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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ankle Osteoarthritis; Healthy Ankles
• Intervention / Treatment: Device: Rocker bottom shoe; Device: Ankle foot orthosis; Device: Standard walking shoe

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ankle osteoarthritis patients; Ambulatory adult patients (18+) with ankle osteoarthritis.	Device: Rocker bottom shoe; Walking shoe with a anterior posterior rocker sole.; Device: Ankle foot orthosis; Dynamic carbon fiber ankle brace.; Device: Standard walking shoe; Standard walking shoe (control shoe) with no rocker sole.
Other: Healthy control subjects; Ambulatory adults (18+) with no known ankle osteoarthritis.	Device: Standard walking shoe; Standard walking shoe (control shoe) with no rocker sole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily step count (# steps)	The daily step count of a participant as measured by a body worn pedometer.	Three weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle joint range of motion (degrees)	Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan	Three weeks
Self-selected walking speed	Self-selected walking speed as measured with a stop watch when walking a fixed distance.	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?	Three weeks
PROMIS physical function	Self reported capability of physical function	three weeks
PROMIS pain interference	Self reported consequences of pain on relevant aspects of one's life.	Three weeks
Foot and ankle Mobility measure FAAM	American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions.	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.	Three weeks
Fast walking speed	Fast walking speed as measured with a stop watch when walking a fixed distance.	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.	Three weeks
Qualitative assessment of patient satisfaction with the device	Do you like the device? Why/why not?	Three weeks
Qualitative assessment of device preference	Do you have a preference to one of the treatments? Which one? Why/why not?	Three Months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Bruce J. Sangeorzan, MD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Ankle-foot orthosis; Rocker bottom shoe; Ankle osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: F2278-R; RX002278 (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All individual participant data collected will be de-identified and placed in publically accessible online data repositories.
• IPD Sharing Time Frame: Data will be posted ad-hoc on an ongoing basis.
• IPD Sharing Access Criteria: Once posted, the data is available to the public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No