Gait-Training Using Wearable Sensors

NCT04270565 | Completed DMC

• 1 other identifier: 22107
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Shin Splint; Running-related Injury

Keywords

running; gait-training; exercise-related lower leg pain; wearable sensors

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (60)

• Change in Peroneus Longus Electromyography

  This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.

• Change in Medial Gastocnemius Electromyography

  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

  This outcome change will be assessed through study completion over 4 weeks for both groups.

• Change in Shock Across the Intervention Period

  This outcome change will be assessed through study completion over 4 weeks for both groups.

• Change in Maximum Pronation Velocity Across the Intervention Period

  This outcome change will be assessed through study completion over 4 weeks for both groups.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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; Behavioral: Home Exercise

Control Group

ACTIVE COMPARATOR

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

Interventions

In-Field Gait-Training BEHAVIORAL

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.

Also known as: RunScribe, Garmin

Intervention Group

Home Exercise BEHAVIORAL

Participants will receive a series of exercises based on noted impairments at baseline. Exercises will be completed twice per week for four weeks.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

Memorial Gymnasium - Exercise and Sport Injury Laboratory

Charlottesville, Virginia, 22904, United States

Location

Related Publications (11)

• 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.

  PMID: 29172095 BACKGROUND

• 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.

  PMID: 32095758 BACKGROUND

• 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.

  PMID: 30843475 BACKGROUND

• 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.

  PMID: 30466335 BACKGROUND

• 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.

  PMID: 17277598 BACKGROUND

• 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.

  PMID: 16377969 BACKGROUND

• 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.

  PMID: 11733293 BACKGROUND

• 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.

  PMID: 25927499 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31378123 BACKGROUND

• 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.

  PMID: 36353183 DERIVED

MeSH Terms

Conditions

Medial Tibial Stress Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Leg Injuries; Wounds and Injuries

Study Officials

• Jay Hertel, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The investigator assessing laboratory-based outcome measures will be blinded to group allocation. Additionally, the investigator designing the home exercise program and making progression decisions will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joe H. Gieck Professor of Sports Medicine

Model Details: 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).

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: February 5, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)