Performance of an intramuscular electrode during functional neuromuscular stimulation for gait training post stroke.

The goal of rehabilitation for stroke patients in this research was to improve the volitional coordination of the swing phase and stance phases of gait. Functional neuromuscular stimulation (FNS) is a promising rehabilitation tool for restoring motor control. For our gait training protocols, FNS systems with surface electrodes were impractical. For the rehabilitation protocols that we defined, available implantable electrode designs did not meet desired criteria regarding fracture rate, invasiveness of placement procedures, and maintenance of position at the motor point. The criteria for the new intramuscular (IM) electrode design included minimally invasive electrode placement technique, accurate placement of electrodes, good muscle selectivity, consistency of muscle activation, good position maintenance of the electrode at the motor point, comfortable stimulus, and practical donning time for the system. A percutaneous electrode was designed for placement beneath the skin at the motor point of seven paralyzed or paretic muscles in the lower limb. A single-helical coil lead, a double-helical coil electrode, and fine wire barbs were design features that enhanced the anchoring capability of the electrode. A polypropylene core enhanced electrode durability. Implantation tools were custom-designed to enable accurate electrode placement without incision. We studied 17 subjects with a total of 124 electrodes. With the use of IM electrodes, FNS was provided for 1,413.8 electrode months. During this time, no instances of infection occurred. The measure of electrode integrity showed a 99% electrode survival rate. Throughout the treatment protocols, 93% of the electrodes delivered a good muscle response; 7% (nine electrodes) moved from the motor point and delivered a poor muscle response during the treatment protocol. Anchoring performance was higher for electrodes implanted in muscles that moved the hip (96.0%) and ankle joints (97.45%) compared with electrodes implanted in muscles that moved the knee joint (88.5%). Ninety-seven percent of the electrodes delivered a comfortable stimulus. Three percent delivered a stimulus that was uncomfortable at therapeutic levels and therefore were not used. We achieved gains in subject impairment and disability measures. The system proved to be practical for use in both clinical and home environments.