Long-term performance and user satisfaction with implanted neuroprostheses for upright mobility after paraplegia: Two to 14-year follow-up

Publication date: Available online 9 September 2017
Source:Archives of Physical Medicine and Rehabilitation
Author(s): Ronald J. Triolo, Stephanie Nogan Bailey, Kevin M. Foglyano, Rudi Kobetic, Lisa M. Lombardo, Michael E. Miller, Gilles Pinault
ObjectiveTo quantify the long-term (LT) (>2 years) effects of lower extremity (LE) neuroprostheses (NPs) for standing, transfers, stepping and seated stability after spinal cord injury.DesignSingle-subject design case series with participants acting as their own concurrent controls, including retrospective data review.SettingHospital-based clinical biomechanics laboratory with experienced (>20 years in the field) research biomedical engineers, physical therapist and medical monitoring review.ParticipantsTwenty-two (19 male, 3 female) LT (6.2 ± 2.7 years) at-home users of implanted NPs for trunk and LE function with chronic (14.4 ± 7.1 years) spinal cord injury resulting in full or partial paralysis.InterventionsTechnical and clinical performance measurements, along with user satisfaction surveys.Main Outcome MeasuresKnee extension moment, maximum standing time, body weight supported by lower extremities, three functional standing tasks, two satisfaction surveys, NP usage, and stability of implanted components.ResultsStimulated knee extension strength and functional capabilities were maintained with 94% of implant recipients reporting being "very" or "moderately" satisfied with their system. Greater than half (60%) of the participants were still using their implanted NPs for exercise and function for more than 10 minutes per day on nearly half or more of the days monitored, although maximum standing times and percentage body weight through LEs decreased slightly over the follow-up interval. Stimulus thresholds were uniformly stable. Six-year survival rates for the first-generation implanted pulse generator (IPG) and epimysial electrodes were close to 90%, while those for the second-generation IPG along with the intramuscular and nerve cuff electrodes were greater than 98%.ConclusionsObjective and subjective measures of the technical and clinical performances of implanted LE NPs generally remained consistent for 22 participants after an average of 6 years of unsupervised use at home. These findings suggest that implanted LE NPs can provide lasting benefits that recipients value.



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