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OpenTrials
Completed

NCT Number: NCT05346640

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cionic, Inc., San Francisco, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cionic Neural Sleeve

Device

Adaptive, functional electrical stimulation

Primary outcomes

  1. Mean Dorsiflexion at Heel Strike

    Time frame: 60 minutes

    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.

  2. Mean Ankle Inversion During Swing Phase

    Time frame: 60 minutes

    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

Secondary outcomes

  1. Mean Foot Angle at Heel Strike

    Time frame: 60 minutes

    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.

  2. Mean Heel-Toe Time as a Percent of Gait Cycle

    Time frame: 60 minutes

    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.

Sponsors and collaborators

Lead sponsor

Cionic, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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