Status:
WITHDRAWN
Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Scientific Motion Technologies, Inc.
Conditions:
Arthritis Knee
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03760380
Start Date
April 16 2019
End Date
November 10 2020
Last Update
November 12 2020
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