Synergy-based Functional Electrical Stimulation for gait rehabilitation in chronic stroke: a pilot study.

This was a pilot study with seven participants in each group, and the authors state it was not powered to identify between-group differences. One HIGT participant dropped out before midpoint because of a pre-existing medical issue and was not included in the analysis. Assessors were not blinded, and only the MFES + HIGT group wore the sleeve during training, so compression or attention could have influenced results. The groups were variable in age, time since stroke, and baseline function, and the HIGT group had slightly greater baseline function although the difference was not significant. The three household ambulators did not reach the target heart-rate zone, so the full high-intensity training dose was not delivered to these participants. The analysis excluding household ambulators was exploratory, so subgroup improvements cannot be treated as definitive. The MFES + HIGT intervention combined stimulation with high-intensity gait training, so improvement in that group cannot be separated from the training component. Setup time was recorded for only one participant per therapist, so the plateau may reflect learning with that person as well as general therapist proficiency. The custom hip unit required manual placement and occasionally disconnected from the system, which affected setup time and confidence.

Funding came from Northwestern University and Shirley Ryan AbilityLab, and the authors declared financial support for the work or publication. The study used a modified Cionic Neural Sleeve, and Cionic developed the custom hip unit.

Do not conclude that synergy-based MFES is proven better than high-intensity gait training alone. The study found no significant group difference on the main walking outcomes, and it was a small pilot not powered to compare groups. Improvements in the stimulation group also cannot be separated from the high-intensity gait training it was given with.