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).
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.
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.
Memorial Gymnasium - Exercise and Sport Injury Laboratory
Charlottesville, Virginia, United States
Change in Contact Time
the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Contact Time Across the Intervention Period
the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Maintaining Change in Contact Time
the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Change in Hip Frontal Plane Motion
Hip frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Gluteus Medius Electromyography
Normalized gluteus medius muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Tibialis Anterior Electromyography
Normalized tibialis anterior muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Change in Pain Outcomes
Visual Analog Scale (0-100 mm) pain outcome scores
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Maintaining Change in Pain Outcomes
Visual Analog Scale (0-100 mm) pain outcome scores
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Maintaining Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Change in Pain Outcomes Across the Intervention Period
Visual Analog Scale (0-100 mm) pain outcome scores
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Step Rate
the step rate per minute (in steps/min) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Stride Length
the distance the legs reach out (in meters) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Maximum Pronation Velocity
the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Shock
the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Foot Strike Type
the area on the foot that participants land on (on a 1-16 scale, with 1 indicating rear foot strike and 16 indicating a forefoot strike) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes Across the Intervention Period
Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Peroneus Longus Electromyography
Normalized peroneus longus muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Medial Gastocnemius Electromyography
Normalized medial gastrocnemius muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Foot Strike Type Across the Intervention Period
the area on the foot that participants land on (on a 1-16 scale, with 1 indicating rear foot strike and 16 indicating a forefoot strike) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Shock Across the Intervention Period
the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Maximum Pronation Velocity Across the Intervention Period
the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Stride Length Across the Intervention Period
the distance the legs reach out (in meters) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Step Rate Across the Intervention Period
the step rate per minute (in steps/min) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Maintaining Change in Foot Strike Type
the area on the foot that participants land on (on a 1-16 scale, with 1 indicating rear foot strike and 16 indicating a forefoot strike) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Maintaining Change in Shock
the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Maintaining Change in Maximum Pronation Velocity
the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Maintaining Change in Stride Length
the distance the legs reach out (in meters) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Maintaining Change in Step Rate
the step rate per minute (in steps/min) during running as measured using the RunScribe sensors
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Change in Hip Sagittal Plane Motion
Hip sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Sagittal Plane Kinetics
Hip sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Transverse Plane Motion
Hip transverse plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Transverse Plane Kinetics
Hip transverse plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Frontal Plane Kinetics
Hip frontal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Knee Frontal Plane Motion
Knee frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Knee Frontal Plane Kinetics
Knee frontal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Knee Sagittal Plane Kinetics
Knee sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Sagittal Plane Motion
Ankle sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Sagittal Plane Kinetics
Ankle sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Knee Sagittal Plane Motion
Knee sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Trunk Frontal Plane Motion
Trunk frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Trunk Sagittal Plane Motion
Trunk sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Trunk Frontal Plane Kinetics
Trunk frontal plane joint moment (in Nm/kg)measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Trunk Sagittal Plane Kinetics
Trunk sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Maintaining Global Change Outcomes
Global Rating of Change Scale (11-point scale)
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Maintaining Recovery Outcomes
Wisconsin Injury and Recovery Scale (0-100%)
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Change in Recovery Outcomes Across the Intervention Period
Wisconsin Injury and Recovery Scale (0-100%)
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Global Change Outcomes Across the Intervention Period
Global Rating of Change Scale (11-point scale)
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Single-Leg Squat Outcomes
single-leg squat to 45 degrees of knee flexion functional performance scores (valgus, varus, or neutral scoring)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Lateral Step-Down Outcomes
lateral step-down from a 35 cm box functional performance scores (valgus, varus, or neutral scoring)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Star Excursion Balance Test Outcomes
star excursion balance test performance scores (reach distances as a % of leg length for 8 reach directions)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Visual Gait Analysis Outcomes
visual gait assessment functional performance score (valgus, neutral, or varus)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Foot Posture Outcomes
Clinical foot posture index assessment (23-point scale)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Arch Height Outcomes
Clinical arch height index assessment using a Jaktool (ratio of seated to standing measures)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Weight-Bearing Dorsiflexion Outcomes
Clinical weight-bearing dorsiflexion (knee-to-wall) assessment (in centimeters)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Plantarflexion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Dorsiflexion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Metatarsophalangeal Joint Flexion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Metatarsophalangeal Joint Extension Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Abduction Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Inversion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Eversion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Knee Flexion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Tibial Torsion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Anteversion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hamstring Flexibility Outcomes
Clinical test assessing hamstring flexibility, called the 90/90 straight leg raise test (in degrees)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Flexor Flexibility Outcomes
Clinical test assessing hip flexor flexibility, called the Thomas test (in centimeters)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Metatarsophalangeal Joint Flexion Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Dorsiflexion Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Plantarflexion Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Inversion Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Eversion Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Flexion Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Extension Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Abduction Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Knee Extensor Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Knee Flexor Strength Outcomes
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.