Improving Ambulatory Community Access After Paralysis

• The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  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.
  
  

• 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 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  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.
  
  

Device: IRS-8 (8 channel implanted receiver stimulator)
Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities
Other Names:
• Implanted pulse generator for ambulation
• Implanted FES system for lower extremities
• Implated FES system for ambulation
• FES system for walking
• Implanted neuroprosthesis for gait correction
• Gait correction in 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.