Gait Retraining Enhances Athletes' Technique

NCT03918681 | Terminated

• 1 other identifier: 19KACH001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injury; Knee Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• University of Wisconsin Running and Recovery Index (UWRI)

  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

  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

  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

  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

  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 Outcomes (5)

• Patient Specific Functional Scale (PSFS)

  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)

  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

  Change from Pre-Intervention (Initial) to Post-Intervention (up to 10 weeks). Change from Pre-Intervention (Initial) to Follow-Up (Up to 15 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Therapeutic Intervention OTHER

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.

Also known as: Gait Retraining

Intervention Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keller Army Community Hospital: lead
• Telemedicine & Advanced Technology Research Center: collaborator

Study Sites (1)

Keller Army Community Hospital

West Point, New York, 10996, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Erin M Miller, MS, ABD

  Keller Army Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors will be blind to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director & Associate Professor

Model Details: pre-test, post-test, single-blind randomized controlled trial study design

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: April 17, 2019
• Study Start: August 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)