Saving Life and Limb: FES for the Elderly With PAD
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 50 - 85 |
Updated: | 8/17/2016 |
Start Date: | September 2014 |
End Date: | May 2016 |
Saving Life and Limb: Functional Electrical Stimulation for the Elderly With Peripheral Artery Disease
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.
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.
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.
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.
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
We found this trial at
1
site
314 Martin Luther King Junior Way
Tacoma, Washington 98405
Tacoma, Washington 98405
(253) 403-5200
Principal Investigator: David G. Embrey, PT, PhD
Phone: 253-697-5255
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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