NCT02384980

Saving Life and Limb: FES for the Elderly With PAD

Saving Life and Limb: Functional Electrical Stimulation for the Elderly With Peripheral Artery Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: MultiCare Health System Research Institute · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will take the first step to improve public health for millions of Americans with Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The investigators will assess a proof of concept, home administered, functional electrical stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.

Detailed description

This study will evaluate an innovative approach to reduce the debilitating symptoms of peripheral arterial disease (PAD) and ischemic pain during walking (intermittent claudication) by using a new Functional Electrical Stimulation (FES) system. The investigators hypothesize that combining the FES and walking one hour/day (FES+Walk) will significantly reduce pain during walking, improve locomotion, and enhance quality of life when compared to walking one hour/day (Walk) alone after 8 weeks of intervention.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	FES (Gait MyoElectric Stimulator)	Functional Electrical Stimulation (FES) will be tested in a group of peripheral arterial disease patients using the Gait MyoElectric Stimulator. The FES device will be applied to the calf and shin muscles on both of the patients legs.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2015-03-10
• Last updated: 2016-08-16

Locations

1 site across 1 country: United States