Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation

Not Applicable

Completed

Brief Summary: The objective of this study is to investigate the effects of personalized, adaptive, current-steering functional electrical stimulation (FES) of the lower leg to improve gait in people with foot drop.

Detailed Description: Adaptive, current-steering FES enables precise control over dorsiflexor and evertor muscles, allowing for personalized treatment to correct key foot drop characteristics including dorsiflexion at heel strike and ankle inversion during swing phase. All participants will receive adaptive FES of the dorsiflexors and evertors during back-to-back walking sets. Participants completed up to three walking sets of unstimulated walking (pre-test) followed by lower-leg stimulated walking (post-test). The primary outcome measures include ankle dorsiflexion at heel strike and mean ankle inversion during swing phase. Secondary outcome measures include foot angle at heel strike and single-side heel strike to toe strike time (heel-toe time).

Recruitment & Eligibility

Inclusion Criteria

Adults aged 18-70

Exclusion Criteria

Have non-reversible damage to the peripheral nervous system
Have underlying pre-existing conditions like thrombosis/hemorrhage, severe epilepsy or other seizure disorder, severe atrophy or history of implanted electrical devices
Have cognitive impairment that would prevent you from fully understanding the study and ability to provide informed consent
Have lower motor neuron disease or injury that may impair response to stimulation
Are pregnant
Are under the age of 18 years old
Have skin conditions of the affected lower limb, including cuts, burns or lesions

Arm && Interventions

Group	Intervention	Description
Functional electrical stimulation in individuals with foot drop	Cionic Neural Sleeve	Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction

Primary Outcome Measures

Name	Time	Method
Mean Dorsiflexion at Heel Strike	60 minutes	Dorsiflexion measured via inertial measurement unit (IMU) sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe.
Mean Ankle Inversion During Swing Phase	60 minutes	Ankle inversion measured via IMU sensors placed on the foot and lower leg, measured in degrees. Swing phase is determined from pressure sensors in the shoe

Secondary Outcome Measures

Name	Time	Method
Mean Heel-Toe Time as a Percent of Gait Cycle	60 minutes	Time of heel-toe, or single-side heel strike to toe strike measured by percent of gait, where 0% represents heel strike and 100% is the next heel strike. Heel strike assessed by pressure sensors placed in the shoe.
Mean Foot Angle at Heel Strike	60 minutes	Foot angle measured via IMU sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe.