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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG048001-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walk Group | No Intervention | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Patients who:
Exclusion Criteria:
Patients who:
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| Name | Affiliation | Role |
|---|---|---|
| David G. Embrey, PT, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MultiCare Health System | Tacoma | Washington | 98405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28595744 | Derived | Embrey DG, Alon G, Brandsma BA, Vladimir F, Silva A, Pflugeisen BM, Amoroso PJ. Functional electrical stimulation improves quality of life by reducing intermittent claudication. Int J Cardiol. 2017 Sep 15;243:454-459. doi: 10.1016/j.ijcard.2017.05.097. Epub 2017 Jun 2. |
| Label | URL |
|---|---|
| An introductory article about this NIH funded study and benefits of functional electrical stimulation | View source |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| 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) |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |