Title:
Automated setup of functional electrical stimulation for drop foot using a novel 64 channel prototype stimulator and electrode array: results from a gait-lab based study.

Abstract:
Functional electrical stimulation is commonly used to correct drop foot following stroke or multiple sclerosis. This technique is successful for many patients, but previous studies have shown that a significant minority have difficulty identifying correct sites to place the electrodes in order to produce acceptable foot movement. Recently there has been some interest in the use of 'virtual electrodes', the process of stimulating a subset of electrodes chosen from an array, thus allowing the site of stimulation to be moved electronically rather than physically. We have developed an algorithm for automatically determining the best site of stimulation and tested it on a computer linked to a small, battery-powered prototype stimulator with 64 individual output channels. Stimulation was delivered via an 8×8 array adhered to the leg by high-resistivity self-adhesive hydrogel. Ten participants with stroke (ages 53-71 years) and 11 with MS (ages 40-80 years) were recruited onto the study and performed two walks of 10 m for each of the following conditions: own setup (PS), clinician setup (CS), automated setup (AS) and no stimulation (NS). The PS and CS conditions used the participant's own stimulator with two conventional electrodes; the AS condition used the new stimulator and algorithm. Outcome measures were walking speed, foot angle at initial contact and the Borg Rating of Perceived Exertion. Mean walking speed with no stimulation was 0.61 m/s; all FES setups significantly increased speed relative to this (AS p<0.05, PS p<0.01, CS p<0.01). Speed for PS (0.72 m/s) was faster than both AS (0.65 m/s, p<0.01) and CS (0.68 m/s, p<0.05). Frontal plane foot orientation at heel-strike was more neutral for AS (0.3° everted) than in the NS (11.2° inverted, p<0.01), PS (4.5° inverted, p<0.05) and CS (3.1° inverted, p<0.05) conditions. Dorsiflexion angles for AS (4.2°) were larger than NS (-3.0°, p<0.01), not different to PS (4.3°, p>0.05) and less dorsiflexed than CS (6.0°, p<0.05). This proof of principle study has demonstrated that automated setup of an array stimulator produces results broadly comparable to clinician setup. Slower walking speed for automated and clinician setups compared to the participants' own setup may be due to the participants' lack of familiarity with responses different to their usual setups. Automated setup using the method described here seems sufficiently reliable for future longer-term investigation outside the laboratory and may lead to FES becoming more viable for patients who, at present, have difficulty setting up conventional stimulators.