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

Study Overview
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Brief Summary
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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.

Official Title
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Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Device: Active feedback gait retraining


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait retraining<br>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. | Device: Active feedback gait retraining<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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