CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Rocker bottom shoe +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03524729
NCT03524729N/ACompleted

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

VA Office of Research and Development·interventional·Posted May 15, 2018·Updated Sep 19, 2024

In Brief

A clinical study evaluating Rocker bottom shoe, Ankle foot orthosis, and 1 other intervention for Ankle Osteoarthritis and Healthy Ankles. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 15, 2018
Enrollment StartJan 1, 2019
Primary CompletionJun 1, 2022
Study CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.1 years ago

Interventions

Rocker bottom shoedevice

Walking shoe with a anterior posterior rocker sole.

Ankle foot orthosisdevice

Dynamic carbon fiber ankle brace.

Standard walking shoedevice

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