<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/NCT02987517</url>
  </required_header>
  <id_info>
    <org_study_id>2015P000724</org_study_id>
    <nct_id>NCT02987517</nct_id>
  </id_info>
  <brief_title>A Comparative Effectiveness Study of Two Interventions Aimed at Reducing Impact Loads in Runners</brief_title>
  <official_title>A Prospective Study of Interventions Aimed at Reducing Impact Loads in Runners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spaulding Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will use a comparative effectiveness design of two interventions known to reduce&#xD;
      running impacts. The study will be conducted at the Spaulding National Running Center. A&#xD;
      total of 40 male and female participants, between ages 18-50 years, running 10- 30 miles per&#xD;
      week will be recruited from the local running community. All potential subjects will be&#xD;
      cleared for physical activity using a Physical Activity Readiness Questionnaire (PAR-Q) and&#xD;
      screened via high-speed video to determine their habitual footstrike pattern. Those who are&#xD;
      rearfoot strikers will be included and will then be randomized to either an increased cadence&#xD;
      (CAD) or a forefoot strike (FFS) intervention group. Standardized running shoes will be&#xD;
      provided to both groups for the duration of the study. All participants will attend 2&#xD;
      strength-training instruction sessions with a physical therapist prior to gait-retraining&#xD;
      intervention. They will be instructed to perform the learned exercises daily for 4 weeks to&#xD;
      prepare the body tissues for forces associated with new gait methods. Subjects will then&#xD;
      attend 8 gait-retraining sessions over 2-3 weeks. Sessions will be scheduled as two&#xD;
      sequential days of training followed by a day of rest. The gait retraining protocols will be&#xD;
      conducted on a treadmill. 3D Motion Capture analysis will be conducted at baseline and at 3&#xD;
      points following intervention (1 week, 1 month, and 6 months).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SUBJECT ENROLLMENT&#xD;
&#xD;
      When potential participants are contacted (or contact investigators), they will be screened&#xD;
      by phone or email to ensure they meet the study inclusion or exclusion criteria. If they do,&#xD;
      details of the study procedures will be explained and they will be given the opportunity to&#xD;
      ask questions and take as much time as required to decide if they would like to participate.&#xD;
      In addition, once consent is obtained, subjects will undergo an initial screening treadmill&#xD;
      run to ensure foot strike and cadence inclusion criteria are met.&#xD;
&#xD;
      Before the study begins, participants will be provided with a written consent form and be&#xD;
      given the opportunity to ask any further questions. Prior to initiation of initial screening,&#xD;
      data collection, or treatment, participants must sign the consent form.&#xD;
&#xD;
      Participants will be randomly assigned via computer to one of two treatment conditions: 1)&#xD;
      increased cadence running gait or 2) forefoot strike running gait.&#xD;
&#xD;
      STUDY PROCEDURES&#xD;
&#xD;
      Subjects will have 13 visits to the Spaulding National Running Center for screening,&#xD;
      interventions, and biomechanical analyses. Each visit is outlined below: Visit 1 (2.5 hours)&#xD;
      determine if subject uses habitual heel strike and cadence less than or equal to 170, color&#xD;
      vision test measure subject's weight, height, leg length, and arch height Baseline&#xD;
      biomechanical analysis on instrumented treadmill Physical therapist-researcher will instruct&#xD;
      strengthening exercises for feet and legs Subjects told to perform exercises daily and keep&#xD;
      journal for 4 weeks&#xD;
&#xD;
      Visit 2 (30 minutes) One week after exercise instruction, subjects meet with a&#xD;
      physical-therapist researcher to review and perform strengthening exercises and voice any&#xD;
      questions or concerns&#xD;
&#xD;
      Visits 3-10 (1 hour each) Gait retraining on a treadmill using auditory feedback (metronome&#xD;
      for cadence or Noraxon system for forefoot strike) and verbal instruction from a physical&#xD;
      therapist.&#xD;
&#xD;
      These visits will be distributed over a 2-3 week time period. Subjects may run 2 days in a&#xD;
      row, but never 3 days in a row.&#xD;
&#xD;
      Visit 11 (1 week after final gait retraining) (2 hours) Measure subject's resting heart rate,&#xD;
      weight, height, leg length, and arch height Biomechanical analysis of running gait on&#xD;
      instrumented treadmill Biomechanical analysis of running gait on instrumented treadmill until&#xD;
      either 85-90 percent of age predicted heart rate is reached or a Borg Rating of Perceived&#xD;
      Exertion score of greater than or equal to 17 is reached.&#xD;
&#xD;
