Saving Life and Limb: FES for the Elderly With PAD

Phase 1

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: FES (Gait MyoElectric Stimulator)

• Registration Number: NCT02384980
• Lead Sponsor: MultiCare Health System Research Institute

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FES + Walk Group	FES (Gait MyoElectric Stimulator)	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MultiCare Health System; 🇺🇸 Tacoma, Washington, United States