Bioness Inc has announced the results of a recent study that shows significant improvement in gait speed when stroke patients utilized the Bioness L300 Foot Drop System. The study, titled “Response and Prediction of Improvement in Gait Speed from Functional Electrical Stimulation in Post-Stroke Drop Foot,” demonstrated that subjects with chronic stroke can achieve a meaningful improvement in the speed of their ambulation with functional electrical stimulation (FES) therapy, according to a Bioness news release.
The Bioness news release notes that subjects using the L300 had their gait speed progressively improve over 42 weeks, with ≥50% of subjects achieving a clinically meaningful 42-week total effect and 50% achieving their maximum gait speed by 12 weeks. Overall, the group experienced an immediate increase of walking speed of 19%, which continued to improve to 33.3% and 45.2% at 30 and 42 weeks, respectively.
Michael W. O’Dell, MD, lead author of the paper, says, “In addition to statistically important changes, we documented practical, clinically important changes in gait speed as a result of the treatment.”
The L300 system provides FES to the muscles of the lower leg to help lift the foot up through wireless synchronization while walking. The system is used as a primary medical device to address drop foot and has been cleared by the Food and Drug Administration (FDA) to improve gait in persons with neurological impairments, such as stroke or spinal cord injury, according to Bioness.
Keith McBride, DPT, vice president of marketing and development, states, “The long-term results of the FASTEST trial reveal that the Bioness L300 provides clinically significant and sustaining benefit in this underserved cohort of persons with foot drop.”
McBride adds, “The magnitude of the outcomes under the rigorous controls and methods of the trial will provide additional essential data to third-party payors to consider for coverage of the functional electrical stimulation systems like the L300 to include persons with foot drop following stroke.”