Gait-Training Using Wearable Sensors

Gait-Training Using Wearable Sensors for Runners With Exercise-Related Lower Leg Pain

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).

Study Overview

• Status: Completed
• Conditions: Shin Splint; Running-related Injury
• Intervention / Treatment: Behavioral: In-Field Gait-Training; Behavioral: Home Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • Memorial Gymnasium - Exercise and Sport Injury Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 18-45 years
• Male or female
• Involved in running training at least two times per week over the past three months
• Current weekly mileage of at least 6 miles
• Currently experiencing pain during or after running in the anterior or medial aspect of the leg (between the knee and the ankle) of at least one week in duration, with maximum pain levels between 3/10 and 8/10 on the Visual Analogue Scale
• All subjects must be willing to use their own smart phone device (iPhone or Android) to download the RunScribe application for study procedures.

Exclusion Criteria:

• Primary complaint is of pain over the Achilles tendon, popliteal fossa, or lateral or superficial posterior compartment of the lower leg
• Medical diagnosis of compartment syndrome, tibial or fibular stress fracture, or tibial or fibular fracture within the past 3 months
• Current running-related injuries within 3 months at the foot, ankle, knee, thigh, hip, or lower back
• Any history of lower extremity or lower back surgery
• Subjects with known pregnancy
• Subject with any type of neuropathy (numbness/tingling) in lower extremity
• Subject with clinical diagnosis of Parkinson's disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; The intervention group will receive real-time gait-training interventions along with a home exercise program. Participants in this group will be given a pair of sensors to wear on their shoes to wear during runs throughout the study period, and wear a Garmin watch to get information from the sensors to the watch for feedback. They will also do home exercises during the study, and to come into the laboratory weekly for about 30 minutes per visit to progress the home exercises and get instructions on feedback for the next week.	Behavioral: In-Field Gait-Training; 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.; Other Names: RunScribe; Garmin; Behavioral: Home Exercise; Participants will receive a series of exercises based on noted impairments at baseline. Exercises will be completed twice per week for four weeks.
ACTIVE_COMPARATOR: Control Group; The control group will receive only a home exercise program. Participants in this group will be given a pair of sensors to wear on their shoes to wear during runs throughout the study period, and do home exercises during the study. Participants will be asked to come into the laboratory weekly for about 30 minutes per visit to progress the home exercises.	Behavioral: Home Exercise; Participants will receive a series of exercises based on noted impairments at baseline. Exercises will be completed twice per week for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Contact Time	the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors	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	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	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	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	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	This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Pain Outcomes	Visual Analog Scale (0-100 mm) pain outcome scores	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	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	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	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	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	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	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	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	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	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	This outcome change will be assessed through study completion over 4 weeks for both groups.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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%)	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%)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.

Collaborators and Investigators

• Sponsor: University of Virginia

Publications and helpful links

General Publications

• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
• Willy RW. Innovations and pitfalls in the use of wearable devices in the prevention and rehabilitation of running related injuries. Phys Ther Sport. 2018 Jan;29:26-33. doi: 10.1016/j.ptsp.2017.10.003. Epub 2017 Oct 6.
• Koldenhoven RM, Hertel J. Validation of a Wearable Sensor for Measuring Running Biomechanics. Digit Biomark. 2018 Aug 2;2(2):74-78. doi: 10.1159/000491645. eCollection 2018 May-Aug.
• Hollis CR, Koldenhoven RM, Resch JE, Hertel J. Running biomechanics as measured by wearable sensors: effects of speed and surface. Sports Biomech. 2021 Aug;20(5):521-531. doi: 10.1080/14763141.2019.1579366. Epub 2019 Mar 7. Erratum In: Sports Biomech. 2019 May 31;:1.
• DeJong AF, Hertel J. Gait-training devices in the treatment of lower extremity injuries in sports medicine: current status and future prospects. Expert Rev Med Devices. 2018 Dec;15(12):891-909. doi: 10.1080/17434440.2018.1551130. Epub 2018 Dec 10.
• Willems TM, Witvrouw E, De Cock A, De Clercq D. Gait-related risk factors for exercise-related lower-leg pain during shod running. Med Sci Sports Exerc. 2007 Feb;39(2):330-9. doi: 10.1249/01.mss.0000247001.94470.21.
• Reinking MF, Hayes AM. Intrinsic factors associated with exercise-related leg pain in collegiate cross-country runners. Clin J Sport Med. 2006 Jan;16(1):10-4. doi: 10.1097/01.jsm.0000188041.04760.d2.
• Korakakis V, Malliaropoulos N, Baliotis K, Papadopoulou S, Padhiar N, Nauck T, Lohrer H. Cross-cultural Adaptation and Validation of the Exercise-Induced Leg Pain Questionnaire for English- and Greek-Speaking Individuals. J Orthop Sports Phys Ther. 2015 Jun;45(6):485-96. doi: 10.2519/jospt.2015.5428. Epub 2015 Apr 30.
• Abbott JH, Wright AA. Global Rating of Change (GROC): the minimally important change at which patients choose to stop seeking treatment. N Z J Physiother. 2010;38(2):66-66.
• Nelson EO, Ryan M, AufderHeide E, Heiderscheit B. Development of the University of Wisconsin Running Injury and Recovery Index. J Orthop Sports Phys Ther. 2019 Oct;49(10):751-760. doi: 10.2519/jospt.2019.8868. Epub 2019 Aug 3.
• DeJong Lempke AF, Stephens SL, Fish PN, Thompson XD, Hart JM, Hryvniak DJ, Rodu JS, Hertel J. Sensor-based gait training to reduce contact time for runners with exercise-related lower leg pain: a randomised controlled trial. BMJ Open Sport Exerc Med. 2022 Nov 3;8(4):e001293. doi: 10.1136/bmjsem-2021-001293. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 5, 2020
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: running; wearable sensors; gait-training; exercise-related lower leg pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Medial Tibial Stress Syndrome
• Other Study ID Numbers: 22107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No