      Subjects instructed in use of REDCap secure web application for journal of running frequency&#xD;
      and distance (in miles), any discomfort or injuries that occur with running over the next 6&#xD;
      months.&#xD;
&#xD;
      Visit 12 (1 month after final gait retraining) (2 hours)&#xD;
&#xD;
      Measure subject's weight, height, leg length, and arch height Biomechanical analysis on&#xD;
      instrumented treadmill Remind subjects to continue to keep journal&#xD;
&#xD;
      Reminder via email or phone call Physical therapist-researcher will contact subjects 1 time&#xD;
      per month over the next 5 months to remind them to continue keeping journal of running&#xD;
      frequency and distance (in miles), and any discomfort or injuries that occur.&#xD;
&#xD;
      Visit 13 (6 months after final gait retraining) (2 hours) Measure subject's weight, height,&#xD;
      leg length, and arch height Biomechanical analysis on instrumented treadmill&#xD;
&#xD;
      The outcomes to be measured may include any combination of the following:&#xD;
&#xD;
      Structural measures: Height, weight, leg length, arch height. Video analysis: Digital video&#xD;
      will only record the waist and below. Motion analysis: recording 3 dimensional movements&#xD;
      using a computerized system with reflective markers attached to the body and high-speed&#xD;
      cameras.&#xD;
&#xD;
      Ground reaction forces: gathered through force sensing platforms embedded in the treadmill&#xD;
      Impact: an accelerometer attached to the body to record the impact experienced by the body&#xD;
      with each footstrike.&#xD;
&#xD;
      Devices to be used The data will be collected using 3D motion capture (Vicon Motion Systems)&#xD;
      in conjunction with 2 force plates (AMTI), which are embedded in the treadmill. Other devices&#xD;
      to be used are foot calipers for arch height, a digital metronome, and an accelerometer with&#xD;
      auditory feedback (Noraxon). These are all minimally invasive procedures that involve&#xD;
      attaching sensors or markers to the skin and recording the output from the sensor.&#xD;
&#xD;
      d) Procedures/interventions All study procedures will take place at the Spaulding National&#xD;
      Running Center in the Instrumented Treadmill Lab and clinic. Biomechanical Analysis&#xD;
&#xD;
      All biomechanical analyses of running gait will take place in the Treadmill Lab using an&#xD;
      instrumented treadmill (AMTI) and a 3D motion analysis system. Four biomechanical analyses&#xD;
      will be conducted over the duration of this investigation. These will occur at baseline, 1&#xD;
      week after the final gait retraining session, 1 month following gait retraining, and 6 months&#xD;
      following gait retraining. Procedures for each analysis are as follows:&#xD;
&#xD;
      Subjects will run for a 3 minute warm up and be allowed to adjust to a speed of their&#xD;
      preference. An investigator will control treadmill speed, but both participant and&#xD;
      investigator can stop the treadmill at anytime via the emergency stop buttons. After warm up,&#xD;
      data collection will occur for 4000 frames (15-20 steps). To minimize or prevent any&#xD;
      laboratory performance effects, subjects will be distracted during data recording. The&#xD;
      distraction technique is based on the Stroop Color and Word Test, and involves subjects&#xD;
      reading aloud words on a screen directly in front of the treadmill. The correctness of the&#xD;
      test is of no interest; rather, it only serves as a distraction technique.&#xD;
&#xD;
      Fatigue run One week after the final gait retraining session, subjects will be asked to run&#xD;
      until they feel fatigued. Fatigue will be defined as either of the following two criteria:&#xD;
      when the subject reaches 85-90 percent of age predicted heart rate max or when they report a&#xD;
      score greater than or equal to 17 on the Borg Rating of Perceived Exertion scale. Once&#xD;
      fatigue is reached, data will be collected for 4000 frames (15-20 steps).&#xD;
&#xD;
      Strengthening exercises During the first visit, a physical-therapist investigator will&#xD;
      instruct subjects in strengthening exercises for the feet and legs. These activities will&#xD;
      prepare musculoskeletal tissues to adapt to new forces they will experience during gait&#xD;
      retraining. Subjects will be instructed to perform the exercises daily for 4 weeks, and will&#xD;
      be given a journal to record their exercise performance. One week after exercise instruction,&#xD;
      subjects will meet with the physical therapist-investigator to review the strengthening&#xD;
      exercises and report any questions or concerns.&#xD;
&#xD;
      Gait Retraining&#xD;
&#xD;
      There will be 8 gait-retraining sessions over a 2-3 week time period. Subjects will be&#xD;
      randomly assigned to either an increased cadence gait or a forefoot strike gait. The gait&#xD;
