Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/24/2019 |
| Start Date: | January 1, 2019 |
| End Date: | June 1, 2022 |
| Contact: | Patrick Aubin, PhD MS BS |
| Email: | patrick.aubin@va.gov |
| Phone: | (206) 277-6310 |
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?
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.
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.
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.
Inclusion Criteria:
For osteoarthritis patients:
- radiographic evidence of tibiotalar osteoarthritis
- ambulatory
For healthy controls:
- ambulatory
- aged 18 or older
Exclusion Criteria:
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
We found this trial at
1
site
Seattle, Washington 98108
Principal Investigator: Bruce J. Sangeorzan, MD
Phone: 206-277-6310
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