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Gait-Training Using Wearable Sensors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04270565
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jay Hertel, PhD, ATC, University of Virginia

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).

Condition or disease Intervention/treatment Phase
Shin Splint Running-related Injury Behavioral: In-Field Gait-Training Behavioral: Home Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Gait-Training Using Wearable Sensors for Runners With Exercise-Related Lower Leg Pain
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Contact Time [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors

  2. Change in Contact Time Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors

  3. Maintaining Change in Contact Time [ 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. ]
    the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors

  4. Change in Hip Frontal Plane Motion [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Hip frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill

  5. Change in Gluteus Medius Electromyography [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Normalized gluteus medius muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill

  6. Change in Tibialis Anterior Electromyography [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Normalized tibialis anterior muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill

  7. Change in Pain Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Visual Analog Scale (0-100 mm) pain outcome scores

  8. Maintaining Change in Pain Outcomes [ 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. ]
    Visual Analog Scale (0-100 mm) pain outcome scores

  9. Maintaining Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes [ 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. ]
    Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores

  10. Change in Pain Outcomes Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    Visual Analog Scale (0-100 mm) pain outcome scores

  11. Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores

  12. Change in Step Rate [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    the step rate per minute (in steps/min) during running as measured using the RunScribe sensors

  13. Change in Stride Length [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    the distance the legs reach out (in meters) during running as measured using the RunScribe sensors

  14. Change in Maximum Pronation Velocity [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors

  15. Change in Shock [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors

  16. Change in Foot Strike Type [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    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

  17. Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores


Secondary Outcome Measures :
  1. Change in Peroneus Longus Electromyography [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Normalized peroneus longus muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill

  2. Change in Medial Gastocnemius Electromyography [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Normalized medial gastrocnemius muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill

  3. Change in Foot Strike Type Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    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

  4. Change in Shock Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors

  5. Change in Maximum Pronation Velocity Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors

  6. Change in Stride Length Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    the distance the legs reach out (in meters) during running as measured using the RunScribe sensors

  7. Change in Step Rate Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    the step rate per minute (in steps/min) during running as measured using the RunScribe sensors

  8. Maintaining Change in Foot Strike Type [ 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. ]
    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

  9. Maintaining Change in Shock [ 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. ]
    the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors

  10. Maintaining Change in Maximum Pronation Velocity [ 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. ]
    the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors

  11. Maintaining Change in Stride Length [ 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. ]
    the distance the legs reach out (in meters) during running as measured using the RunScribe sensors

  12. Maintaining Change in Step Rate [ 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. ]
    the step rate per minute (in steps/min) during running as measured using the RunScribe sensors

  13. Change in Hip Sagittal Plane Motion [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Hip sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill

  14. Change in Hip Sagittal Plane Kinetics [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Hip sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill

  15. Change in Hip Transverse Plane Motion [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Hip transverse plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill

  16. Change in Hip Transverse Plane Kinetics [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Hip transverse plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill

  17. Change in Hip Frontal Plane Kinetics [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Hip frontal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill

  18. Change in Knee Frontal Plane Motion [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Knee frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill

  19. Change in Knee Frontal Plane Kinetics [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Knee frontal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill

  20. Change in Knee Sagittal Plane Kinetics [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Knee sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill

  21. Change in Ankle Sagittal Plane Motion [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Ankle sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill

  22. Change in Ankle Sagittal Plane Kinetics [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Ankle sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill

  23. Change in Knee Sagittal Plane Motion [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Knee sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill

  24. Change in Trunk Frontal Plane Motion [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Trunk frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill

  25. Change in Trunk Sagittal Plane Motion [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Trunk sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill

  26. Change in Trunk Frontal Plane Kinetics [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Trunk frontal plane joint moment (in Nm/kg)measured during the indoor motion capture gait analysis on a treadmill

  27. Change in Trunk Sagittal Plane Kinetics [ Time Frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. ]
    Trunk sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill

  28. Maintaining Global Change Outcomes [ 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. ]
    Global Rating of Change Scale (11-point scale)

