Clinical Evidence

CIONIC is continually conducting research trials to demonstrate the efficacy of the Neural Sleeve for the treatment of mobility impairment. Our first multi-site study examined the benefits of the Cionic Neural Sleeve to assist individuals with foot drop.

Interested in participating in our research trials? Start here.

Foot Drop

Nearly 14% of adults in the US have mobility impairments [cit]. Walking difficulties compromise both physical safety and emotional well-being and can lead to a number of other health complications [cit]. One of the most common mobility impairments is foot drop, which is difficulty in flexing the ankle to lift the foot, due to disruptions to the peroneal nerve [cit]. This causes the front of the foot to drag on the ground during walking [cit], resulting in instability and increasing fall risk [cit].

In our multi site research trial we examined the efficacy of the Cionic Neural Sleeve to assist individuals with foot drop. Participants were outfitted with the Neural Sleeve on their most impacted leg. Stimulation parameters of frequency, pulse width, and amplitude were tuned to elicit activation of the dorsiflexors, and then the user performed back-to-back collections, with and without gait assist stimulation.

Figure 1. Top left: Cionic Neural Sleeve showing FES and EMG electrodes. Top right: CIONIC application interface for setting FES parameters (frequency, pulse width, intensity) and current field steering. Bottom: Participant with sleeve on affected limb on marked walkway.

Like many studies on foot drop, our primary endpoint was increasing ankle dorsiflexion at heel strike for improved foot clearance.

In back-to-back paired tests,
94% of participants showed positive increase to dorsiflexion at heel strike.

But ankle dorsiflexion is only part of the story. Many individuals with foot drop also exhibit excessive ankle inversion, which can cause the foot to land on the outside, risking ankle injury and falls.

Our first-of-its-kind software steerable stimulation array enables the Cionic Neural Sleeve to balance increases in dorsiflexion with reduction to inversion.

88% of participants showed a positive improvement to ankle inversion during swing.

Every individual is unique: some require greater assistance in increasing dorsiflexion, while others need more help reducing inversion. Stacking together the improvements to both these metrics for each participant, we see a more comprehensive picture of the impact of the Cionic Neural Sleeve for individuals with foot drop.

Our gait assist trial demonstrated an average combined improvement of 9° across all participants.

Link to the full pre-print is here.

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