Saving Life and Limb: FES for the Elderly With PAD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: FES (Gait MyoElectric Stimulator)


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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Walk Group<br>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. | |
| Experimental: FES + Walk Group<br>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. | Device: FES (Gait MyoElectric Stimulator)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent Claudication, Functional Electrical Stimulation