Impact of the Cionic Neural Sleeve on Ankle Kinematics During Gait in Individuals Who Sustained a Cerebrovascular Accident

Research Objectives: To investigate the effects on foot kinematics of a novel functional electrical stimulation (FES) device (Cionic Neural Sleeve, CIONIC Inc., San Francisco, CA) in individuals who sustained a cerebrovascular accident (CVA).

Design: Interventional, pre-post study.

Setting: Academic and private sector laboratory settings.

Participants: Twenty individuals from a volunteer sample who have had a CVA (age 58.75 ± 12.90, n = 13 female).

Interventions: During a single visit to the lab, participants completed walking trials at a “normal comfortable pace” while wearing the Cionic Neural Sleeve on the hemiparetic leg. Walking was completed in two conditions: with stimulation and without stimulation.

Main Outcome Measures: Dorsiflexion (DF) at heel strike and inversion/eversion during swing for both walking conditions.

Results: In the unstimulated walking condition, participants exhibited -3.98° ± 7.22° of DF at heel strike and 7.94° ± 9.58° of inversion during swing. During the stimulated walking condition, DF values significantly increased (p = 0.001) by an average of 4.14° ± 4.46° and inversion was significantly reduced (p = 0.029) by 3.20° ± 5.12°. Overall improvements to DF at heel strike and reductions to inversion during swing were observed in all twenty participants with FES delivered by the Cionic Neural Sleeve.

Conclusions: These initial findings suggest that the Cionic Neural Sleeve has a significant impact on ankle kinematics in individuals who have had a CVA. The Cionic Neural Sleeve's customizable, array based programming offers an active solution to the immediate management of foot drop, though future work is needed to investigate long-term use of the device and its impact on gait stability and sustained improvement.

Author(s) Disclosures: This research was carried out under a Sponsored Research Agreement between Cleveland State University and Cionic Inc.