Improving Ambulatory Community Access After Paralysis

Louis Stokes VA Medical Center6 enrolled

Overview

The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.

In a surgical procedure electrodes are inserted into muscles of the lower extremities to correct hip, knee and ankle function. The electrode leads are connected to an implanted pulse generator located in the abdomen. After a typical post-operative period of two to five days, the recipient will be discharged home for two to six weeks of moderate activity. Following a 6 week period of laboratory exercise and training, functional use of the neuroprosthesis will begin at home and in the community with follow-up evaluations at 1, 3, 6 and 12 months. Laboratory assessments include walking speed and distance, physiologic cost, muscle strength, measure of spasticity, and gait analysis with and without stimulation. A number of self-reporting instruments are administered to capture individual's participation, quality of life and various aspects of perceived community ambulation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Partial Paralysis Spinal Cord Injury Tetraplegia Quadriplegia

Interventions

IRS-8 (8 channel implanted receiver stimulator)DEVICE

Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * problems walking because of paralysis for more than 6 months * weak hip flexors and extensors or excessive tone * weak ankle dorsiflexors (muscles bringing the foot up) * weak plantar flexors (ankle muscles for push-off) * foot drop that is causing "dragging" or "catching" toes during walking * swinging the leg sideways or hiking the hip to clear affected leg during stepping * endurance to walk at least 10 ft with minimal assistance * hip extension range to neutral * hip flexion range greater or equal to 90 degrees * ankle range to neutral * sufficient upper extremity function to use a walking aid * muscles respond to electrical stimulation Exclusion Criteria: * cardiac arrythmias * demand pacemaker * pregnancy * Parkinson's disease * traumatic brain injury * autoimmune deficiency * uncontrolled diabetes * significant edema of the affected limb * active pressure ulcers or open wounds * sepsis or an active infection * severe osteoporosis * uncontrolled seizures * moderate depression

Locations (1)

Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis

Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without stimulation to determine if individuals are able to improve community ambulatory access with use of neuroprosthesis.

Time frame: up to 36 months

Secondary Outcomes

Feasibility of initiating a step with a trigger from an accelerometer incorporated in the external control unit to adjust to environmental circumstances and situations encountered in community ambulation

Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without accelerometer triggered stepping to determine if individuals are able to adjust to environmental circumstances and situations encountered in community ambulation.

Time frame: up to 36 months

Central Contacts

Lisa M Lombardo, MPT

CONTACT

216-791-3800 llombardo@fescenter.org

Data from ClinicalTrials.gov

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