on a range of scale 1 (best performance) to 3 (worst performance)
  measure: Change from baseline standing stork quality (using dominant leg) at 4 weeks
  time frame: visit 6; one month post enrollment
  description: Balance performance on the standing stork will be scored on the ranges of excellent to poor scale compared to the normative data published for males/females (Schell & Leelarthaepin 1994)
  measure: Change from baseline standing stork quality (using dominant leg) at 6 months
  time frame: visit 7; six months post enrollment
  description: Balance performance on the standing stork will be scored on the ranges of excellent to poor scale compared to the normative data published for males/females (Schell & Leelarthaepin 1994)
  measure: Change from baseline hopping quality (using dominant leg) at 4 weeks
  time frame: visit 6; one month post enrollment
  description: Quality performance on the hopping three times (using dominant leg) and land on the same limb as far as possible will be scored based on the distance hopped, measured at the level of the great toe on a range of scale 1 (best performance) to 3 (worst performance)
  measure: Change from baseline hopping quality (using dominant leg) at 6 months
  time frame: visit 7; six months post enrollment
  description: Quality performance on the hopping three times (using dominant leg) and land on the same limb as far as possible will be scored based on the distance hopped, measured at the level of the great toe on a range of scale 1 (best performance) to 3 (worst performance)
  measure: Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 4 weeks
  time frame: visit 6; one month post enrollment
  description: A markerless motion system will be used. Cameras will be used to collect the backward-forward displacement during 20 sec of static standing on both legs will be analyzed for ability to control static balance.
  measure: Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 6 months
  time frame: visit 7; six months post enrollment
  description: A markerless motion system will be used. Cameras will be used to collect the backward-forward displacement during 20 sec of static standing on both legs will be analyzed for ability to control static balance.
  measure: Change from baseline gait speed at 4 weeks
  time frame: visit 6; one month post enrollment
  description: Spatiotemporal parameters are analyzed [i.e. gait speed (meters/sec), cadence (steps/minute)]
  measure: Change from baseline gait speed at 6 months
  time frame: visit 7; six months post enrollment
  description: Spatiotemporal parameters are analyzed [i.e. gait speed (meters/sec), cadence (steps/minute)]
  measure: Change from baseline displacement of the center of gravity in vertical direction at 4 weeks
  time frame: visit 6; one month post enrollment
  description: Spatiotemporal parameters are analyzed (i.e. center of gravity vertical displacement measured in centimeters)
  measure: Change from baseline displacement of the body in vertical direction at 6 months
  time frame: visit 7; six months post enrollment
  description: Spatiotemporal parameters are analyzed (i.e. center of gravity vertical displacement measured in centimeters)
  measure: Change from baseline displacement between strides at 4 weeks
  time frame: visit 6; one month post enrollment
  description: Spatiotemporal parameters are analyzed (i.e. stride width measured in centimeters)
  measure: Change from baseline displacement between strides at 6 months
  time frame: visit 7; six months post enrollment
  description: Spatiotemporal parameters are analyzed (i.e. stride width measured in centimeters)
  arm group label: paper-based standard care exercise program
  arm group type: No Intervention
  arm group label: VPT
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: VPT
  description: The VPT will be comprised of weekly virtual visits with the participant for one month. During the visits, the physical therapist will review the exercises that were prescribed, adherence, provide feedback to the participant as they execute the exercises onscreen and make corrections, make any progression or adjustments to the exercises, review running cues they learned from the testing session and answer any questions. The therapist will also review any new activities that are initiated during the previous week (to control for confounders), changes in musculoskeletal pain and participation in running volume.
  arm group label: VPT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sharareh Sharififar, PhD, PT
  role: Principal Investigator
  affiliation: University of Florida
  last name: Sharareh PhD, PT
  phone: 3522738453
  email: sharareh75@ufl.edu
  last name: Jamie Bolliong
  phone: 3522737412
  email: jamiekbolling@ufl.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No