<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/NCT04493645</url>
  </required_header>
  <id_info>
    <org_study_id>58500</org_study_id>
    <secondary_id>CDMRP-OR190060</secondary_id>
    <nct_id>NCT04493645</nct_id>
  </id_info>
  <brief_title>Ankle Instability Using Foot Intensive Rehabilitation</brief_title>
  <acronym>FIRE</acronym>
  <official_title>Optimizing Clinical Outcomes for Patients With Chronic Ankle Instability Using Foot Intensive Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Matthew Hoch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Naval Health Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Marine Corps Base Camp Pendleton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</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>
      The overall objective of this study is to examine the effects of a 6-week foot-intensive&#xD;
      rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms,&#xD;
      sensorimotor function, and self-reported disability in CAI patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lateral ankle sprains are one of the most common injuries sustained by the general population&#xD;
      with the greatest rates in people who are physically active or service members. Approximately&#xD;
      40% of lateral ankle sprain patients develop chronic ankle instability (CAI) characterized by&#xD;
      recurrent lateral ankle sprains, repetitive sensations of ankle &quot;giving way&quot;, residual ankle&#xD;
      sprain symptoms, and self-reported disability. Factors related to the development and&#xD;
      progression of CAI has been thoroughly studied. However, few interventions have been&#xD;
      developed which have successfully created long term reductions in re-injury rates, physical&#xD;
      function, or health-related quality of life. Recent work by our research team has uncovered&#xD;
      several novel motor and sensory deficits in the foot in patients with CAI. Deficits in foot&#xD;
      function may contribute to the high re-injury rates, deficits in balance and strength, and&#xD;
      diminished health-related quality of life commonly experienced by individuals with CAI. The&#xD;
      investigators expect the additive effect of FIRE with components of the standard of care&#xD;
      (balance training, strength training, and range of motion) will create the synergy needed to&#xD;
      reduce future injuries (Aim 1), enhance physical function (Aim 2), and reduce self-reported&#xD;
      disability in CAI patients (Aim 3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 28, 2021</start_date>
  <completion_date type="Anticipated">October 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2024</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>The investigators will compare clinical and innovative outcome measures collected at five time points between cohorts of patients with CAI that receive a standard of care (SOC) rehabilitation program compared to an innovative foot intensive rehabilitation (FIRE) program to determine if FIRE can further reduce the rate of re-injury, improve sensorimotor function, and reduce self-reported disability during the 24 months following the intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The investigators collecting the outcomes will be blinded to group allocation. Separate investigators will be used for intervention delivery and outcomes assessment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of recurrent ankle sprains</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to attenuate the occurrence of ankle sprains compared to SOC rehabilitation will be determined through self-report. An ankle sprain will be operationally defined as an incident in which the rearfoot was inverted or supinated and resulted in a combination of swelling, pain, and time lost or modification of normal function for at least one day.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of episodes of the ankle giving way</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to attenuate the number of episodes of the ankle giving way compared to SOC rehabilitation will be determined through self-reported occurrences per week in the past month. Episodes of giving way will be operationally defined for the subject as an incident in which the rearfoot suddenly rolled, felt weak, or lost stability; however, the individual did not sustain an ankle sprain and was able to continue with normal function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of chronic ankle instability related symptoms</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to attenuate the severity of related symptoms compared to SOC rehabilitation will be determined through the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a 9-item instrument used to identify self-reported impairments associated with CAI. This instrument is scored on a 0-30 scale, where lower scores represent greater severity of CAI related symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postural Control</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to improve static and dynamic postural control compared to SOC rehabilitation will be determined. Multiple measurements will be made including: Single-limb stance on each limb with eyes open and eyes closed with use of a force plate for center of pressure measurements, Star Excursion Balance Test, forward jump single limb landing stabilization task. All measurements will be monitored while the participant wears an inertial sensor placed on the lumbar spine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle/Toe Strength</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to improve strength compared to SOC rehabilitation will be determined. Strength of the muscles surrounding the ankle and the toes will be assessed through a series of assessments with a digital handheld dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intrinsic Foot Muscle Activation</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to improve foot muscle activation compared to SOC rehabilitation will be determined. Abductor hallucis, flexor digitorum brevis, quadratus plantae, and flexor hallucis brevis functional activity ratios will be captured using diagnostic ultrasound with a 12-4 MHz linear array transducer probe and measured using Image J software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plantar Cutaneous Sensation</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to improve plantar cutaneous sensation compared to SOC rehabilitation will be determined. Plantar cutaneous sensation will be tested using a 20-piece Semmes-Weinstein Monofilament kit which has monofilaments ranging from to 0.008g of force (1.65 level) to 300g of force (6.65 level). Light touch detection thresholds will be assessed on the plantar surface at the 1st metatarsal head.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-Reported Ankle Function</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Foot and Ankle Ability Measure (FAAM). Sports and activities of daily living subscale scores will be calculated.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-Reported Disability</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Disablement in the Physically Active Scale (DPA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-Reported Fear Avoidance Beliefs</measure>
    <time_frame>24 months</time_frame>
    <description>The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Fear Avoidance Beliefs Questionnaire.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Ankle Injuries</condition>
  <condition>Ankle Sprains</condition>
  <arm_group>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to receive standard of care rehabilitation (SOC) for a period of 6 weeks.The investigators will prospectively follow participants assigned to the SOC group for 24 months following completion of their assigned SOC intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Foot Intensive Rehabilitation (FIRE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive foot intensive rehabilitation (FIRE) for a period of 6 weeks.The investigators will prospectively follow participants assigned to the FIRE group for 24 months following completion of their assigned SOC intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care Rehabilitation (SOC)</intervention_name>
    <description>6 weeks of standard of care rehabilitation will be given designed to restore ankle joint range of motion, strength, postural control, and functional movement. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.</description>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Foot Intensive Rehabilitation (FIRE)</intervention_name>
    <description>6 weeks of FIRE will be given along with elements of SOC. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.</description>
    <arm_group_label>Foot Intensive Rehabilitation (FIRE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18-44.&#xD;
&#xD;
          2. Previous history of at least 1 ankle sprain and at least 2 episodes of &quot;giving way&quot; in&#xD;
             the past 3 months.&#xD;
&#xD;
          3. Participants must answer &quot;yes&quot; to at least 5 questions on the Ankle Instability&#xD;
             Instrument.&#xD;
&#xD;
          4. Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI).&#xD;
&#xD;
          5. Confirmed clinical presentation of CAI by a PT, AT, or MD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sustained an ankle sprain in the previous four weeks or lower extremity&#xD;
             neuromusculoskeletal injury other than to the ankle in the last 12 months.&#xD;
&#xD;
          2. History of surgery to the lower extremity.&#xD;
&#xD;
          3. Sustained a lower extremity fracture.&#xD;
&#xD;
          4. History of neurological disease, vestibular or visual disturbance or any other&#xD;
             pathology that would impair their sensorimotor performance.&#xD;
&#xD;
          5. Current participation in a formal ankle joint rehabilitation program.&#xD;
&#xD;
          6. Sustained a concussion in the last 12 months.&#xD;
&#xD;
          7. Exhibit clinical examination characteristics of foot and ankle function which are&#xD;
             consistent with conditions other than CAI (i.e. fracture, deformity).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Hoch, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Douglas Long, M.S.</last_name>
    <phone>859-323-5438</phone>
    <email>delong2@uky.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthew Hoch, Ph.D.</last_name>
    <phone>859-323-9850</phone>
    <email>matt.hoch@uky.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536-0200</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Douglas Long, M.S.</last_name>
      <phone>859-323-5438</phone>
      <email>delong2@uky.edu</email>
    </contact>
    <contact_backup>
      <last_name>Matt Hoch, Ph.D.</last_name>
      <phone>859-323-9850</phone>
      <email>matt.hoch@uky.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Matthew Hoch</investigator_full_name>
    <investigator_title>Associate Professor, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>chronic ankle instability</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ankle Injuries</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/NCT04493645
org study id: 58500
secondary id: CDMRP-OR190060
nct id: NCT04493645
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of this study is to examine the effects of a 6-week foot-intensive
      rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms,
      sensorimotor function, and self-reported disability in CAI patients.
Lateral ankle sprains are one of the most common injuries sustained by the general population
      with the greatest rates in people who are physically active or service members. Approximately
      40% of lateral ankle sprain patients develop chronic ankle instability (CAI) characterized by
      recurrent lateral ankle sprains, repetitive sensations of ankle "giving way", residual ankle
      sprain symptoms, and self-reported disability. Factors related to the development and
      progression of CAI has been thoroughly studied. However, few interventions have been
      developed which have successfully created long term reductions in re-injury rates, physical
      function, or health-related quality of life. Recent work by our research team has uncovered
      several novel motor and sensory deficits in the foot in patients with CAI. Deficits in foot
      function may contribute to the high re-injury rates, deficits in balance and strength, and
      diminished health-related quality of life commonly experienced by individuals with CAI. The
      investigators expect the additive effect of FIRE with components of the standard of care
      (balance training, strength training, and range of motion) will create the synergy needed to
      reduce future injuries (Aim 1), enhance physical function (Aim 2), and reduce self-reported
      disability in CAI patients (Aim 3).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will compare clinical and innovative outcome measures collected at five time points between cohorts of patients with CAI that receive a standard of care (SOC) rehabilitation program compared to an innovative foot intensive rehabilitation (FIRE) program to determine if FIRE can further reduce the rate of re-injury, improve sensorimotor function, and reduce self-reported disability during the 24 months following the intervention.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The investigators collecting the outcomes will be blinded to group allocation. Separate investigators will be used for intervention delivery and outcomes assessment.
