Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions

This study involves the use of a newly designed shoe device for knee arthritis patients that
may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate
knee pain and function in healthy participants with a history of medial knee arthritis.

The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's
walking gait and balance over a single day; and 2. how using the shoe device over the course
of a 12-week period will affect a person's walking gait and balance.

Inclusion Criteria:

- Chronic, OA-related knee pain

- Diagnosis of medial compartment knee OA (unilateral or bilateral)

- Moderate pain of ≥4 out of 10 points while performing a weight-bearing activity

- Kellgren and Lawrence score of 2, 3, or 4 evidenced on routine, standard-of-care x-ray
within the last 2 years prior to enrollment

- Able to walk unassisted for at least 10 minutes at a time

- Wear a Women's shoe size of 6.5 to 13 or a Men's shoe size of 5 to 12.

Exclusion Criteria:

- Patients suffering from acute septic or inflammatory arthritis

- Unstable cardiovascular, orthopaedic, or neurological conditions, uncontrolled
diabetes, or any condition that would preclude exercise in moderate duration, moderate
workload trials

- Received a corticosteroid injection or invasive procedures within prior 6 months of
the study

- History of avascular necrosis in the knee

- History of knee buckling

- Joint replacement in any lower extremity joint that has not optimally recovered (e.g.
still causes significant pain or affects mobility) as determined by the PI.

- Experienced more than 3 falls within the last year

- Currently using any knee brace on a regular basis for the knee pain, with the
exception of basic knee sleeves

- Pathological osteoporotic fracture

- Severe symptomatic degenerative arthritis in lower limb joints other than the knees

- Severe back pain, prior spinal fusion or spinal deformity that would affect gait

- Major cardiac or pulmonary conditions and any orthopedic limitation that precludes
their ability to independently walk for 10 minutes or longer

- Knee flexion contracture greater than 15°

- Knee flexion of less than 90°

- Any major injury to either knee within the prior 12 months

- Currently enrolled in a supervised physical therapy program