Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis

Completed · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

This study will determine whether an ankle foot orthosis (AFO) improves walking performance in participants 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 participants 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 to fit 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.

Key facts

Study ID: NCT02902211
Run by: University of Nebraska
People needed: 50
Starts: 2017-07-07
Expected to finish: 2023-06-30
Last updated by the study team: 2024-08-20

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

able to give written, informed consent
demonstrate positive history of chronic claudication
demonstrate exercise limiting claudication established by history and direct observation
have an ankle/brachial index < 0.90 at rest
have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks.

You may not qualify if…

rest pain or tissue loss due to PAD (Fontaine stage III and IV)2)
acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
walking capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

Where it is running

Omaha VA Medical Center — Omaha, Nebraska, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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