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/NCT05968729</url>
    </required_header>
    <id_info>
      <org_study_id>H21-0176</org_study_id>
      <secondary_id>K01AR079043</secondary_id>
      <nct_id>NCT05968729</nct_id>
    </id_info>
    <brief_title>Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol</brief_title>
    <official_title>Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Connecticut</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Connecticut</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 purpose of this work is to conduct a comparative research-focused study to evaluate the&#xD;
        effectiveness of how purposefully induced asymmetric walking protocols restore healthy,&#xD;
        symmetric limb loading in individuals following post-anterior cruciate ligament&#xD;
        reconstruction (ACLR) surgery. Additionally, computational modeling and machine learning to&#xD;
        model knee loading in the clinic to determine the optimal asymmetric walking protocol to&#xD;
        restore healthy gait in post-ACLR individuals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an intervention study in which participants will be randomized as to the order in&#xD;
        which each of the two sessions are completed. Forty post-ACLR will who present with&#xD;
        between-limb gait differences will perform two asymmetric walking sessions where they will&#xD;
        walk with between-limb gait speed differences of 0.25 m/s and 0.50 m/s at three 15-minute&#xD;
        intervals to evaluate the restoration of healthy gait. Post-ACLR participants will perform an&#xD;
        asymmetric walking intervention protocol session on two different days. On one day they will&#xD;
        perform the protocol with a 0.25 m/s between-limb difference and on a separate day they will&#xD;
        perform the protocol with a 0.50 m/s between limb difference. For the 0.25 m/s condition, one&#xD;
        limb will be set to 1.0 m/s and the other 1.25 m/s (i.e., 1.0 m/s - 1.25 m/s). Similarly, for&#xD;
        the 0.50 m/s condition, one limb will be set to 1.0 m/s and the other 1.50 m/s (i.e., 1.0 m/s&#xD;
        - 1.50 m/s). Each participant will perform both the 0.25 m/s and 0.50 m/s protocols on&#xD;
        separate days, and we will randomize who performs which protocol first or second. At least 3&#xD;
        weeks must pass between the two one-day sessions. Patient-specific simulations will be&#xD;
        generated in OpenSim for each of the 40 post-ACLR individuals to assess differences in knee&#xD;
        joint loading. Together with machine learning, these models will help evaluate the&#xD;
        effectiveness of the asymmetric walking protocol in reducing detrimental knee loading. The&#xD;
        study team hypothesizes that the 0.50 m/s perturbation will produce a larger reduction in&#xD;
        between-limb asymmetry than the 0.25 m/s perturbation and reduce detrimental knee loading.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Anticipated">July 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2027</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>Crossover Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Loading Rate</measure>
      <time_frame>Screening, Baseline, and Post-Treatment (immediately following the completion of the second session)</time_frame>
      <description>The rate at which the force is generated (Body Weight/sec). A decrease in loading rate would suggest that the participants adopted improved motor control while an increase would reflect impaired of motor control.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Peak Vertical Ground Reaction Force</measure>
      <time_frame>Baseline, Post-Treatment (immediately following the completion of the second session)</time_frame>
      <description>The largest force (newtons) produced during stance. An increase in force would that the participants are not properly engaging their muscles to control their movement.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Stride Time</measure>
      <time_frame>Baseline, Post-Treatment (immediately following the completion of the second session)</time_frame>
      <description>The time (seconds) measure from initial contact on the foot to the next initial contact on the same foot. A reduction in stride time would indicate that the participants are walking faster and more comfortable applying force to their limb during walking. An increase in walking speed, suggests that the participants are uncomfortable applying force to their limb.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Knee Loading</measure>
      <time_frame>Baseline, Post-Treatment (immediately following the completion of the second session)</time_frame>
      <description>The forces (newtons) experienced at the knee. An increase in knee loading would indicate that they participants are unable to properly support their knee during walking, while a reduction in knee loads would indicate the participants are engaging the appropriate muscles to support their knee during walking.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Anterior Cruciate Ligament Reconstruction</condition>
    <arm_group>
      <arm_group_label>0.25 m/s asymmetric session first</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will perform three 15-minute sessions of walking with a 0.25 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.25 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0.50 m/s asymmetric walking session first</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will perform three 15-minute sessions of walking with a 0.50 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.5 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Active Comparator: 0.25 m/s asymmetric session first</intervention_name>
      <description>Participants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s.</description>
      <arm_group_label>0.25 m/s asymmetric session first</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Active Comparator: 0.50 m/s asymmetric session first</intervention_name>
      <description>Participants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s.</description>
      <arm_group_label>0.50 m/s asymmetric walking session first</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Able to read and speak English&#xD;
  &#xD;
            2. Age 18 - 30 years old&#xD;
  &#xD;
            3. Undergone ACLR surgery at the UConn Musculoskeletal Institute&#xD;
  &#xD;
            4. Must not have any concomitant surgeries or injuries&#xD;
  &#xD;
            5. Must be cleared to return-to-sport by a physician after they have completed&#xD;
               rehabilitation&#xD;
  &#xD;
            6. Must be within 1 month of having been cleared for return-to-sport&#xD;
  &#xD;
            7. Must present with between-limb gait differences in load rate greater than 10%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants who have any recent inflammation, bleeding disorders, active bleeding, or&#xD;
               infection within the lower limbs.&#xD;
  &#xD;
            2. History of injuries to their patellar tendon&#xD;
  &#xD;
            3. Cannot walk for extended periods of time&#xD;
  &#xD;
            4. Cannot have had any back and/or lower extremity injury that affects their ability to&#xD;
               move.&#xD;
  &#xD;
            5. Cannot have difficulty or pain with walking, raising your arms, jogging, or jumping&#xD;
  &#xD;
            6. Must not be allergic to tape.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kristin Morgan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Connecticut</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristin Morgan, PhD</last_name>
      <phone>860-486-8118</phone>
      <email>kristin.2.morgan@uconn.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Noah Davidson, BS</last_name>
      <phone>860-486-8118</phone>
      <email>noah.davidson@uconn.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Connecticut</name>
        <address>
          <city>Storrs</city>
          <state>Connecticut</state>
          <zip>06269</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kristin Morgan, PhD</last_name>
        <phone>860-486-8118</phone>
        <email>kristin.2.morgan@uconn.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Connecticut</investigator_affiliation>
      <investigator_full_name>Kristin Morgan</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </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/NCT05968729
  org study id: H21-0176
  secondary id: K01AR079043
  nct id: NCT05968729
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this work is to conduct a comparative research-focused study to evaluate the
        effectiveness of how purposefully induced asymmetric walking protocols restore healthy,
        symmetric limb loading in individuals following post-anterior cruciate ligament
        reconstruction (ACLR) surgery. Additionally, computational modeling and machine learning to
        model knee loading in the clinic to determine the optimal asymmetric walking protocol to
        restore healthy gait in post-ACLR individuals.