      retraining protocols will be conducted on a treadmill (Woodway) in the clinic of the&#xD;
      Spaulding National Running Center in the following manner:&#xD;
&#xD;
      Increased cadence (CAD) Protocol: After a 3-minute warm up, subjects' preferred step rate&#xD;
      will be determined during their self-selected moderate intensity run for an additional 3&#xD;
      minutes using a visual count of footstrikes. Subjects will then be asked to increase their&#xD;
      normal cadence by 7.5 percent while maintaining their speed. This will be accomplished by&#xD;
      having subjects match their footstrikes to the beat of an audible digital metronome.&#xD;
&#xD;
      Forefoot strike (FFS) Protocol: Subjects will wear an accelerometer on the right anterior&#xD;
      distal tibial. After a 3-minute warm up run, subjects will continue running for an additional&#xD;
      3 minutes and a baseline rearfoot strike accelerometer value will be recorded. Next, subjects&#xD;
      will be instructed to land gently on the ball of their foot and lower their heels to the&#xD;
      ground. They will be guided with verbal cues and visual inspection from a physical therapist.&#xD;
      A forefoot strike accelerometer value will be recorded. If this value is exceeded, the device&#xD;
      will provide audible feedback when a heel strike is detected signaling the runner to land&#xD;
      with a FFS pattern.&#xD;
&#xD;
      For both groups, run time will be gradually increased from 10-30 minutes over 8 sessions. The&#xD;
      auditory feedback will be provided constantly for the first 4 sessions and then gradually&#xD;
      decreased in a systematic manner for the last four sessions. This feedback schedule has&#xD;
      produced successful outcomes in a number of gait retraining studies.4,5,6 The feedback&#xD;
      schedule for both groups is detailed as follows:&#xD;
&#xD;
      Session 1 - 10 minute treadmill run with metronome auditory feedback 100 percent of the time&#xD;
&#xD;
      Sessions 2,3,4 - Time of run will be gradually increased over sessions 2,3,4 to 12, 15, and&#xD;
      18 minutes respectively. Auditory feedback 100 percent of the time.&#xD;
&#xD;
      Sessions 5,6,7,8 - Time of run will be gradually increased over sessions 5,6,7,8 to 21,24,27,&#xD;
      and 30 minutes respectively. Auditory feedback will be gradually reduced and given only at&#xD;
      the beginning, middle, and end of a run.&#xD;
&#xD;
      This will be 4 minutes for sessions 5; 3 minutes for session 6; 2 minutes for session 7; and&#xD;
      1 minute for session 8.&#xD;
&#xD;
      Participants will be instructed not to run at any other time outside of the gait-retraining&#xD;
      period. After completion of gait retraining, subjects will be encouraged to continue their&#xD;
      new gait pattern as they run independently in the community. They will be instructed to&#xD;
      increase running distance by no greater than 10 percent per week until they reach their&#xD;
      desired running duration or distance. Subjects will be asked to keep journals of running&#xD;
      activity after gait retraining until they return for the final gait analysis. This will be&#xD;
      done via the REDCap (Research Electronic Data Capture) secure web application.&#xD;
&#xD;
      Data to be collected and when the data is to be collected:&#xD;
&#xD;
      Biomechanical outcomes as described above will be collected during each of the 5&#xD;
      biomechanical analyses that participants attend at the Spaulding National Running Center.&#xD;
      Every effort will be made to accommodate participants' schedules for these sessions. Data&#xD;
      collection will occur at the first visit (baseline), 1 week following gait retraining&#xD;
      (approximately 7 to 8 weeks from baseline), 1 month after gait retraining (approximately 11&#xD;
      weeks from baseline), and 6 months after gait retraining (approximately 35 weeks from&#xD;
      baseline).&#xD;
&#xD;
      Journals of daily strengthening exercise performance will be collected at Visit 3 (4 weeks&#xD;
      from baseline). Journals of running frequency and distance and any discomfort or injuries&#xD;
      will be collected throughout the 6 month follow up period using REDCap secure web application&#xD;
      (9 to 35 weeks from baseline).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Vertical Load Rates</measure>
    <time_frame>baseline, 1 week follow up, 1 month follow up, 6 month follow up</time_frame>
    <description>average rate of loading calculated from Vertical Ground Reaction Force</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Foot Angle</measure>
    <time_frame>baseline, 1 week follow up, 1 month follow up, 6 month follow up</time_frame>
    <description>angle of foot in relation to ground, determines foot strike type</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in running cadence (steps per minute)</measure>
    <time_frame>baseline, 1 week follow up, 1 month follow up, 6 month follow up</time_frame>
