Saving Life and Limb: FES for the Elderly With PAD

MultiCare Health System Research Institute43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

FES (Gait MyoElectric Stimulator)DEVICE

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

MultiCare Health System

Tacoma, Washington, United States

Outcomes

Primary Outcomes

Change from initial assessment, baseline, end of intervention and final assessment using the Perceived Pain Intensity Scale

We will measure the changes in pain scores from baseline to end of intervention and end of post-intervention

Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post-intervention)

Change from initial assessment, baseline, end of intervention and final assessment using the 6 Minute Walk Test

We will measure the changes in distance walked during the 6 minute walk test

Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention, and final assessment at 16 weeks (8 weeks post- intervention)

Change from initial assessment, baseline, end of intervention and final assessment using the Peripheral Artery Disease Quality of Life Questionnaire

We will record and measure the changes in questionnaire scores from baseline to end of intervention and end of post-intervention

Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)

Secondary Outcomes

Change from initial assessment, baseline, end of intervention and final assessment using the Timed-Up-and-Go test

We will measure the time (seconds) to complete the test from baseline to end of intervention and end of post-intervention

Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)

Change from initial assessment, baseline, end of intervention and final assessment using the Intermittent Claudication Questionnaire (ICQ)

We will record and measure the questionnaire score from baseline to end of intervention and end of post-intervention

Data from ClinicalTrials.gov

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