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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Foot Drop

Intervention / Treatment
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* Device: Cionic Neural Sleeve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A one-group, pre-test post-test study.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cionic Neural Sleeve|Adaptive, functional electrical stimulation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dorsiflexion at heel strike measured in degrees | Measured by IMU sensors placed on the foot and lower leg, and heel strike is determined from pressure sensors in the shoe | 60 minutes | 
| Mean ankle inversion during swing phase measured in degrees | Measured by IMU sensors placed on the foot and lower leg, and swing is determined from pressure sensors in the shoe | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot angle at heel strike measured in degrees | Measured by IMU sensors placed on the foot and lower leg, and heel strike is determined from pressure sensors in the shoe | 60 minutes | 
| Heel-toe Time measured in seconds | The duration between heel strike and toe strike measured by pressure sensors placed in the shoe | 60 minutes |