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

Foot Drop Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346640
• Other study ID #: CIONIC-001
• Status: Completed
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: August 2023
• Source: Cionic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Foot Drop
• Peroneal Neuropathies

Intervention

Device:
• Cionic Neural Sleeve
Adaptive, functional electrical stimulation

Locations

Country	Name	City	State
United States	Cleveland State University	Cleveland	Ohio
United States	Cionic, Inc.	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Cionic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 minutes
Primary	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	60 minutes
Secondary	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.	60 minutes
Secondary	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.	60 minutes