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

NCT03524729 | Completed Results

• 2 other identifiers: F2278-RRX002278
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis; Healthy Ankles

Keywords

Rocker bottom shoe; Ankle-foot orthosis; Ankle osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Daily Step Count (# Steps)

  The daily step count of a participant as measured by a body worn pedometer.

  Three weeks

Secondary Outcomes (11)

• Ankle Joint Range of Motion (Degrees)

  Three weeks

• Self-selected Walking Speed

  Three weeks

• Qualitative Assessment of Patient Device Wearing

  Three weeks

• Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function

  three weeks

• Fast Walking Speed

  Three weeks

Study Arms (2)

Ankle osteoarthritis patients

ACTIVE COMPARATOR

Ambulatory adult patients (18+) with ankle osteoarthritis.

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

Healthy control subjects

OTHER

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

Device: Standard walking shoe

Interventions

Rocker bottom shoe DEVICE

Walking shoe with a anterior posterior rocker sole.

Ankle osteoarthritis patients

Ankle foot orthosis DEVICE

Dynamic carbon fiber ankle brace.

Ankle osteoarthritis patients

Standard walking shoe DEVICE

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

Ankle osteoarthritis patients; Healthy control subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For osteoarthritis patients:
• radiographic evidence of tibiotalar osteoarthritis
• ambulatory
• For healthy controls:
• ambulatory
• aged 18 or older

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Seattle, Washington, 98108, United States

Location

Results Point of Contact

• Title: Dr. Sangeorzan
• Organization: VA

bruce.sangeorzan@va.gov

206-516-3261

Study Officials

• Bruce J. Sangeorzan, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The osteoarthritis participants will wear the control shoe, rocker bottom shoe, and AFO for multiple weeks each. The order of the treatments (control shoe, rocker bottom shoe, and AFO) will be randomize. The control group will only wear the control shoe.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: May 15, 2018
• Study Start: January 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 15, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be posted ad-hoc on an ongoing basis.
• Access Criteria: Once posted, the data is available to the public.

Locations

US (1)