Gait-Training Using Wearable Sensors
Condition: Shin Splint; Running-related Injury
MeSH terms: Medial Tibial Stress Syndrome
Study type: Interventional

Summary: 
      The overarching purpose of this project is to use sensor-derived patterns to guide running
      interventions during in-field training scenarios for runners with exercise-related lower leg
      pain. The investigators plan to use the RunScribe sensors to facilitate in-field
      gait-training to determine the effects of real-time gait-training interventions along with a
      home exercise program (intervention group) on biomechanical and patient-reported outcome
      measures of pain and function in runners with leg pain as opposed to receiving a home
      exercise program alone (control group).
    

Detailed description: 
      The purpose of the study is to determine the effects of real-time gait-training interventions
      along with a home exercise program (intervention group) on biomechanical and patient-reported
      outcome measures of pain and function in runners with leg pain as opposed to receiving a home
      exercise program alone (control group). All participants will report to the Exercise and
      Sport Injury Laboratory for a 60-minute baseline clinical assessment performed by a blinded
      assessor to determine hip, knee, foot and ankle strength, range of motion, and alignment
      using valid and reliable measurement techniques. Participants will also perform a series of
      functional movement assessments while an assessor records frontal and sagittal camera views
      in order to determine lower extremity dynamic alignment. The functional assessments will
      include the star excursion balance test (SEBT), a lateral step-down, a single-leg squat to 45
      degrees of knee flexion, and a treadmill gait assessment. The movement screens will be use to
      form criteria-based home exercise programs, such that a blinded assessor will evaluate the
      videos and categorize patients into varus, valgus, or neutral alignment groups. Participants
      will receive exercises tailored to these descriptions. Further, the static alignment
      measurements will be used to determine if lower extremity stretches are warranted.

      Following the first baseline visit, participants will return to the lab for a second baseline
      visit to complete an indoor, instrumented gait analysis using a motion capture system.
      Participants will also become oriented to the RunScribe wearable sensors and associated phone
      application, and will perform a brief outdoor run at their preferred speed to calibrate the
      sensors. Participants will receive their home exercise prescription with supplemental videos
      to take home with them to ensure adequate understanding of the target exercise performance.
      Participants will then be randomly assigned to one of two groups: 1) sensor-based feedback
      with home exercises (intervention group), or 2) home exercises alone (control group). The
      randomization sequence will be created a priori with a random-number generator stratified by
      sex, and allocation will be placed in a sealed opaque envelope by the graduate student mentor
      to intentionally blind the study coordinator conducting the interventions.

      Participants in the intervention group will receive a Garmin wristwatch to facilitate the
      gait-training feedback, and will be oriented to the procedures during 10 minutes of running
      on an indoor treadmill in the presence of the study coordinator to ensure adequate
      understanding and integration of the feedback. The RunScribe sensors will facilitate the
      feedback by providing real-time metrics on the Garmin watch face using a custom application.
      Contact time will be the central focus of the intervention; participants will receive a
      vibro-tactile alert to remain below the identified contact time cut-off based on preliminary
      data.

      Regardless of group allocation, participants will be instructed to maintain a running log
      within the RunScribe phone application to track activity adherence, details of runs that are
      recorded by the sensors, and report pain 1-10 experienced before, during, and after runs. All
      participants will be asked to perform their interventions twice per week. Participants will
      be encouraged to maintain other normal activities in addition to the interventions.

      During the intervention period, all participants will return to the lab once per week to
      determine if exercise progressions are warranted based using specific performance-based
      scoring criteria. These decisions will be made by an assessor blinded to group allocation.
      The intervention group participants will then check in with the unblinded study coordinator
      to receive instructions on gait-training feedback progressions. The intervention will follow
      a volume-based faded feedback design.

      At the midpoint of the study, all participants will complete Visual Analog and Global Rating
      of Change scales to track self-reported recovery. At the end of the intervention period, all
      participants will be re-assessed by the same blinded assessor using the same baseline
      measures to determine changes in lower limb alignment, strength, flexibility, and functional
      movement patterns. The indoor gait assessment and calibration run performed at the second
      baseline visit will be repeated at this follow-up timepoint while all participants wear the
      RunScribe sensors. Participants will also repeat Visual Analog Pain and Global Rating of
      Change scales to assess self-reported recovery. The investigators will then be able to
      determine if contact time feedback delivered in the field effectively decreases contact time
      after feedback compared to baseline and compared to the control group, determine if contact
      time feedback delivered in the field carries over to other gait outcomes in the intervention
      group after gait-training compared to baseline and the control group, and assess if pain
      decreases and function increases after gait-training compared to baseline and to a greater
      extent than the control group.
    

Intervention name(s): In-Field Gait-Training; Home Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will deliver a series of vibrations on the participants' wrists through the Garmin when the sensors indicate that their contact time in milliseconds exceeds a threshold. The runners will be asked to reduce the amount of time their foot is in contact with the ground by picking their feet up more quickly. Participants will also receive a series of exercises based on noted impairments at baseline. The feedback during running will be completed twice per week for four weeks.; Participants will receive a series of exercises based on noted impairments at baseline. Exercises will be completed twice per week for four weeks.
Other intervention name(s): RunScribe; Garmin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two groups:
real-time gait-training interventions along with a home exercise program (intervention group)
only home exercise program (control group).
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: running; gait-training; exercise-related lower leg pain; wearable sensors