Considerations for Implementation of an Ankle-Foot Orthosis to Improve Mobility in Peripheral Artery Disease.

Objective: To explore the perceptions of wearing an ankle-foot orthosis (AFO) in patients with peripheral artery disease (PAD) who did and did not adopt the AFO intervention. This follows a clinical trial of the effectiveness of an AFO in improving walking distances for patients with PAD-related claudication.

Design: A randomized crossover trial of standard of care and an AFO for 3 months. Semistructured interviews were conducted 1.5 months into the AFO intervention to understand acceptability, demand, implementation, and practicality. Data were analyzed using a summative content analysis approach.

Setting: Vascular surgery clinic and biomechanics research laboratory.

Participants: Patients (N=15; male, 100%; age, 71.9±.6.7y; body mass index [calculated as weight in kilograms divided by height in meters squared], 29.0±.5.5; ankle brachial index: AFO intervention withdrawal, 0.543; AFO intervention completion, 0.740) with claudication completed the study, and 6 withdrew prior to intervention completion.

Interventions: A certified orthotist fit participants with an AFO that was worn for 3 months.

Main Outcome Measures: Qualitative analysis of the semistructured interviews.

Results: Key differences were reported between AFO intervention completion and AFO intervention withdrawal. Six of 14 of AFO intervention completion participants described their initial reactions to the AFO as negative vs 3 of 6 AFO intervention withdrawal participants. Only 5 of 15 AFO intervention completion participants reported minimal use of the AFO compared with 5 of 6 AFO intervention withdrawal participants. The AFO intervention withdrawal group reported higher levels of physical discomfort with the use of the AFO (4/6 vs 7/15) and preexisting health issues becoming a barrier to the use of the AFO (3/6 vs 5/15). Positive aspects reported included ease in standing and walking for AFO intervention withdrawal (4/6) and AFO intervention completion groups (13/15) as well as walking straighter and longer with less pain for AFO intervention withdrawal (3/6) and AFO intervention completion groups (9/15).

Conclusions: Patients withdrawing prior to completion of AFO intervention tended to have more negative perceptions, more comorbidities, and more physical discomfort than those completing the intervention. Both groups reported positive aspects of the AFO. Implementation studies are needed to address barriers to AFO adoption.