Clinical trial NCT04270565: Gait-Training Using Wearable Sensors
Official title: Gait-Training Using Wearable Sensors for Runners With Exercise-Related Lower Leg Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shin Splint
Running-related Injury
Keywords: running
gait-training
exercise-related lower leg pain
wearable sensors
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups:

1. real-time gait-training interventions along with a home exercise program (intervention group)
2. only home exercise program (control group).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Contact Time
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Contact Time Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Maintaining Change in Contact Time
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Change in Hip Frontal Plane Motion
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Gluteus Medius Electromyography
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Tibialis Anterior Electromyography
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Pain Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Maintaining Change in Pain Outcomes
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Maintaining Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Change in Pain Outcomes Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Step Rate
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Stride Length
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Maximum Pronation Velocity
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Shock
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Foot Strike Type
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Secondary outcomes:
measure: Change in Peroneus Longus Electromyography
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Medial Gastocnemius Electromyography
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Foot Strike Type Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Change in Shock Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Change in Maximum Pronation Velocity Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Change in Stride Length Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Change in Step Rate Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Maintaining Change in Foot Strike Type
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Maintaining Change in Shock
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Maintaining Change in Maximum Pronation Velocity
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Maintaining Change in Stride Length
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Maintaining Change in Step Rate
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Change in Hip Sagittal Plane Motion
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Sagittal Plane Kinetics
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Transverse Plane Motion
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Transverse Plane Kinetics
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Frontal Plane Kinetics
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Knee Frontal Plane Motion
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Knee Frontal Plane Kinetics
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Knee Sagittal Plane Kinetics
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Sagittal Plane Motion
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Sagittal Plane Kinetics
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Knee Sagittal Plane Motion
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Trunk Frontal Plane Motion
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Trunk Sagittal Plane Motion
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Trunk Frontal Plane Kinetics
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Trunk Sagittal Plane Kinetics
timeFrame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
measure: Maintaining Global Change Outcomes
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Maintaining Recovery Outcomes
timeFrame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
measure: Change in Recovery Outcomes Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Change in Global Change Outcomes Across the Intervention Period
timeFrame: This outcome change will be assessed through study completion over 4 weeks for both groups.
measure: Change in Single-Leg Squat Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Lateral Step-Down Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Star Excursion Balance Test Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Visual Gait Analysis Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Foot Posture Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Arch Height Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Weight-Bearing Dorsiflexion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Plantarflexion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Dorsiflexion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Metatarsophalangeal Joint Flexion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Metatarsophalangeal Joint Extension Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Abduction Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Inversion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Eversion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Knee Flexion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Tibial Torsion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Anteversion Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hamstring Flexibility Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Flexor Flexibility Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Metatarsophalangeal Joint Flexion Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Dorsiflexion Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Plantarflexion Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Inversion Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Ankle Eversion Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Flexion Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Extension Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Hip Abduction Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Knee Extensor Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
measure: Change in Knee Flexor Strength Outcomes
timeFrame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: Memorial Gymnasium - Exercise and Sport Injury Laboratory
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jay Hertel, PhD
role: PRINCIPAL_INVESTIGATOR
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