N/A
N=60
Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
Foot Drop
Bottom Line
View on ClinicalTrials.gov: NCT05346640 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Mean Dorsiflexion at Heel Strike — 5.2 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cionic Neural Sleeve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cionic, Inc.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Dorsiflexion at Heel Strike |
5.2 | — |
| PRIMARY Mean Ankle Inversion During Swing Phase |
-3.6 | — |
| SECONDARY Mean Foot Angle at Heel Strike |
5.5 | — |
| SECONDARY Mean Heel-Toe Time as a Percent of Gait Cycle |
3.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05346640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.