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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.