Gait Retraining Enhances Athletes' Technique

Study Overview
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Brief Summary
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The participant population for this study will be a convenience sample of 40 active duty soldiers and cadets at West Point, New York (NY) who are recovering from anterior cruciate ligament reconstruction (ACLR) and are cleared to return to run by their medical provider. Two groups will be utilized in this pre-test, post-test, single-blind randomized controlled trial study design. The purpose of this study is to determine if patients recovering from ACLR benefit from running gait retraining to adopt a forefoot strike pattern and 5-10% increase in step rate when compared to a traditional walk to run program.

Detailed Description
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The participant population for this study will be a convenience sample of 40 active duty soldiers and cadets at West Point, NY who are recovering from Anterior Cruciate Ligament Reconstruction (ACLR) and are cleared to return to run by their medical provider. Two groups will be utilized in this repeated measures, single-blind, randomized controlled trial study design. The purpose of this study is to determine if patients recovering from ACLR benefit from running gait retraining when compared to a traditional walk-to-run program. Patient reported outcome measures, running kinetic data and running kinematic data, along with biomarkers of cartilage turnover and clinical outcomes will be assessed in two groups of post-operative ACLR patients. All participants, regardless of group, will be instructed in a 4-week home exercise program to ensure runners have adequate strength prior to returning to full running activities. They will be provided an instructional handout and compliance log at the date of their initial running biomechanical assessment. The home exercise program will consist of exercises focused on stretching and strengthening of the hip, knee, calf and foot musculature. One group will receive technology assisted clinician guided gait retraining to reduce lower extremity loading parameters (intervention) while the control group will return to running with a traditional return to run program (control). Regardless of group, all runners will have their running form and foot strike pattern analyzed using an instrumented treadmill and high-speed motion capture initially, at the pre-intervention, post-intervention, and follow-up time point. During the intervention period, regardless of group, all runners will complete in-clinic follow-ups with their study assigned medical provider. During these visits the control group will only receive standard run program feedback. During these visits the intervention group will receive technology-guided clinician-assisted gait retraining cues to reduce ground reaction forces during running. Kinetic data, kinematic data, and perceived running pain and running function will be collected at the pre-intervention, post-intervention and follow-up timepoints to include average vertical loading rate (AVLR), AVLR symmetry, impulse, foot strike pattern (FSP), contact time, step length, step rate, Visual Analog Scale for Running Pain during running, Visual Analog Scale for Running Pain worst pain, Visual Analog Scale for Running Pain during after running, Single Assessment Numeric Evaluation, Knee Injury and Osteoarthritis Outcome Score (KOOS), and University of Wisconsin Running and Recovery Index (UWRI). Biological samples will be collected from all runners regardless of group at the pre-intervention time point and the post-intervention timepoint. Biological samples will be tested using ELISA for several biomarkers of interest and the concentration of these biomarkers will be compared within and between groups over time. A pan-omics (e.g. metabolomics, proteomics, and transcriptomics) approach will be used to test for novel biomarkers that will also compare within and between groups over time. Our military service members are at greater risk of ACL injury, greater risk of early onset knee Osteoarthritis (OA), and are required to maintain high levels of fitness to remain in the military. It is therefore clinically important to identify interventions to improve patient reported outcomes, return to duty rates, and reduce lower extremity loading parameters in military service members returning to run after ACLR.

Official Title
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Gait Retraining Enhances Athletes' Technique: GREAT After Anterior Cruciate Ligament Reconstruction

Conditions
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Anterior Cruciate Ligament Injury, Knee Osteoarthritis

Intervention / Treatment
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* Other: Therapeutic Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to give informed consent Between 18-50 years of age Active duty Soldier or cadet History of Anterior Cruciate Ligament Reconstruction in the last 18 months Cleared to return to run by their Department of Defense medical provider (primary care physician, orthopedic surgeon, physical therapist, or athletic trainer) Ability to perform 20 unassisted single leg heel raises bilaterally Ability to perform 10 pain-free, symmetrical, single-leg squats to between 45-60 degrees bilaterally Ability to perform 20 pain-free single leg hops in place bilaterally Exclusion Criteria: Currently on an Army running limiting profile Concomitant Posterior Cruciate Ligament or Lateral Cruciate Ligament injury Concomitant meniscectomy >50% History of inflammatory arthritis or gout History of ACL injury to either knee History of major lower-extremity joint injury and/or surgery Known pregnancy currently or in the previous 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pre-test, post-test, single-blind randomized controlled trial study design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The experimental group participants (approximately 20 participants) will receive, a standard graduated return-to-run program, a 4-week lower-extremity exercise program, and an activity log to track exercise progress. Participants will be instructed to follow-up with their research physical therapist once a week for the first 4 weeks and then every other week until the run progression is completed. During follow-ups experimental group participants will receive gait retraining cues to transition to a NRFS running pattern. | Other: Therapeutic Intervention<br>* Instruction for all participants in the experimental group will begin with transitioning foot strike pattern from a rearfoot strike to a non-rearfoot strike running pattern (NRFS) and increasing preferred step rate by 5-10%. Each participant program thereafter will be progressed individually according to the clinical investigators follow up assessments of running mechanics and participant pain and function with running. Intervention gait retraining sessions will include drills for reinforcement to include soft landing single leg bounding, adequate time to practice, and pre-class and post-class video assessment with feedback.<br>* Other names: Gait Retraining;|
| No Intervention: Control Group<br>The control group participants (approximately 20 participants) will receive, a standard graduated return-to-run program, a 4-week lower-extremity exercise program, and an activity log to track exercise progress. Participants will be instructed to follow-up with their research physical therapist once a week for the first 4 weeks and then every other week until the run progression is completed. During follow-ups control group participants will not receive any gait retraining cues and will only be instructed on standard of care return to run metrics to include volume, load, and duration of running. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) During Running Pain | VAS, measures self-reported pain, scored on a 0-10 scale with 0 being no pain and 10 being worst pain imaginable. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Subjective Knee Evaluation Form | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of Wisconsin Running and Recovery Index (UWRI) | UWRI, scored on a scale from 0-36 with 36 equaling completion of running function and a score of 0 equating to inability to run. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 
| CPII Serum Biomarker Concentration | Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 
| C1 Serum Biomarker Concentration | Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 
| 2C Serum Biomarker Concentration | Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 
| C2C Serum Biomarker Concentration | Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 
| CTX-1 Serum Biomarker Concentration | Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 
| NTX Serum Biomarker Concentration | Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 
| Average Vertical Loading Rate (AVLR) | A vertical ground reaction force measure that indicates how quickly force is being applied to the body. | Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Running, Gait Retraining, Return to Run, ACLR, Loading