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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Walking shoe with a anterior posterior rocker sole.
Dynamic carbon fiber ankle brace.
Standard walking shoe (control shoe) with no rocker sole.
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Daily Step Count (# Steps)
The daily step count of a participant as measured by a body worn pedometer.
Time frame: Three weeks
Ankle Joint Range of Motion (Degrees)
Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan
Time frame: Three weeks
Self-selected Walking Speed
Self-selected walking speed as measured with a stop watch when walking a fixed distance.
Time frame: Three weeks
Qualitative Assessment of Patient Device Wearing
Would you continue to wear the device if you were not part of the study? Why/why not?
Time frame: Three weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
Self reported capability of physical function Min: 0 Max: 100 A higher score indicates better physical function
Time frame: three weeks
Fast Walking Speed
Fast walking speed as measured with a stop watch when walking a fixed distance.
Time frame: Three weeks
Timed-up-and-go
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.
Time frame: Three weeks
Qualitative Assessment of Patient Satisfaction With the Device
Do you like the device? Why/why not?
Time frame: Three weeks
Qualitative Assessment of Device Preference
Do you have a preference to one of the treatments? Which one? Why/why not?
Time frame: Three Months
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Self reported consequences of pain on relevant aspects of one's life. Min:0 Max: 100 A higher score indicates more pain interference
Time frame: three weeks
Foot and Ankle Ability Measure (FAAM)
American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions. Min:0 Max: 100 Higher= better
Time frame: three weeks
Numeric Pain Rating Scale
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
Time frame: three weeks
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