  29. Maintaining Recovery Outcomes [ 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. ]
    Wisconsin Injury and Recovery Scale (0-100%)

  30. Change in Recovery Outcomes Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    Wisconsin Injury and Recovery Scale (0-100%)

  31. Change in Global Change Outcomes Across the Intervention Period [ Time Frame: This outcome change will be assessed through study completion over 4 weeks for both groups. ]
    Global Rating of Change Scale (11-point scale)

  32. Change in Single-Leg Squat Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    single-leg squat to 45 degrees of knee flexion functional performance scores (valgus, varus, or neutral scoring)

  33. Change in Lateral Step-Down Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    lateral step-down from a 35 cm box functional performance scores (valgus, varus, or neutral scoring)

  34. Change in Star Excursion Balance Test Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    star excursion balance test performance scores (reach distances as a % of leg length for 8 reach directions)

  35. Change in Visual Gait Analysis Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    visual gait assessment functional performance score (valgus, neutral, or varus)

  36. Change in Foot Posture Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical foot posture index assessment (23-point scale)

  37. Change in Arch Height Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical arch height index assessment using a Jaktool (ratio of seated to standing measures)

  38. Change in Weight-Bearing Dorsiflexion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical weight-bearing dorsiflexion (knee-to-wall) assessment (in centimeters)

  39. Change in Ankle Plantarflexion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  40. Change in Ankle Dorsiflexion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  41. Change in Metatarsophalangeal Joint Flexion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  42. Change in Metatarsophalangeal Joint Extension Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  43. Change in Hip Abduction Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  44. Change in Ankle Inversion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  45. Change in Ankle Eversion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  46. Change in Knee Flexion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  47. Change in Tibial Torsion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  48. Change in Hip Anteversion Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical range of motion assessment using standard goniometer (in degrees)

  49. Change in Hamstring Flexibility Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing hamstring flexibility, called the 90/90 straight leg raise test (in degrees)

  50. Change in Hip Flexor Flexibility Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing hip flexor flexibility, called the Thomas test (in centimeters)

  51. Change in Metatarsophalangeal Joint Flexion Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  52. Change in Ankle Dorsiflexion Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  53. Change in Ankle Plantarflexion Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  54. Change in Ankle Inversion Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  55. Change in Ankle Eversion Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  56. Change in Hip Flexion Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  57. Change in Hip Extension Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  58. Change in Hip Abduction Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  59. Change in Knee Extensor Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)

  60. Change in Knee Flexor Strength Outcomes [ Time Frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. ]
    Clinical test assessing strength using hand-held dynamometry (in N/kg)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270565


Contacts
Layout table for location contacts
Contact: Alexandra F DeJong, MEd 434-924-6184 afd4au@virginia.edu
Contact: Jay Hertel, PhD 434-243-8673 jnh7g@virginia.edu

Locations
Layout table for location information
United States, Virginia
Memorial Gymnasium - Exercise and Sport Injury Laboratory Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Jay Hertel, PhD    434-243-8673    jnh7g@virginia.edu   
Contact: Alexandra F DeJong, MEd    434-924-6184    afd4au@virginia.edu   
Sub-Investigator: Alexandra F DeJong, MEd         
Sub-Investigator: Stephanie L Stephens, MS         
Sub-Investigator: Xavier Thompson, MS         
Sub-Investigator: Pamela N Fish         
Sub-Investigator: Natalie A Kupperman, MEd         
Principal Investigator: Jay Hertel, PhD         
Sub-Investigator: Catherine Donahue, MEd         
Sub-Investigator: Amelia S Bruce, MS         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Jay Hertel, PhD University of Virginia
Publications:
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.

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Responsible Party: Jay Hertel, PhD, ATC, Joe H. Gieck Professor of Sports Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT04270565    
Other Study ID Numbers: 22107
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jay Hertel, PhD, ATC, University of Virginia:
running
gait-training
exercise-related lower leg pain
wearable sensors
Additional relevant MeSH terms:
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Medial Tibial Stress Syndrome
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Leg Injuries
Wounds and Injuries