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Gait Retraining Enhances Athletes' Technique (GREAT)

Primary Purpose

Anterior Cruciate Ligament Injury, Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Intervention
Sponsored by
Keller Army Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Running, Gait Retraining, Return to Run, ACLR, Loading

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keller Army Community HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Subjective Knee Evaluation Form

Secondary Outcome Measures

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.
CPII Serum Biomarker Concentration
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
C1 Serum Biomarker Concentration
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
2C Serum Biomarker Concentration
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
C2C Serum Biomarker Concentration
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
CTX-1 Serum Biomarker Concentration
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
NTX Serum Biomarker Concentration
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
Average Vertical Loading Rate (AVLR)
A vertical ground reaction force measure that indicates how quickly force is being applied to the body.

Full Information

First Posted
February 15, 2019
Last Updated
September 6, 2019
Sponsor
Keller Army Community Hospital
Collaborators
Telemedicine & Advanced Technology Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03918681
Brief Title
Gait Retraining Enhances Athletes' Technique
Acronym
GREAT
Official Title
Gait Retraining Enhances Athletes' Technique: GREAT After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keller Army Community Hospital
Collaborators
Telemedicine & Advanced Technology Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury, Knee Osteoarthritis
Keywords
Running, Gait Retraining, Return to Run, ACLR, Loading

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pre-test, post-test, single-blind randomized controlled trial study design
Masking
Outcomes Assessor
Masking Description
The outcomes assessors will be blind to treatment group.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic Intervention
Other Intervention Name(s)
Gait Retraining
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) During Running Pain
Description
VAS, measures self-reported pain, scored on a 0-10 scale with 0 being no pain and 10 being worst pain imaginable.
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)
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Subjective Knee Evaluation Form
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)
Secondary Outcome Measure Information:
Title
University of Wisconsin Running and Recovery Index (UWRI)
Description
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.
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)
Title
CPII Serum Biomarker Concentration
Description
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
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)
Title
C1 Serum Biomarker Concentration
Description
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
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)
Title
2C Serum Biomarker Concentration
Description
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
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)
Title
C2C Serum Biomarker Concentration
Description
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
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)
Title
CTX-1 Serum Biomarker Concentration
Description
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
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)
Title
NTX Serum Biomarker Concentration
Description
Blood specimen biomarker associated with knee osteoarthritis and cartilage/bone turnover.
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)
Title
Average Vertical Loading Rate (AVLR)
Description
A vertical ground reaction force measure that indicates how quickly force is being applied to the body.
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)
Other Pre-specified Outcome Measures:
Title
Patient Specific Functional Scale (PSFS)
Description
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).
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)
Title
Single Assessment Numeric Evaluation (SANE)
Description
SANE, scored on a 0-100% scale with 100% equaling completion of function
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)
Title
Peak Vertical Ground Reaction Force
Description
A vertical ground reaction force measure that indicates how the peak force applied to the body.
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)
Title
Braking Force
Description
A vertical ground reaction force measure that indicates the amount of anterior force applied to the body.
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)
Title
Vertical Center of Mass Displacement
Description
The difference between the highest vertical and lowest vertical point achieved during a running stride.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin M Miller, MS, ABD
Phone
845-987-0029
Email
erin.florkiewicz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Crowell, DSc
Phone
845-938-3067
Email
michaelcrowell99@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin M Miller, MS, ABD
Organizational Affiliation
Keller Army Community Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keller Army Community Hospital
City
West Point
State/Province
New York
ZIP/Postal Code
10996
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin M Miller, MS, ABD
Phone
845-987-0029
Email
erin.florkiewicz@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael Crowell, DSc
Phone
845-938-3067
Email
michaelcrowell99@gmail.com
First Name & Middle Initial & Last Name & Degree
Erin M Miller, MS,ABD
First Name & Middle Initial & Last Name & Degree
Michael Crowell, DSc
First Name & Middle Initial & Last Name & Degree
Donald Goss, PhD
First Name & Middle Initial & Last Name & Degree
John Mason, DSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Gait Retraining Enhances Athletes' Technique

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