Saving Life and Limb: FES for the Elderly With PAD

MultiCare Health System Research Institute

Status and phase: Completed; Phase 1

Conditions: Peripheral Arterial Disease

Treatments: Device: FES (Gait MyoElectric Stimulator)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02384980

1R21AG048001-01 (U.S. NIH Grant/Contract)

14.12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Walk Group

No Intervention group

Description:

This group of patients are part of the walk group. They will be encouraged to walk and will receive standard care, defined as conservative (non-surgical) management of signs and symptoms, including prescriptive medications to improve circulation and manage pain, determined by their attending physician on a case by case basis.

FES + Walk Group

Experimental group

Description:

This group of patients will participate in Functional Electrical Stimulation (FES) and exercise. This group will receive functional electrical stimulation as an intervention. The FES device will stimulate (activate) the calf and shin leg muscles of both legs while the patient is walking. This group will also receive standard care, defined as conservative (non-surgical) management of signs and symptoms, including prescriptive medications to improve circulation and manage pain, determined by their attending physician on a case by case basis.

Treatment:

Device: FES (Gait MyoElectric Stimulator)