Status:
COMPLETED
Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
Lead Sponsor:
Cionic, Inc.
Conditions:
Foot Drop
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05346640
Start Date
June 8 2021
End Date
February 25 2022
Last Update
March 12 2024
Active Locations (2)
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1
Cionic, Inc.
San Francisco, California, United States, 94133
2
Cleveland State University
Cleveland, Ohio, United States, 44115