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

Cionic, Inc.60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Foot Drop

Interventions

Cionic Neural SleeveDEVICE

Adaptive, functional electrical stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: Adults aged 18-70 * Lower extremity impairment that makes walking difficult or uncomfortable * Capable of sitting, standing, and walking independently or with assistance * Able to walk at least 50 feet independently or with assistance * Able to understand and follow basic instructions in English 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

Locations (2)

Cionic, Inc.

San Francisco, California, United States

Cleveland State University

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Mean Dorsiflexion at Heel Strike

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.

Time frame: 60 minutes

Mean Ankle Inversion During Swing Phase

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

Time frame: 60 minutes

Secondary Outcomes

Mean Foot Angle at Heel Strike

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.

Time frame: 60 minutes

Mean Heel-Toe Time as a Percent of Gait Cycle

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.

Time frame: 60 minutes

Data from ClinicalTrials.gov

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