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

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.

Study Overview

• Status: Completed
• Conditions: Foot Drop
• Intervention / Treatment: Device: Cionic Neural Sleeve

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94133
      • Cionic, Inc.
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Cleveland State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional electrical stimulation in individuals with foot drop; Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction	Device: Cionic Neural Sleeve; Adaptive, functional electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cionic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): February 25, 2022

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Peroneal Neuropathies
• Other Study ID Numbers: CIONIC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No