Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis

This study will determine whether an ankle foot orthosis (AFO) improves walking performance
in patients with PAD from its first use. Additionally, the study will test walking
performance after a three month AFO intervention and will examine the feasibility of this AFO
intervention.

Data for evaluations will be collected from 50 patients with PAD. Fifty healthy age-matched
controls will be participate in one baseline gait assessment for comparison purposes. Both
groups between 40-85 years old.

Interventions and Evaluations Biomechanics evaluations: Patients with PAD will complete a
biomechanics evaluation at baseline, following three months of control (standard of care),
and following three months of AFO intervention. The evaluation will include measurement of
walking distances, gait function, physical activity, quality of life, energy cost, muscle
morphometrics, muscle activity, muscle oxygenation, and muscle strength and endurance while
walking with and without the AFO. Healthy controls will be assessed during one baseline
collection only and their participation in the study will then be finished.

Feasibility interview: All patients with PAD will participate in feasibility interviews that
will assess acceptability, demand, implementation, and practicality. Interviews will occur
1.5 months and following completion of the AFO intervention (not the control arm).

AFO and Control (standard of care) Intervention: Patients will wear an off-the-shelf, carbon
composite AFO that is adjusted for them for three months. The patients will be asked to wear
the AFO at all times except when they are in bed or showering/bathing. The instructions given
to the patients about walking will be to follow the instructions from their doctor regarding
risk factor management and exercise. The intervention order will be randomized and all
subjects will participate in both arms.