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

NCT ID: NCT05346640

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2022-02-25

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 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).

Conditions

Foot Drop

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Cionic Neural Sleeve

Intervention Type: DEVICE

Adaptive, functional electrical stimulation

Interventions

Cionic Neural Sleeve

Adaptive, functional electrical stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cionic, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Rebecca Webster

Clinical Operations

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cionic, Inc.

San Francisco, California, United States

Cleveland State University

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIONIC-001

Identifier Type: -

Identifier Source: org_study_id