  This is an intervention study in which participants will be randomized as to the order in
        which each of the two sessions are completed. Forty post-ACLR will who present with
        between-limb gait differences will perform two asymmetric walking sessions where they will
        walk with between-limb gait speed differences of 0.25 m/s and 0.50 m/s at three 15-minute
        intervals to evaluate the restoration of healthy gait. Post-ACLR participants will perform an
        asymmetric walking intervention protocol session on two different days. On one day they will
        perform the protocol with a 0.25 m/s between-limb difference and on a separate day they will
        perform the protocol with a 0.50 m/s between limb difference. For the 0.25 m/s condition, one
        limb will be set to 1.0 m/s and the other 1.25 m/s (i.e., 1.0 m/s - 1.25 m/s). Similarly, for
        the 0.50 m/s condition, one limb will be set to 1.0 m/s and the other 1.50 m/s (i.e., 1.0 m/s
        - 1.50 m/s). Each participant will perform both the 0.25 m/s and 0.50 m/s protocols on
        separate days, and we will randomize who performs which protocol first or second. At least 3
        weeks must pass between the two one-day sessions. Patient-specific simulations will be
        generated in OpenSim for each of the 40 post-ACLR individuals to assess differences in knee
        joint loading. Together with machine learning, these models will help evaluate the
        effectiveness of the asymmetric walking protocol in reducing detrimental knee loading. The
        study team hypothesizes that the 0.50 m/s perturbation will produce a larger reduction in
        between-limb asymmetry than the 0.25 m/s perturbation and reduce detrimental knee loading.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: Change in Loading Rate
  time frame: Screening, Baseline, and Post-Treatment (immediately following the completion of the second session)
  description: The rate at which the force is generated (Body Weight/sec). A decrease in loading rate would suggest that the participants adopted improved motor control while an increase would reflect impaired of motor control.
  measure: Change in Peak Vertical Ground Reaction Force
  time frame: Baseline, Post-Treatment (immediately following the completion of the second session)
  description: The largest force (newtons) produced during stance. An increase in force would that the participants are not properly engaging their muscles to control their movement.
  measure: Change in Stride Time
  time frame: Baseline, Post-Treatment (immediately following the completion of the second session)
  description: The time (seconds) measure from initial contact on the foot to the next initial contact on the same foot. A reduction in stride time would indicate that the participants are walking faster and more comfortable applying force to their limb during walking. An increase in walking speed, suggests that the participants are uncomfortable applying force to their limb.
  measure: Change in Knee Loading
  time frame: Baseline, Post-Treatment (immediately following the completion of the second session)
  description: The forces (newtons) experienced at the knee. An increase in knee loading would indicate that they participants are unable to properly support their knee during walking, while a reduction in knee loads would indicate the participants are engaging the appropriate muscles to support their knee during walking.
  arm group label: 0.25 m/s asymmetric session first
  arm group type: Active Comparator
  description: Participants will perform three 15-minute sessions of walking with a 0.25 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.25 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s.
  arm group label: 0.50 m/s asymmetric walking session first
  arm group type: Active Comparator
  description: Participants will perform three 15-minute sessions of walking with a 0.50 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.5 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s.
  intervention type: Other
  intervention name: Active Comparator: 0.25 m/s asymmetric session first
  description: Participants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s.
  arm group label: 0.25 m/s asymmetric session first
  intervention type: Other
  intervention name: Active Comparator: 0.50 m/s asymmetric session first
  description: Participants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s.
  arm group label: 0.50 m/s asymmetric walking session first
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: No
  last name: Kristin Morgan, PhD
  role: Principal Investigator
  affiliation: University of Connecticut
  last name: Kristin Morgan, PhD
  phone: 860-486-8118
  email: kristin.2.morgan@uconn.edu
  last name: Noah Davidson, BS
  phone: 860-486-8118
  email: noah.davidson@uconn.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Connecticut
  investigator full name: Kristin Morgan
  investigator title: Assistant Professor
  sharing ipd: No