Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
- Conditions
- Ankle OsteoarthritisHealthy Ankles
- Interventions
- Device: Rocker bottom shoeDevice: Ankle foot orthosisDevice: Standard walking shoe
- Registration Number
- NCT03524729
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 11
For osteoarthritis patients:
- radiographic evidence of tibiotalar osteoarthritis
- ambulatory
For healthy controls:
- ambulatory
- aged 18 or older
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ankle osteoarthritis patients Standard walking shoe Ambulatory adult patients (18+) with ankle osteoarthritis. Ankle osteoarthritis patients Rocker bottom shoe Ambulatory adult patients (18+) with ankle osteoarthritis. Healthy control subjects Standard walking shoe Ambulatory adults (18+) with no known ankle osteoarthritis. Ankle osteoarthritis patients Ankle foot orthosis Ambulatory adult patients (18+) with ankle osteoarthritis.
- Primary Outcome Measures
Name Time Method Daily Step Count (# Steps) Three weeks The daily step count of a participant as measured by a body worn pedometer.
- Secondary Outcome Measures
Name Time Method Ankle Joint Range of Motion (Degrees) Three weeks Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan
Self-selected Walking Speed Three weeks Self-selected walking speed as measured with a stop watch when walking a fixed distance.
Qualitative Assessment of Patient Device Wearing Three weeks Would you continue to wear the device if you were not part of the study? Why/why not?
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function three weeks Self reported capability of physical function Min: 0 Max: 100 A higher score indicates better physical function
Fast Walking Speed Three weeks Fast walking speed as measured with a stop watch when walking a fixed distance.
Timed-up-and-go Three weeks Self-selected walking speed get out of a chair, walk to a line, turn around, walk back to the chair and sit down as measured with a stop watch.
Qualitative Assessment of Patient Satisfaction With the Device Three weeks Do you like the device? Why/why not?
Qualitative Assessment of Device Preference Three Months Do you have a preference to one of the treatments? Which one? Why/why not?
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference three weeks Self reported consequences of pain on relevant aspects of one's life.
Min:0 Max: 100 A higher score indicates more pain interferenceFoot and Ankle Ability Measure (FAAM) three weeks American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions.
Min:0 Max: 100 Higher= betterNumeric Pain Rating Scale three weeks The Numeric Pain Rating Scale is a measure of pain intensity in adults in which the respondent selects a whole number (0-10) that best reflects the intensity of her / his pain. The scale will be administered verbally.
scale of 1-10 higher= worse
Trial Locations
- Locations (1)
VA Puget Sound Health Care System Seattle Division, Seattle, WA
🇺🇸Seattle, Washington, United States