Peripheral Arterial Disease
Conditions
Keywords
Intermittent Claudication, Functional Electrical Stimulation
Brief summary
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
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.
Interventions
DEVICEFES (Gait MyoElectric Stimulator)
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.
Sponsors
National Institute on Aging (NIA)
MultiCare Health System Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from initial assessment, baseline, end of intervention and final assessment using the Perceived Pain Intensity Scale | Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post-intervention) | We will measure the changes in pain scores from baseline to end of intervention and end of post-intervention |
| Change from initial assessment, baseline, end of intervention and final assessment using 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) | We will measure the changes in distance walked during the 6 minute walk test |
| Change from initial assessment, baseline, end of intervention and final assessment using the Peripheral Artery Disease Quality of Life Questionnaire | Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention) | We will record and measure the changes in questionnaire scores from baseline to end of intervention and end of post-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from initial assessment, baseline, end of intervention and final assessment using the Timed-Up-and-Go test | Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention) | We will measure the time (seconds) to complete the test from baseline to end of intervention and end of post-intervention |
| Change from initial assessment, baseline, end of intervention and final assessment using the Intermittent Claudication Questionnaire (ICQ) | Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention) | We will record and measure the questionnaire score from baseline to end of intervention and end of post-intervention |
Countries
United States
Outcome results
None listed