    <description>number of steps taken per minute</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Musculoskeletal Injury</condition>
  <arm_group>
    <arm_group_label>Cadence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Runners who use an increased running cadence of 7.5 percent over preferred running cadence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Forefoot Strike</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Runners who use a forefoot strike instead of a rear foot strike</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Increased running cadence gait retraining</intervention_name>
    <description>Runners use an increased cadence, or step rate, 7.5% greater than baseline preferred cadence</description>
    <arm_group_label>Cadence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Forefoot Strike gait retraining</intervention_name>
    <description>Runners use a forefoot strike running gait instead of a rear foot strike running gait.</description>
    <arm_group_label>Forefoot Strike</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strengthening exercises</intervention_name>
    <description>foot and ankle strengthening exercises performed by all subjects to prepare musculoskeletal tissues for requirements of new running gait.</description>
    <arm_group_label>Cadence</arm_group_label>
    <arm_group_label>Forefoot Strike</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of running-related injury (outside of the past 3 months)&#xD;
&#xD;
          -  ages 18 to 50 years&#xD;
&#xD;
          -  currently running 5 to15 miles per week for at least 3 months&#xD;
&#xD;
          -  habitual running cadence of less than or equal to 170 steps/min&#xD;
&#xD;
          -  no contraindications for exercise as determined by the Physical Activity Readiness&#xD;
             Questionnaire (PAR-Q).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not use a heel strike as their habitual gait pattern&#xD;
&#xD;
          -  habitual cadence greater than 170 steps/min&#xD;
&#xD;
          -  history of injury within the past 3 months&#xD;
&#xD;
          -  any history of stress fracture to any bone of the foot or ankle&#xD;
&#xD;
          -  any past injuries or surgeries that have permanently altered gait&#xD;
&#xD;
          -  color blindness&#xD;
&#xD;
        Injury will be defined as:&#xD;
&#xD;
        Running-related (training or competition) musculoskeletal pain in the lower limbs that&#xD;
        causes a restriction on or stoppage of running (distance, speed, duration or training) for&#xD;
        at least seven days or three consecutive scheduled training sessions, or that requires the&#xD;
        runner to consult a physician or other health professional&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Davis, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Director, Spaulding National Running Center</affiliation>
  </overall_official>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spaulding Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Irene Sprague Davis</investigator_full_name>
    <investigator_title>Director, Spaulding National Running Center</investigator_title>
  </responsible_party>
  <keyword>running</keyword>
  <keyword>vertical load rates</keyword>
  <keyword>cadence</keyword>
  <keyword>footstrike</keyword>
  <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/NCT02987517
org study id: 2015P000724
nct id: NCT02987517
lead sponsor: 
has dmc: No
This study will use a comparative effectiveness design of two interventions known to reduce
      running impacts. The study will be conducted at the Spaulding National Running Center. A
      total of 40 male and female participants, between ages 18-50 years, running 10- 30 miles per
      week will be recruited from the local running community. All potential subjects will be
      cleared for physical activity using a Physical Activity Readiness Questionnaire (PAR-Q) and
      screened via high-speed video to determine their habitual footstrike pattern. Those who are
      rearfoot strikers will be included and will then be randomized to either an increased cadence
      (CAD) or a forefoot strike (FFS) intervention group. Standardized running shoes will be
      provided to both groups for the duration of the study. All participants will attend 2
      strength-training instruction sessions with a physical therapist prior to gait-retraining
      intervention. They will be instructed to perform the learned exercises daily for 4 weeks to
      prepare the body tissues for forces associated with new gait methods. Subjects will then
      attend 8 gait-retraining sessions over 2-3 weeks. Sessions will be scheduled as two
      sequential days of training followed by a day of rest. The gait retraining protocols will be
      conducted on a treadmill. 3D Motion Capture analysis will be conducted at baseline and at 3
      points following intervention (1 week, 1 month, and 6 months).
SUBJECT ENROLLMENT