measure: Number of recurrent ankle sprains
time frame: 24 months
description: The ability of FIRE to attenuate the occurrence of ankle sprains compared to SOC rehabilitation will be determined through self-report. An ankle sprain will be operationally defined as an incident in which the rearfoot was inverted or supinated and resulted in a combination of swelling, pain, and time lost or modification of normal function for at least one day.
measure: Frequency of episodes of the ankle giving way
time frame: 24 months
description: The ability of FIRE to attenuate the number of episodes of the ankle giving way compared to SOC rehabilitation will be determined through self-reported occurrences per week in the past month. Episodes of giving way will be operationally defined for the subject as an incident in which the rearfoot suddenly rolled, felt weak, or lost stability; however, the individual did not sustain an ankle sprain and was able to continue with normal function.
measure: Severity of chronic ankle instability related symptoms
time frame: 24 months
description: The ability of FIRE to attenuate the severity of related symptoms compared to SOC rehabilitation will be determined through the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a 9-item instrument used to identify self-reported impairments associated with CAI. This instrument is scored on a 0-30 scale, where lower scores represent greater severity of CAI related symptoms.
measure: Postural Control
time frame: 24 months
description: The ability of FIRE to improve static and dynamic postural control compared to SOC rehabilitation will be determined. Multiple measurements will be made including: Single-limb stance on each limb with eyes open and eyes closed with use of a force plate for center of pressure measurements, Star Excursion Balance Test, forward jump single limb landing stabilization task. All measurements will be monitored while the participant wears an inertial sensor placed on the lumbar spine.
measure: Ankle/Toe Strength
time frame: 24 months
description: The ability of FIRE to improve strength compared to SOC rehabilitation will be determined. Strength of the muscles surrounding the ankle and the toes will be assessed through a series of assessments with a digital handheld dynamometer.
measure: Intrinsic Foot Muscle Activation
time frame: 24 months
description: The ability of FIRE to improve foot muscle activation compared to SOC rehabilitation will be determined. Abductor hallucis, flexor digitorum brevis, quadratus plantae, and flexor hallucis brevis functional activity ratios will be captured using diagnostic ultrasound with a 12-4 MHz linear array transducer probe and measured using Image J software.
measure: Plantar Cutaneous Sensation
time frame: 24 months
description: The ability of FIRE to improve plantar cutaneous sensation compared to SOC rehabilitation will be determined. Plantar cutaneous sensation will be tested using a 20-piece Semmes-Weinstein Monofilament kit which has monofilaments ranging from to 0.008g of force (1.65 level) to 300g of force (6.65 level). Light touch detection thresholds will be assessed on the plantar surface at the 1st metatarsal head.
measure: Self-Reported Ankle Function
time frame: 24 months
description: The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Foot and Ankle Ability Measure (FAAM). Sports and activities of daily living subscale scores will be calculated.
measure: Self-Reported Disability
time frame: 24 months
description: The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Disablement in the Physically Active Scale (DPA).
measure: Self-Reported Fear Avoidance Beliefs
time frame: 24 months
description: The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Fear Avoidance Beliefs Questionnaire.
arm group label: Standard of Care (SOC)
arm group type: Active Comparator
description: Participants will be randomized to receive standard of care rehabilitation (SOC) for a period of 6 weeks.The investigators will prospectively follow participants assigned to the SOC group for 24 months following completion of their assigned SOC intervention.
arm group label: Foot Intensive Rehabilitation (FIRE)
arm group type: Experimental
description: Participants will be randomized to receive foot intensive rehabilitation (FIRE) for a period of 6 weeks.The investigators will prospectively follow participants assigned to the FIRE group for 24 months following completion of their assigned SOC intervention.
intervention type: Behavioral
intervention name: Standard of Care Rehabilitation (SOC)
description: 6 weeks of standard of care rehabilitation will be given designed to restore ankle joint range of motion, strength, postural control, and functional movement. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.
arm group label: Standard of Care (SOC)
intervention type: Behavioral
intervention name: Foot Intensive Rehabilitation (FIRE)
description: 6 weeks of FIRE will be given along with elements of SOC. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.
arm group label: Foot Intensive Rehabilitation (FIRE)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
last name: Matthew Hoch, Ph.D.
role: Principal Investigator
affiliation: University of Kentucky
last name: Douglas Long, M.S.
phone: 859-323-5438
email: delong2@uky.edu
last name: Matthew Hoch, Ph.D.
phone: 859-323-9850
email: matt.hoch@uky.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Matthew Hoch
investigator title: Associate Professor, Principal Investigator
mesh term: Ankle Injuries
sharing ipd: No