Gait Retraining Enhances Athletes' Technique (GREAT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis; Anterior Cruciate Ligament Injury
• Intervention / Treatment: Other: Therapeutic Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin M Miller, MS, ABD; Phone Number: 845-987-0029; Email: erin.florkiewicz@gmail.com
• Study Contact Backup: Name: Michael Crowell, DSc; Phone Number: 845-938-3067; Email: michaelcrowell99@gmail.com

Study Locations

• United States
  • New York
    • West Point, New York, United States, 10996
      • Recruiting
      • Keller Army Community Hospital
      • Contact: Erin M Miller, MS, ABD; Phone Number: 845-987-0029; Email: erin.florkiewicz@gmail.com
      • Contact: Michael Crowell, DSc; Phone Number: 845-938-3067; Email: michaelcrowell99@gmail.com
      • Principal Investigator: Erin M Miller, MS,ABD
      • Sub-Investigator: Michael Crowell, DSc
      • Sub-Investigator: Donald Goss, PhD
      • Sub-Investigator: John Mason, DSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able and willing to give informed consent
2. Between 18-50 years of age
3. Active duty Soldier or cadet
4. History of Anterior Cruciate Ligament Reconstruction in the last 18 months
5. Cleared to return to run by their Department of Defense medical provider (primary care physician, orthopedic surgeon, physical therapist, or athletic trainer)
6. Ability to perform 20 unassisted single leg heel raises bilaterally
7. Ability to perform 10 pain-free, symmetrical, single-leg squats to between 45-60 degrees bilaterally
8. Ability to perform 20 pain-free single leg hops in place bilaterally

Exclusion Criteria:

1. Currently on an Army running limiting profile
2. Concomitant Posterior Cruciate Ligament or Lateral Cruciate Ligament injury
3. Concomitant meniscectomy >50%
4. History of inflammatory arthritis or gout
5. History of ACL injury to either knee
6. History of major lower-extremity joint injury and/or surgery
7. Known pregnancy currently or in the previous 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; 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; 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.; Other Names: Gait Retraining
NO_INTERVENTION: Control Group; 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?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Specific Functional Scale (PSFS)	PSFS, scored on a 0-10 scale with six pre-filled items: walking, running on level ground less than 2 miles, running uphill, running downhill, running on level ground greater than 2 miles, and hopping/jumping).	Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks)
Single Assessment Numeric Evaluation (SANE)	SANE, scored on a 0-100% scale with 100% equaling completion of function	Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks)
Peak Vertical Ground Reaction Force	A vertical ground reaction force measure that indicates how the peak force 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)
Braking Force	A vertical ground reaction force measure that indicates the amount of anterior force 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)
Vertical Center of Mass Displacement	The difference between the highest vertical and lowest vertical point achieved during a running stride.	Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks)

Collaborators and Investigators

• Sponsor: Keller Army Community Hospital
• Collaborators: Telemedicine & Advanced Technology Research Center
• Investigators: Principal Investigator: Erin M Miller, MS, ABD, Keller Army Community Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (ACTUAL): April 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Running; Loading; ACLR; Gait Retraining; Return to Run
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Knee Injuries; Osteoarthritis; Osteoarthritis, Knee; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 19KACH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No