      When potential participants are contacted (or contact investigators), they will be screened
      by phone or email to ensure they meet the study inclusion or exclusion criteria. If they do,
      details of the study procedures will be explained and they will be given the opportunity to
      ask questions and take as much time as required to decide if they would like to participate.
      In addition, once consent is obtained, subjects will undergo an initial screening treadmill
      run to ensure foot strike and cadence inclusion criteria are met.

      Before the study begins, participants will be provided with a written consent form and be
      given the opportunity to ask any further questions. Prior to initiation of initial screening,
      data collection, or treatment, participants must sign the consent form.

      Participants will be randomly assigned via computer to one of two treatment conditions: 1)
      increased cadence running gait or 2) forefoot strike running gait.

      STUDY PROCEDURES

      Subjects will have 13 visits to the Spaulding National Running Center for screening,
      interventions, and biomechanical analyses. Each visit is outlined below: Visit 1 (2.5 hours)
      determine if subject uses habitual heel strike and cadence less than or equal to 170, color
      vision test measure subject's weight, height, leg length, and arch height Baseline
      biomechanical analysis on instrumented treadmill Physical therapist-researcher will instruct
      strengthening exercises for feet and legs Subjects told to perform exercises daily and keep
      journal for 4 weeks

      Visit 2 (30 minutes) One week after exercise instruction, subjects meet with a
      physical-therapist researcher to review and perform strengthening exercises and voice any
      questions or concerns

      Visits 3-10 (1 hour each) Gait retraining on a treadmill using auditory feedback (metronome
      for cadence or Noraxon system for forefoot strike) and verbal instruction from a physical
      therapist.

      These visits will be distributed over a 2-3 week time period. Subjects may run 2 days in a
      row, but never 3 days in a row.

      Visit 11 (1 week after final gait retraining) (2 hours) Measure subject's resting heart rate,
      weight, height, leg length, and arch height Biomechanical analysis of running gait on
      instrumented treadmill Biomechanical analysis of running gait on instrumented treadmill until
      either 85-90 percent of age predicted heart rate is reached or a Borg Rating of Perceived
      Exertion score of greater than or equal to 17 is reached.

      Subjects instructed in use of REDCap secure web application for journal of running frequency
      and distance (in miles), any discomfort or injuries that occur with running over the next 6
      months.

      Visit 12 (1 month after final gait retraining) (2 hours)

      Measure subject's weight, height, leg length, and arch height Biomechanical analysis on
      instrumented treadmill Remind subjects to continue to keep journal

      Reminder via email or phone call Physical therapist-researcher will contact subjects 1 time
      per month over the next 5 months to remind them to continue keeping journal of running
      frequency and distance (in miles), and any discomfort or injuries that occur.

