NCT02280200

Ankle-foot Orthoses for Peripheral Artery Disease

Efficacy of Ankle-Foot Orthoses on Walking Ability in Peripheral Artery Disease: The AFO for PAD Trial I

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).

Detailed description

The investigators will test the hypothesis that PAD patients using an AFO during a graded exercise test will demonstrate a greater PWT compared to PWT assessed without the use of an AFO. Secondary hypotheses include evaluation of the effect of an AFO on: 1) calf muscle function, 2) claudication onset time, 3) functional ability, 4) peak oxygen consumption, and 5) patient-reported outcomes. We will also examine the effects of the AFO on outcomes following 12 weeks of community walking.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	AFO to improve outcomes	Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-10-31
• Last updated: 2019-07-31
• Results posted: 2019-07-31

Locations

1 site across 1 country: United States