Pilot Study: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions on Knee Osteoarthritis Acutely and Over a 12 Week Period
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in NRS pain (Pain Numeric Rating Scale) score.
研究概览
简要总结
This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in NRS pain (Pain Numeric Rating Scale) score.
时间窗: Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12
Participants selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as one can imagine" or "worst pain imaginable").
次要结局
- Change in SF-36 disability score.(Baseline (Phase 2), Week 4, Week 8, Week 12)
- Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score(Baseline (Phase 2), Week 4, Week 8, Week 12)
- Change in Stair Climb time score.(Baseline (Phase 2), Week 4, Week 8, Week 12)
- Change in Timed Up & Go (TUG) Test score.(Baseline (Phase 2), Week 4, Week 8, Week 12)