Clinical trial NCT03760380: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions
Official title: Pilot Study: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions on Knee Osteoarthritis Acutely and Over a 12 Week Period
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arthritis Knee
Keywords: osteoarthritis (OA)
gait modifying shoe
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Scientific Motion Technologies, Inc.
First posted: 2018-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1 All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset)

Phase 2 Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use.
Primary purpose: OTHER

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in NRS pain (Pain Numeric Rating Scale) score.
timeFrame: Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12
Secondary outcomes:
measure: Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
timeFrame: Baseline (Phase 2), Week 4, Week 8, Week 12
measure: Change in SF-36 disability score.
timeFrame: Baseline (Phase 2), Week 4, Week 8, Week 12
measure: Change in Timed Up & Go (TUG) Test score.
timeFrame: Baseline (Phase 2), Week 4, Week 8, Week 12
measure: Change in Stair Climb time score.
timeFrame: Baseline (Phase 2), Week 4, Week 8, Week 12
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Hari K Parvataneni
role: PRINCIPAL_INVESTIGATOR
References: