Saving Life and Limb: FES for the Elderly With PAD

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384980
• Other study ID #: 14.12
• Secondary ID: 1R21AG048001-01
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2014
• Last updated: August 15, 2016
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: MultiCare Health System Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• FES (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.

Locations

Country	Name	City	State
United States	MultiCare Health System	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
MultiCare Health System Research Institute	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

•   An introductory article about this NIH funded study and benefits of functional electrical stimulation