Back to resultsSaving Life and Limb: FES for the Elderly With PAD
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FES (Gait MyoElectric Stimulator)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Intermittent Claudication, Functional Electrical Stimulation
Eligibility Criteria
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
Sites / Locations
- MultiCare Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Walk Group
FES + Walk Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02384980
First Posted
November 10, 2014
Last Updated
August 15, 2016
Sponsor
MultiCare Health System Research Institute
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02384980
Brief Title
Saving Life and Limb: FES for the Elderly With PAD
Official Title
Saving Life and Limb: Functional Electrical Stimulation for the Elderly With Peripheral Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MultiCare Health System Research Institute
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Intermittent Claudication, Functional Electrical Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walk Group
Arm Type
No Intervention
Arm 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.
Arm Title
FES + Walk Group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
FES (Gait MyoElectric Stimulator)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from initial assessment, baseline, end of intervention and final assessment using the Perceived Pain Intensity Scale
Description
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)
Title
Change from initial assessment, baseline, end of intervention and final assessment using the 6 Minute Walk Test
Description
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)
Title
Change from initial assessment, baseline, end of intervention and final assessment using the Peripheral Artery Disease Quality of Life Questionnaire
Description
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 Outcome Measure Information:
Title
Change from initial assessment, baseline, end of intervention and final assessment using the Timed-Up-and-Go test
Description
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)
Title
Change from initial assessment, baseline, end of intervention and final assessment using the Intermittent Claudication Questionnaire (ICQ)
Description
We will record and measure the questionnaire score 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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G. Embrey, PT, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28595744
Citation
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.
Results Reference
derived
Links:
URL
http://www.multicare.org/news/multicare-researcher-wins-nih-grant/
Description
An introductory article about this NIH funded study and benefits of functional electrical stimulation
Learn more about this trial
Saving Life and Limb: FES for the Elderly With PAD
We'll reach out to this number within 24 hrs