Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk

Overview

The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients.

Full Title of Study: “Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Interventions

  • Device: Active feedback gait retraining
    • The device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity.

Arms, Groups and Cohorts

  • Experimental: Gait retraining
    • Eight weeks of active-feedback gait retraining. The gait retraining device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity.

Clinical Trial Outcome Measures

Primary Measures

  • Knee Adduction Moment
    • Time Frame: Change from baseline to immediately after 8 weeks of retraining
    • Knee Joint Loading (%Bw*Ht) will be assessed at baseline and immediately after gait retraining

Secondary Measures

  • Medial knee compartment qMRI
    • Time Frame: Change from baseline to 6 months after retraining
    • Changes to quantitative MRI measures at 6 months after retraining will be correlated with changes to joint loading
  • Knee Adduction Moment
    • Time Frame: Change from baseline to 3 months after retraining
    • Knee Joint Loading (%Bw*Ht)
  • Knee Adduction Moment
    • Time Frame: Change from baseline to 6 months after retraining
    • Knee Joint Loading (%Bw*Ht)
  • Serum inflammatory markers
    • Time Frame: Change from baseline to immediately after 8 weeks of retraining
    • Changes to serum inflammatory markers immediately after the end of training from baseline will be correlated with changes to joint loading

Participating in This Clinical Trial

Inclusion Criteria

  • age 18-40 years – history of primary ACLR with or without meniscal repair – full weight-bearing status – neutral to varus knee alignment – plans to remain in the area for at least 8 months. Exclusion Criteria:

  • Kellgren-Lawrence (KL) radiographic grade > 2 – additional injury or surgery to the involved knee – BMI >30 kg/m2 – use of walking, orthopedic, or prosthetic assistive device – pregnancy – inability to have MRI

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Palo Alto Health Care System
  • Collaborator
    • United States Department of Defense
  • Provider of Information About this Clinical Study
    • Principal Investigator: Constance Chu, MD, Study Principal Investigator – VA Palo Alto Health Care System
  • Overall Official(s)
    • Constance Chu, MD, Principal Investigator, VAPAHCS and Stanford University
  • Overall Contact(s)
    • Jennifer Hledik, PhD, 650-493-5000, jerhart@stanford.edu

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