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

Pilot Study: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions on Knee Osteoarthritis Acutely and Over a 12 Week Period

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 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