Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients (RB/AFO)

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Ankle Osteoarthritis; Healthy Ankles

Treatments: Device: Standard walking shoe; Device: Rocker bottom shoe; Device: Ankle foot orthosis

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03524729

RX002278 (Other Grant/Funding Number)

F2278-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Ankle osteoarthritis patients

Active Comparator group

Description:

Ambulatory adult patients (18+) with ankle osteoarthritis.

Treatment:

Device: Ankle foot orthosis

Device: Rocker bottom shoe

Device: Standard walking shoe

Healthy control subjects

Other group

Description:

Ambulatory adults (18+) with no known ankle osteoarthritis.

Treatment:

Device: Standard walking shoe