      Visit 13 (6 months after final gait retraining) (2 hours) Measure subject's weight, height,
      leg length, and arch height Biomechanical analysis on instrumented treadmill

      The outcomes to be measured may include any combination of the following:

      Structural measures: Height, weight, leg length, arch height. Video analysis: Digital video
      will only record the waist and below. Motion analysis: recording 3 dimensional movements
      using a computerized system with reflective markers attached to the body and high-speed
      cameras.

      Ground reaction forces: gathered through force sensing platforms embedded in the treadmill
      Impact: an accelerometer attached to the body to record the impact experienced by the body
      with each footstrike.

      Devices to be used The data will be collected using 3D motion capture (Vicon Motion Systems)
      in conjunction with 2 force plates (AMTI), which are embedded in the treadmill. Other devices
      to be used are foot calipers for arch height, a digital metronome, and an accelerometer with
      auditory feedback (Noraxon). These are all minimally invasive procedures that involve
      attaching sensors or markers to the skin and recording the output from the sensor.

      d) Procedures/interventions All study procedures will take place at the Spaulding National
      Running Center in the Instrumented Treadmill Lab and clinic. Biomechanical Analysis

      All biomechanical analyses of running gait will take place in the Treadmill Lab using an
      instrumented treadmill (AMTI) and a 3D motion analysis system. Four biomechanical analyses
      will be conducted over the duration of this investigation. These will occur at baseline, 1
      week after the final gait retraining session, 1 month following gait retraining, and 6 months
      following gait retraining. Procedures for each analysis are as follows:

      Subjects will run for a 3 minute warm up and be allowed to adjust to a speed of their
      preference. An investigator will control treadmill speed, but both participant and
      investigator can stop the treadmill at anytime via the emergency stop buttons. After warm up,
      data collection will occur for 4000 frames (15-20 steps). To minimize or prevent any
      laboratory performance effects, subjects will be distracted during data recording. The
      distraction technique is based on the Stroop Color and Word Test, and involves subjects
      reading aloud words on a screen directly in front of the treadmill. The correctness of the
      test is of no interest; rather, it only serves as a distraction technique.

      Fatigue run One week after the final gait retraining session, subjects will be asked to run
      until they feel fatigued. Fatigue will be defined as either of the following two criteria:
      when the subject reaches 85-90 percent of age predicted heart rate max or when they report a
      score greater than or equal to 17 on the Borg Rating of Perceived Exertion scale. Once
      fatigue is reached, data will be collected for 4000 frames (15-20 steps).

      Strengthening exercises During the first visit, a physical-therapist investigator will
      instruct subjects in strengthening exercises for the feet and legs. These activities will
      prepare musculoskeletal tissues to adapt to new forces they will experience during gait
      retraining. Subjects will be instructed to perform the exercises daily for 4 weeks, and will
      be given a journal to record their exercise performance. One week after exercise instruction,
      subjects will meet with the physical therapist-investigator to review the strengthening
      exercises and report any questions or concerns.

      Gait Retraining

      There will be 8 gait-retraining sessions over a 2-3 week time period. Subjects will be
      randomly assigned to either an increased cadence gait or a forefoot strike gait. The gait
      retraining protocols will be conducted on a treadmill (Woodway) in the clinic of the
      Spaulding National Running Center in the following manner:

      Increased cadence (CAD) Protocol: After a 3-minute warm up, subjects' preferred step rate
      will be determined during their self-selected moderate intensity run for an additional 3
      minutes using a visual count of footstrikes. Subjects will then be asked to increase their
      normal cadence by 7.5 percent while maintaining their speed. This will be accomplished by
      having subjects match their footstrikes to the beat of an audible digital metronome.

      Forefoot strike (FFS) Protocol: Subjects will wear an accelerometer on the right anterior
      distal tibial. After a 3-minute warm up run, subjects will continue running for an additional
      3 minutes and a baseline rearfoot strike accelerometer value will be recorded. Next, subjects
      will be instructed to land gently on the ball of their foot and lower their heels to the
      ground. They will be guided with verbal cues and visual inspection from a physical therapist.
      A forefoot strike accelerometer value will be recorded. If this value is exceeded, the device
      will provide audible feedback when a heel strike is detected signaling the runner to land
      with a FFS pattern.

