The Case Western Reserve University hybrid gait orthosis.

Six individuals with paraplegia and injury levels from C-1 through T-12 participated in a study to evaluate the functional capabilities of a hybrid gait orthotic system. Subjects learned to use a custom-built reciprocal gait orthosis without stimulation and with electrical stimulation activating between 4 and 16 muscles. Outcomes were scored with standard physical therapy measures including the Tinetti test, a timed get up and go, Borg rating of perceived exertion, and the Functional Index Measure (FIM). Subjects have successfully accomplished sit to stand, stand to sit, and walking maneuvers measured for time, speed, and distance. Metabolic consumption was measured for walking in the light work region of 5.1 to 6.5 metabolic equivalents (METs) 1 MET = 3.5 ml of O2/kg/min with hybrid gait orthosis. Perceived exertion as measured with the Borg scale indicated that use of the bracing system with functional electrical stimulation was "easier" than without stimulation. Subjects using a hybrid system were able to walk up to 350 m at average speeds of 0.25 m/s. Walking speeds for 30- and 50-meter distances reached 0.45 m/s. Additionally, walking distances with stimulation were 2 times greater than those of non-stimulated reciprocal gait. FIM scores indicated that system users would become slightly more independent in mobility. Results were used to determine the most useful brace modifications for the next generation of Case Western Reserve University hybrid gait orthoses to allow an expanded function that will include stair climbing and side stepping.

Implanted functional electrical stimulation system for mobility in paraplegia: a follow-up case report.

A 16-channel functional electrical stimulation (FES) system has been implanted in a person with T10 paraplegia for over a year. The system consists of two eight-channel radio frequency controlled receiver-stimulators delivering stimuli through a network of 14 epimysial and two intramuscular electrodes. Using this system and a walker for support, the subject was able to stand up for 8 min and walk regularly for 20 m. The standing duration was limited by arm fatigue since upper extremities supported an average of 25% of body weight. This was due to suboptimal hip extension and some undesired recruitment of rectus femoris and sartorius with stimulation of quadriceps electrodes. The left quadriceps exhibited rapid fatigue that limited walking distance and duration. The metabolic energy requirements were well within the aerobic limits of the sedentary paraplegic population. At one-year follow-up evaluation all electrodes are functional except one intramuscular electrode. The implant caused no adverse physiological effects and the individual reported health benefits such as increased energy and overall fitness as a result of the FES system use. With further improvements in muscle response through innovative surgical techniques, the 16-channel implanted FES system can be a viable addition to exercise and mobility function in persons with paraplegia.

Walking with a hybrid orthosis system.

OBJECTIVE: The purpose of this case study was to determine the functional effectiveness of the hybrid orthosis system (HOS) for sit-to-stand and walking compared with the reciprocal gait orthosis (RGO) alone in a subject with significant orthopedic abnormalities. DESIGN: A subject with complete T7 paraplegia and a 13 cm leg length discrepancy was implanted with 14 intramuscular electrodes and fitted with a custom isocentric RGO. The subject was instructed in the use of the HOS and a two wheeled walker in the home and community settings. MAIN OUTCOME MEASURES: Using the Functional Independence Measure (FIM), and the Borg exertion scale the subject's level of independence and his perceived exertion was determined as well as the safety and efficacy of system use in the community. RESULTS: Results show that the HOS provided safe, independent ambulation with a two wheeled walker and met established criteria for limited community use. Walking in the RGO alone was feasible, however, the addition of functional electrical stimulation (FES) allowed this subject to walk farther and with less perceived exertion. CONCLUSION: This case study suggests that a hybrid orthosis system can be an effective clinical option for individuals with significant orthopedic complications that might otherwise contra-indicate the prescription of either conventional braces or FES alone.

Reliability of closed double helix electrode for functional electrical stimulation.

The reliability of a closed double helix electrode in the lower limbs was studied. This electrode is an implanted intramuscular electrode and is used for a totally implantable functional electrical stimulation system. Eighty electrodes were evaluated retrospectively with a mean period of 15 months. The total implant time was 1222 electrode months. The cumulative proportion surviving was 0.934 at 6 months, 0.855 at 1 year, 0.765 at 2 years, and 0.730 after 30 months. Fifteen of 80 electrodes failed, seven showed increasing electrode impedance, and eight had undesirable changes in recruitment. Of the failed electrodes, 2/3 failed during the first 10 months. The reliability was 0.91 at 6 months and 0.80 at 1 year after implantation in all muscle groups. The closed double helix electrode displayed an increased reliability when compared with the open double helix electrode at 6 months, and an equivalent reliability as compared with the electrodes developed by Handa and colleagues at 6 months and 1 year, using the chi squared test for independence. This study suggests that the closed double helix electrode has an acceptable reliability and can be used as a part of a totally implantable functional electrical stimulation system.

Implantation of a 16-channel functional electrical stimulation walking system.

