Gait Retraining Enhances Athletes' Technique (GREAT)

• ClinicalTrials.gov Identifier: NCT03918681
• Recruitment Status: Recruiting
• First Posted: April 17, 2019
• Last Update Posted: September 10, 2019
• Sponsor: Keller Army Community Hospital
• Collaborator: Telemedicine & Advanced Technology Research Center
• Information provided by (Responsible Party): Erin M. Miller, Keller Army Community Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anterior Cruciate Ligament Injury; Knee Osteoarthritis	Other: Therapeutic Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: pre-test, post-test, single-blind randomized controlled trial study design
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcomes assessors will be blind to treatment group.
• Primary Purpose: Treatment
• Official Title: Gait Retraining Enhances Athletes' Technique: GREAT After Anterior Cruciate Ligament Reconstruction
• Actual Study Start Date: August 1, 2019
• Estimated Primary Completion Date: January 1, 2021
• Estimated Study Completion Date: March 1, 2021

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. University of Wisconsin Running and Recovery Index (UWRI) [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   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.
2. CPII Serum Biomarker Concentration [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
3. C1 Serum Biomarker Concentration [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
4. 2C Serum Biomarker Concentration [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
5. C2C Serum Biomarker Concentration [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
6. CTX-1 Serum Biomarker Concentration [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
7. NTX Serum Biomarker Concentration [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
8. Average Vertical Loading Rate (AVLR) [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   A vertical ground reaction force measure that indicates how quickly force is being applied to the body.

Other Outcome Measures:

1. Patient Specific Functional Scale (PSFS) [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   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).
2. Single Assessment Numeric Evaluation (SANE) [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   SANE, scored on a 0-100% scale with 100% equaling completion of function
3. Peak Vertical Ground Reaction Force [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   A vertical ground reaction force measure that indicates how the peak force applied to the body.
4. Braking Force [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   A vertical ground reaction force measure that indicates the amount of anterior force applied to the body.
5. Vertical Center of Mass Displacement [ Time Frame: Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks) ]
   The difference between the highest vertical and lowest vertical point achieved during a running stride.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Erin M Miller, MS, ABD; 845-987-0029; erin.florkiewicz@gmail.com

Contact: Michael Crowell, DSc; 845-938-3067; michaelcrowell99@gmail.com

Locations

United States, New York

Keller Army Community Hospital; Recruiting

West Point, New York, United States, 10996

Contact: Erin M Miller, MS, ABD 845-987-0029 erin.florkiewicz@gmail.com

Contact: Michael Crowell, DSc 845-938-3067 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

Sponsors and Collaborators

Keller Army Community Hospital

Telemedicine & Advanced Technology Research Center

Investigators

• Principal Investigator: Erin M Miller, MS, ABD; Keller Army Community Hospital

More Information

• Responsible Party: Erin M. Miller, Research Program Manager, Keller Army Community Hospital
• ClinicalTrials.gov Identifier: NCT03918681
• Other Study ID Numbers: 19KACH001
• First Posted: April 17, 2019
• Last Update Posted: September 10, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erin M. Miller, Keller Army Community Hospital:

Running; Gait Retraining; Return to Run; ACLR; Loading

Additional relevant MeSH terms:

Osteoarthritis, Knee; Anterior Cruciate Ligament Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Knee Injuries; Leg Injuries; Wounds and Injuries