Saving Life and Limb: FES for the Elderly With PAD

NCT02384980 | Completed Phase 1 DMC

• 2 other identifiers: 14.121R21AG048001-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Intermittent Claudication; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (2)

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.

Device: FES (Gait MyoElectric Stimulator)

Interventions

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.

FES + Walk Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MultiCare Health System Research Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• 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.

  PMID: 28595744 DERIVED

Related Links

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

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David G. Embrey, PT, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: March 10, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

US (1)