Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients

NCT ID: NCT03524729

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-06-15

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.

Conditions

Ankle Osteoarthritis; Healthy Ankles

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ankle osteoarthritis patients

Ambulatory adult patients (18+) with ankle osteoarthritis.

Group Type: ACTIVE_COMPARATOR

Rocker bottom shoe

Intervention Type: DEVICE

Walking shoe with a anterior posterior rocker sole.

Ankle foot orthosis

Intervention Type: DEVICE

Dynamic carbon fiber ankle brace.

Standard walking shoe

Intervention Type: DEVICE

Standard walking shoe (control shoe) with no rocker sole.

Healthy control subjects

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

Group Type: OTHER

Standard walking shoe

Intervention Type: DEVICE

Standard walking shoe (control shoe) with no rocker sole.

Interventions

Rocker bottom shoe

Walking shoe with a anterior posterior rocker sole.

Intervention Type: DEVICE

Ankle foot orthosis

Dynamic carbon fiber ankle brace.

Intervention Type: DEVICE

Standard walking shoe

Standard walking shoe (control shoe) with no rocker sole.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce J. Sangeorzan, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Locations

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RX002278

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

F2278-R

Identifier Type: -

Identifier Source: org_study_id