Clinical Trial Protocol for Analyzing the Effect of the Intensity of FES-Based Therapy on Post-stroke Foot Drop

Positive assistive and therapeutic effects of FES have been proved for post-stroke subjects suffering from foot drop. However, the published studies are very heterogeneous in terms of methodology, therapy duration, session duration and session frequency, where most studies rely on intensive FES-based therapy. In this document a clinical protocol is proposed for analyzing the effect of medium and low intensity of FES-based therapy. The protocol is designed to be used with a surface multi-field FES system and it is based on available studies on literature and preliminary results with chronic post-stroke subjects. The proposed clinical trials could help determining the minimum necessary FES-based therapy intensity for obtaining positive therapeutic results.