NCT05346640

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cionic, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Foot Drop

Interventions

Type	Name	Description
DEVICE	Cionic Neural Sleeve	Adaptive, functional electrical stimulation

Timeline

• Start date: 2021-06-08
• Primary completion: 2022-02-25
• Completion: 2022-02-25
• First posted: 2022-04-26
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

2 sites across 1 country: United States