Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?
试验速览
- 阶段
- 不适用
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Daily Step Count (# Steps)
研究概览
简要总结
Ankle osteoarthritis (OA) is a painful, progressive condition that can severely limit physical activity and reduce quality of life. Rocker bottom (RB) shoes and ankle-foot orthoses (AFOs) are commonly used as non-surgical treatments for ankle OA. RB shoes have a curved sole in the toe to heel direction that may alleviate joint pain by reducing ankle range of motion (ROM). Similarly, AFOs may reduce joint motion by securing the foot and ankle within the ankle-foot orthosis (AFO) frame. This study aims to determine the ability of RB shoes and AFOs to improve mobility, by relieving pain and reducing joint ROM.
详细描述
The investigators' objective is to compare two non-surgical treatments (RB shoes and Toeoff brand AFOs) in OA subjects by measuring their mobility and pain during and after a multi-week trial period. The investigators will use a biplane fluoroscopy system to measure foot joint motion for each condition (RB shoe, AFO, control shoe). This will yield clinical and biomechanical measures of the effect of each orthotic on mobility, pain, and joint ROM in an ankle OA population. The investigators will also compare the clinical and biomechanics outcomes of OA subjects to those of control subjects. This information will provide evidence to support clinical decision making.
Aim 1: Compare the daily sep count, self-selected walking speed, clinical outcome measures (PROMIS surveys) of a control shoe, RB shoe, and AFO worn over a multi-week trial period.
Aim 2: Evaluate the effect of a control shoe, RB shoe, and AFO on the foot and ankle joints range of motion.
Aim 3: Compare the ankle OA clinical and biomechanical outcome measures for the control shoe, RB shoe, and AFO to a healthy control group wearing control shoes.
The efficacy of conservative treatments such as RB shoes and AFOs for managing OA pain and discomfort is not well supported by clinical evidence. By using biplane fluoroscopy along with validated clinical measures of pain and mobility, this study will elucidate the mechanism by which RB shoes and AFOs biomechanically alter foot and ankle function. Identifying beneficial treatment strategies for people with ankle OA will help them regain their mobility and improve their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For osteoarthritis patients:
- •radiographic evidence of tibiotalar osteoarthritis
- •ambulatory
- •For healthy controls:
- •ambulatory
- •aged 18 or older
排除标准
- •For osteoarthritis patients and healthy controls:
- •subtalar joint arthritis
- •plans for surgical treatment of ankle osteoarthritis within the next 4 months
- •surgical, neurological, metabolic, or lower limb musculoskeletal problem that would impair study measures
- •inability to walk unassisted during short, repeated walking trials
- •rheumatoid arthritis
- •inadequate cognitive or language function to consent or to participate
- •no phone number or stable mailing address
结局指标
主要结局
Daily Step Count (# Steps)
时间窗: Three weeks
The daily step count of a participant as measured by a body worn pedometer.
次要结局
- Ankle Joint Range of Motion (Degrees)(Three weeks)
- Self-selected Walking Speed(Three weeks)
- Qualitative Assessment of Patient Device Wearing(Three weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function(three weeks)
- Fast Walking Speed(Three weeks)
- Timed-up-and-go(Three weeks)
- Qualitative Assessment of Patient Satisfaction With the Device(Three weeks)
- Qualitative Assessment of Device Preference(Three Months)
- Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference(three weeks)
- Foot and Ankle Ability Measure (FAAM)(three weeks)
- Numeric Pain Rating Scale(three weeks)