Calf claudication is a significant cause of walking limitation for patients with peripheral artery disease (PAD). Ankle-foot orthoses (AFO) are leg devices that can reduce the physical demands on the calf muscles during ambulation. The purpose of this study was to determine the efficacy of AFO on walking ability in patients with PAD. This was an open-label, interventional trial including 15 patients with calf claudication who were fit with AFO. Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum. Comparison of peak walking time (PWT) at baseline versus 12 weeks was the primary outcome. A secondary outcome was claudication onset time (COT) assessed during graded treadmill tests. Change in walking ability of AFO group patients was also compared to outcomes from a historical PAD control group (n = 10) who received upfront advice to walk at home. Patients in the AFO group significantly improved their walking ability from baseline to 12 weeks (mean ± SD) (PWT: 7.8 ± 5.1 to 9.3 ± 5.4 min, p = 0.049; COT: 3.0 ± 2.3 to 4.8 ± 2.7 min, p = 0.01). Change in PWT for AFO group patients when tested without using the devices was not significantly greater compared to historical controls (+1.4 ± 2.4 vs +0.1 ± 2.6 min, p = 0.16) but it was for COT (+1.8 ± 2.5 vs −0.6 ± 2.2 min, p = 0.02). This study found that AFO used during community-based walking improved the primary outcome of PWT in patients with PAD. Further, using AFO delayed claudication onset, indicating patients may be able to increase their walking activity. Large-scale, randomized controlled trials are needed to further explore the use of AFO for PAD. ClinicalTrials.gov identifier: NCT02280200.
Bibliographical noteFunding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: the study was funded by the National Institutes of Health (NIH), National Institute of General Medical Sciences, Mountain West Clinical Translational Research – Infrastructure Network under award U54GM104944. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
© The Author(s) 2019.
Copyright 2019 Elsevier B.V., All rights reserved.
- 6-minute walk test
- ankle-foot orthoses
- community-based exercise
- patient-reported outcomes
- peripheral artery disease (PAD)