A 16-channel electrical stimulation system was implanted in a 39-year-old patient with T10 paraplegia to restore sit to stand, walking, and exercise functions. System implantation required two surgical sessions. In the first session, the posterior muscle set consisting of bilateral semimembranosus, adductor magnus, and gluteus maximus muscles were exposed and epimysial electrodes sutured at the point of greatest muscle contraction. Closed double helix intramuscular electrodes were implanted in the erector spinae. Two weeks later, epimysial electrodes were attached to the eight anterior muscles consisting of the tibialis anterior, sartorius, tensor fasciae latae, and vastus lateralis with all 16 electrode leads passed to the anterior abdominal wall. The electrodes were connected to two eight-channel stimulators placed in the iliac fossae, and the system was checked by activating the individual muscles. The implanted stimulators received stimulation instructions and power via a radio frequency link to an external control. Stimulation patterns for standing, walking, sitting, and exercise functions were chosen from a preprogrammed menu via a finger key pad. After 3 weeks of restricted patient activity, all electrodes stimulated either the target muscle or had an acceptable spillover pattern. The patient is undergoing a 16-week rehabilitation course of stimulated exercises gradually increasing in intensity. At the conclusion, the goal is to discharge the patient with the system for spontaneous use. Although long term followup is required to determine system reliability, preliminary clinical results indicate that targeted, repeatable, functional muscle contractions in the lower extremity can be achieved with a system consisting of epimysial electrodes.

Endoscopic electrode implantation. A new technique in an animal model.

The purpose of this study was 2-fold: (1) to describe a technique of creating an endoscopic interstitial working space; and (2) to describe the technique of implanting the modified double helix and the Huntington cuff electrode in the space created. Two cannulated balloons were inserted on either side of a standard arthroscope, which had been inserted to identify the target branch of the sciatic nerve. Traction was applied on each cannula after inflating the balloons with 3 to 5 cc of saline, to create a cylindrical operating space between them. After mobilizing a segment of the nerve, either of the 2 electrodes was implanted with the aid of special instruments. The results indicate that (a) it is possible to create interstitial operating spaces reliably and consistently; (b) satisfactory hemostasis can be achieved through the tamponade effect of the balloons and endoscopic cautery units; (c) excellent visualization is achievable; and (d) it is possible to implant electrodes in a reproducible manner. The interstitial spaces are portable and can be used for various procedures in most anatomic locations. Modification of the cuff electrode will be necessary to make it easier for endoscopic implantation.

Design and clinical application of a double helix electrode for functional electrical stimulation.

An electrode, designed to be implanted without a surgical incision, was developed for skeletal muscle stimulation. Stainless steel, Teflon-insulated wire was wound into a helical lead around a polypropylene core and then rewound into a double helix configuration for stress relief during muscle contractions. The electrode tip was augmented with stainless steel barbs to increase anchoring strength. Electrodes were implanted with the help of specially modified hypodermic needles, sheaths, and passing tubes. 775 electrodes were implanted in a five year period in 22 subjects; accumulated implant time was 1,080 electrode years. 453 electrodes (65%) continue to produce strong, stable, muscle contractions. Electrode longevity varied with the location of implant. Electrodes were removed because of (1) inability to locate and properly place the electrode in a suitable site for stimulation during surgery (28.4%), (2) unwanted changes in muscle response to stimulation (91, 12%; one-third occurring during the first six weeks post implant), (3) increase in electrode impedance (74, 10%; assumed breakage, mostly occurring during the first year after implant), (4) intolerable pain during stimulation (8, 1%), and (5) infection (4, 0.5%). 67 (8%) electrodes were removed by accident or when the subjects left the program. This double helix electrode design has proven practical for achieving chronic stimulation of selected muscles in hemiplegic, paraplegic, stroke and brain-injured subjects with minimally invasive surgery.

External fixator pin insertion techniques: biomechanical analysis and clinical relevance.

A series of identically matched pairs of fresh-frozen canine femora (approximating human radii in size and dimension) were used to mechanically compare pull-out strength between 4 mm predrilled, self-tapping, half-pins and 4 mm self-drilling, self-tapping half-pins with drill bit-like cutting flutes. A second biomechanical and videotape analysis was done comparing the differences of pin insertion by power versus hand drilling. Results indicated a mean 22% reduction in bone purchase of self-drilling, self-tapping pins compared with that of predrilled pins and a marked increase in depth of insertion required of the self-drilling pins for comparable pin purchase (10 mm). It was also observed that a visible "wobble factor" exists, which tends to weaken the pin-bone interface when hand drilling is performed.

Repair of the tibiofibular syndesmosis with a flexible implant.

Fractures of the adult ankle with disruption of the tibiofibular syndesmosis require adequate stabilization of the ankle mortise to ensure satisfactory healing of the syndesmotic ligaments. Numerous internal fixation techniques for stabilization of the syndesmosis have been used. However, most techniques require partial device removal before weight bearing can be initiated. The "flexible syndesmosis repair" uses simple, inexpensive, readily available synthetic materials to restore distal tibiofibular stability. Once early fracture healing has been obtained, weight bearing is begun (average 6 weeks). Biomechanical testing on paired cadaver ankles demonstrated a suture tensile strength of 60 lbs and consistent suture-button strength of 49 lbs, whereas tricortical screw fixation was found to have a higher 82 lbs average pull-out strength, but demonstrated a wide variability depending on bone quality. Twelve patients have been managed with flexible syndesmosis repair and followed for 2-4 years. All fractures have healed without deformity and there are no cases of mortise instability. Subsequent analysis of devices removed 8-12 months following implantation has shown that all have remained intact without failure. The flexible syndesmosis repair is a reliable, stable way to restore syndesmosis integrity, allowing early weight bearing without need for interim surgery.