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

Cionic

Status: Completed

Conditions: Foot Drop

Treatments: Device: Cionic Neural Sleeve

Study type: Interventional

Funder types: Industry

Identifiers

NCT05346640

CIONIC-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Functional electrical stimulation in individuals with foot drop

Experimental group

Description:

Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction

Treatment:

Device: Cionic Neural Sleeve