      For both groups, run time will be gradually increased from 10-30 minutes over 8 sessions. The
      auditory feedback will be provided constantly for the first 4 sessions and then gradually
      decreased in a systematic manner for the last four sessions. This feedback schedule has
      produced successful outcomes in a number of gait retraining studies.4,5,6 The feedback
      schedule for both groups is detailed as follows:

      Session 1 - 10 minute treadmill run with metronome auditory feedback 100 percent of the time

      Sessions 2,3,4 - Time of run will be gradually increased over sessions 2,3,4 to 12, 15, and
      18 minutes respectively. Auditory feedback 100 percent of the time.

      Sessions 5,6,7,8 - Time of run will be gradually increased over sessions 5,6,7,8 to 21,24,27,
      and 30 minutes respectively. Auditory feedback will be gradually reduced and given only at
      the beginning, middle, and end of a run.

      This will be 4 minutes for sessions 5; 3 minutes for session 6; 2 minutes for session 7; and
      1 minute for session 8.

      Participants will be instructed not to run at any other time outside of the gait-retraining
      period. After completion of gait retraining, subjects will be encouraged to continue their
      new gait pattern as they run independently in the community. They will be instructed to
      increase running distance by no greater than 10 percent per week until they reach their
      desired running duration or distance. Subjects will be asked to keep journals of running
      activity after gait retraining until they return for the final gait analysis. This will be
      done via the REDCap (Research Electronic Data Capture) secure web application.

      Data to be collected and when the data is to be collected:

      Biomechanical outcomes as described above will be collected during each of the 5
      biomechanical analyses that participants attend at the Spaulding National Running Center.
      Every effort will be made to accommodate participants' schedules for these sessions. Data
      collection will occur at the first visit (baseline), 1 week following gait retraining
      (approximately 7 to 8 weeks from baseline), 1 month after gait retraining (approximately 11
      weeks from baseline), and 6 months after gait retraining (approximately 35 weeks from
      baseline).

      Journals of daily strengthening exercise performance will be collected at Visit 3 (4 weeks
      from baseline). Journals of running frequency and distance and any discomfort or injuries
      will be collected throughout the 6 month follow up period using REDCap secure web application
      (9 to 35 weeks from baseline).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Vertical Load Rates
time frame: baseline, 1 week follow up, 1 month follow up, 6 month follow up
description: average rate of loading calculated from Vertical Ground Reaction Force
measure: Change in Foot Angle
time frame: baseline, 1 week follow up, 1 month follow up, 6 month follow up
description: angle of foot in relation to ground, determines foot strike type
measure: Change in running cadence (steps per minute)
time frame: baseline, 1 week follow up, 1 month follow up, 6 month follow up
description: number of steps taken per minute
arm group label: Cadence
arm group type: Experimental
description: Runners who use an increased running cadence of 7.5 percent over preferred running cadence.
arm group label: Forefoot Strike
arm group type: Experimental
description: Runners who use a forefoot strike instead of a rear foot strike
intervention type: Other
intervention name: Increased running cadence gait retraining
description: Runners use an increased cadence, or step rate, 7.5% greater than baseline preferred cadence
arm group label: Cadence
intervention type: Other
intervention name: Forefoot Strike gait retraining
description: Runners use a forefoot strike running gait instead of a rear foot strike running gait.
arm group label: Forefoot Strike
intervention type: Other
intervention name: Strengthening exercises
description: foot and ankle strengthening exercises performed by all subjects to prepare musculoskeletal tissues for requirements of new running gait.
arm group label: Cadence
arm group label: Forefoot Strike
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Irene Davis, PhD
role: Study Director
affiliation: Director, Spaulding National Running Center
responsible party type: Principal Investigator
investigator affiliation: Spaulding Rehabilitation Hospital
investigator full name: Irene Sprague Davis
investigator title: Director, Spaulding National Running Center
sharing ipd: No