Introduction Chronic stroke gait disorders are characterized by impaired motor coordination (i.e., muscle synergies), which are related to functional impairment. While high-intensity gait training (HIGT) is the standard of care, and functional electrical stimulation (FES) to the tibialis anterior can address foot drop, evidence has shown that extending FES to multiple muscles improves functional and biomechanical outcomes. The Cionic Neural Sleeve provides a wearable platform that allows customizable stimulation to muscles of the leg with clinically feasible time to prepare the device and a user-friendly interface. We investigated the efficacy and clinical implementation of a personalized intervention based on the individual’s specific motor coordination impairment–muscle synergy-based multichannel FES (MFES)–paired with HIGT to improve gait speed, endurance, biomechanics, and similarity of synergies to normative data.

Methods Fourteen individuals (six females) with chronic stroke gait impairments were recruited and randomly divided into two groups, both receiving six weeks of either HIGT or MFES+HIGT. Assessments of gait speed, endurance, balance, gait biomechanics, and muscle synergies were conducted at baseline, midpoint, post, and one month following completion of training. Feasibility was assessed with time to prepare the system and participant and therapist questionnaires.

Results Despite a small sample size, only the MFES+HIGT group had sustained improvements in fast walking speed and endurance. Additionally, only MFES+HIGT led to reduced double support percent improved hip extension during stance while HIGT led to improved step length but reduced ankle dorsiflexion during swing and a greater degree of hip external rotation. Finally, average similarity of muscle synergy activation profiles to normative data, measured through cross correlation, improved only for MFES+HIGT. Time to prepare the device plateaued at nine sessions at 4.53 minutes, and both participants and therapists rated the intervention highly feasible, acceptable, and usable.

Discussion Muscle synergy-based MFES+HIGT demonstrated improved outcomes in gait speed, endurance, biomechanics, and motor coordination with positive feedback on a highly usable and feasible stimulation interface. This research supports further pursuit of this personalized intervention through a randomized controlled clinical trial with larger sample sizes that can better characterize how individuals with varying baseline function respond to this personalized intervention.

Robison J, Webster R, Smith T, and Sakai J are employed by CIONIC Inc. and may hold equity in the company. These individuals contributed to device design and provided technical support but were not involved in the study design, participant selection, therapist or participant training, outcome assessments or data analysis, in order to minimize potential bias.

NCT06099444

Shirley Ryan AbilityLab and Northwestern University.

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The study protocol was approved by the Northwestern University Institutional Review Board (STU00218244) and conducted in accordance with the Declaration of Helsinki.

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