Improving Ambulatory Community Access After Paralysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Ambulatory Community Access After Paralysis

Conditions
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Stroke, Partial Paralysis, Spinal Cord Injury, Tetraplegia, Quadriplegia

Intervention / Treatment
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* Device: IRS-8 (8 channel implanted receiver stimulator)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures | Device: IRS-8 (8 channel implanted receiver stimulator)<br>* Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities<br>* Other names: Gait correction in partial paralysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, partial paralysis, gait correction, functional electrical stimulation, paraplegia, tetraplegia, spinal cord injury