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

NCT05346640 | Completed Results

• 1 other identifier: CIONIC-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Foot Drop

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mean Foot Angle at Heel Strike

  60 minutes

• Mean Heel-Toe Time as a Percent of Gait Cycle

  60 minutes

Study Arms (1)

Functional electrical stimulation in individuals with foot drop

EXPERIMENTAL

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

Interventions

Cionic Neural Sleeve DEVICE

Adaptive, functional electrical stimulation

Functional electrical stimulation in individuals with foot drop

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cionic, Inc.: lead

Study Sites (2)

Cionic, Inc.

San Francisco, California, 94133, United States

Location

Cleveland State University

Cleveland, Ohio, 44115, United States

Location

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

This study did not include the collection of certain traditional gait analysis metrics including spatial measures like gait speed and stride length as we relied solely on the on-body device for all data collection and metric extraction. Additionally, we were not able to compare functional electrical stimulation treatment impacts relative to standard of care, i.e. ankle-foot orthosis, in a randomized control trial (RCT). An RCT remains a future research study.

Results Point of Contact

• Title: Rebecca Webster, Clinical Operations Manager
• Organization: Cionic

rebecca@cionic.com

9257886649

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Operations

Model Details: A one-group, pre-test post-test study.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 26, 2022
• Study Start: June 8, 2021
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)