Expired Study
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Tacoma, Washington 98405


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: Patients who: 1. Are ambulatory, community dwelling adults with evidence of PAD including ankle/brachial index ABI=0.4-0.9 2. Have symptom severity of Fontaine stage II-III 3. Have a score of 24 or higher on the Folstein Mini Mental test 4. Have visible muscle contraction of the plantar flexor (PF) and dorsiflexor (DF) muscles using FES Exclusion Criteria: Patients who: 1. Have an electronic implanted stimulator such as pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator 2. Are pregnant 3. Cannot walk without a walker or require human assistance to walk, 4. Present with arthritis or neurological damage resulting in paresis or paralysis of the lower extremity 5. Have skin lesion(s) on the legs where the FES is placed


NCT ID:

NCT02384980


Primary Contact:

Principal Investigator
David G. Embrey, PT, PhD
Principal Investigator


Backup Contact:

N/A


Location Contact:

Tacoma, Washington 98405
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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