Cionic Neural Sleeve
DeviceAdaptive, functional electrical stimulation
NCT Number: NCT05346640
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Cionic, Inc., San Francisco, California, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adults aged 18-70
Exclusion criteria
Adaptive, functional electrical stimulation
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.
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
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.
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.
Cionic, Inc.
Industry
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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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