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Completed

NCT Number: NCT04270565

Gait-Training Using Wearable Sensors

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).

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Gymnasium - Exercise and Sport Injury Laboratory

Charlottesville, Virginia, 22904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: RunScribe, Garmin

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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