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 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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Ankle foot orthosis; Other: Control/standard of care

Detailed Description

Peripheral artery disease (PAD) is a common cardiovascular disease manifesting from atherosclerotic blockages in the arteries of the legs. The most prevalent symptom of PAD is intermittent claudication, defined as pain or discomfort in the legs that is produced by physical activity and is relieved only through rest. PAD results in significant functional limitations such as slower walking velocity and an overall sedentary lifestyle. Prior research has documented significant deficits in gait biomechanics; specifically, an inability of the ankle plantar flexors to generate normal torque and power. Furthermore, insufficient blood flow was not found to be the only mechanism contributing to gait dysfunction in patients with PAD, but the affected muscle also demonstrates a myopathy that prevents normal leg function in these patients. Thus, treatment must consider muscular function and hemodynamics to improve function and increase activity levels. Supervised treadmill walking exercise is an effective treatment for increasing the distances patients with PAD can walk. However, there is a critical treatment gap for individuals whose disease presentations warrant a non--operative treatment plan but lack the motivation, time, access and monetary resources for supervised therapy. An ankle--foot orthosis (AFO) to offset ankle plantar flexor torque and power deficiency is a novel approach to increase the walking distances and physical activity levels in those with PAD. Made of a carbon-- composite material, AFOs are adjustable, affordable and could be prescribed and worn long--term to overcome the reduced propulsion and improve walking economy. The spring--like properties of carbon--composite AFOs allow energy storage at weight acceptance and return at the point of toe off, when the ankle plantar flexors are supposed to propel into the next step. Improvements in ankle kinetics and angular momentum have been reported by using an AFO with stroke, and other neuromuscular disorders affecting the legs. However, AFOs are typically worn for foot drop, and have never been implemented in patients with PAD to improve forward propulsion. Pilot work has shown that walking with an AFO instantly increases the initial and absolute walking distances in patients with PAD as much as pharmacotherapy for six months. An AFO addresses both the myopathy and low blood flow problems associated with claudication. Mechanical force from the AFO compensates for the insufficient propulsion force of the myopathic gastrocnemius muscles, while at the same time decreasing blood flow demand and muscular stress effects of ischemia. Thus an AFO allows patients to walk longer without pain or walk the distance needed to complete daily activities with less stress to the affected leg, and may preserve/improve the overall health of the PAD limb by lowering oxygen demands to PAD muscle and effort induced ischemia and stress.

Hypothesis: An AFO improves walking performance in patients with PAD by reducing the energy cost of walking and these improvements can be seen from the first time the patient uses the AFO. Further, an AFO intervention improves walking performance by improving the muscular function of patients' affected legs.

Specific Aim 1: Test the hypothesis that from its first use an AFO produces improvements in walking performance of patients with PAD by decreasing the required muscle contribution and energy cost of walking.

Specific Aim 2: Test the hypothesis that using an AFO for three months leads to progressive improvements in walking performance, physical activity levels and quality of life of patients with PAD and that these improvements correlate with improvements in the morphometric measurements, oxygenation levels, and muscle strength and endurance characteristics of the affected legs. A crossover design will be used, in which half of subjects will complete a three--month control period before, and half after, the AFO intervention.

Specific Aim 3: To determine the feasibility of a three month AFO intervention by examining acceptability (satisfaction, intent to continue use), demand (actual use, perceived demand), implementation (degree of use, success or failure of use, factors affecting use), and practicality (effects, ability of participants to use AFO).

If the hypothesis is correct, the study will be the first to demonstrate that a simple, accessible AFO device can rapidly improve functional status and quality of life in patients with PAD immediately by decreasing the required muscular contribution and oxygen demands to PAD muscle. Additionally, Aim #2 will evaluate the long--term effects of wearing an AFO on functional status and quality of life. Aim #3 will help the investigative team ensure it is feasible to implement the AFO in our target population. Detailed measures of mechanisms related with walking performance, muscle contribution, physical activity, quality of life and how these mechanisms change after wearing the AFO for three months will provide the evidence required to implement an AFO therapy that will improve functional status and quality of life in individuals with PAD.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68105
      • Omaha VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ankle foot orthosis; 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.	Device: Ankle foot orthosis; Patients will wear an ankle foot orthosis at all times except when he/she is sleeping or bathing for three months.
Active Comparator: Control; Patients will be asked to follow the instructions from their doctor regarding risk factor management and exercise for three months.	Other: Control/standard of care; Patients will carry out with typical activities suggested by their physician for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum walking distance from the Gardner graded treadmill protocol.	Initial claudication distance and the absolute claudication distance from the progressive treadmill test	Three months after intervention with the ankle foot orthosis.

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Sara A Myers, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimated): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: mobility; biomechanics; ankle foot orthosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 0485-16-FB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes