This study will compare the performance of a novel data-driven model-predictive controller (MPC) based functional electrical stimulation (FES) system versus a conventional FES system for footdrop correction during treadmill and overground walking tasks in people post-stroke.
>6 months since stroke
cortical or subcortical stroke
able to walk 10-meters with or without an assistive device
sufficient cardiovascular health and ankle stability to walk on treadmill without ankle orthosis
cerebellar signs
score >1 on question 1b (does not know the current month and age) and >0 on question 1c (can not blink eyes and squeeze hands) on NIH Stroke Scale
inability to communicate with investigators
neglect/hemianopia
Crossover
Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES)
DeviceThe model-predictive controller (MPC) determines the timing and intensity of electrical stimulation delivered for FES. MPC combined with real-time ultrasound-based feedback delivers optimal FES intensities and minimizes fatigue. FES is delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
Conventional Functional Electrical Stimulation (FES)
DeviceFor functional electrical stimulation, surface electrodes are placed on the paretic leg on skin overlying the tibialis anterior (TA) muscle, with intensity pre-set to elicit dorsiflexion to neutral against gravity. FES will be delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
Number of Adverse Events
Safety is assessed as the number of adverse events experienced by study participants.
Count of Risks
Safety is assessed as the count of risks, including falling, discomfort, pain, skin problems, fatigue, and soreness.
Participant Perception of Comfort
Participant perception of comfort is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most comfortable.
Participant Perception of Acceptability
Participant perception of acceptability is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most acceptable.
Peak Ankle Dorsiflexion Angle During Swing
Gait biomechanics performance is assessed as the peak ankle dorsiflexion angle during swing. The normal range for peak ankle dorsiflexion is 0 to 5 degrees.
Overground Walking Distance
Gait performance is assessed as overground walking distance traveled, in meters, during a 6-minute walk test.
FES Intensity
FES system performance is assessed as FES intensity. FES intensity is measured during a treadmill walking bout. Intensity is measured by milliamps (mA) or millivolts (mV).
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Emory University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
