Cionic Feasibility Study Finds Neural Sleeve Provides Significant Improvement to Gait

AI-powered wearable is designed to help people with neurological disorders regain functional movement for everyday activities.

Cionic

The Neural Sleeve has been in development for about three years.

Cionic Inc. designs “bionic clothing” to help restore mobility and improve the gait of people with cerebral palsy, multiple sclerosis, stroke, and other neurological disorders.The San Francisco-based company yestersday said that trials of its Neural Sleeve have resulted in an average improvement of 143% in foot drop in participants.

The Mayo Clinic defines foot drop as “a general term for difficulty lifting the front part of the foot” and “a sign of an underlying neurological, muscular or anatomical problem.” Cionic’s wearable device is intended to help restore mobility and improve the manner of walking for people with neurological disorders.

“It’s been incredible to see participants not just walk more confidently, but also show quantitative improvements in their gait,” said Jeremiah Robison, founder and CEO of Cionic. “Our participants are seeing 1.5x gain in dorsiflexion at heel strike, which means they’re clearing their foot through swing better, have a better chance to avoid falls, and have a more natural gait cycle.”

“This is a tremendous step in building a scalable neuromodulation platform to help people with movement disorders leverage their own bodies and rebuild neural pathways for greater independence,” he said.  

Cionic addresses growing need

The number of people affected by mobility challenges and the associated healthcare costs continue to rise, noted Cionic. According to the Centers for Disease Control and Prevention (CDC), in 2015, “disability-associated healthcare expenditures accounted for 36% of all healthcare expenditures for adults residing in the U.S., totaling $868 billion.”

About 13.7% of American adults suffer from mobility issues because of functional disabilities, said the CDC. Nearly 7 million Americans use a walker or wheelchair. By 2050, 20% of the developed world’s population will suffer from a physical impairment, said Cionic.

Motivated by his daughter's journey with cerebral palsy, Robison founded Cionic in 2018. The company said it combines the diagnostic power of a gait lab with the therapeutic power of functional electrical stimulation (FES) into a lightweight, durable, and stylish garment that can be worn anywhere and work everywhere.

Neural Sleeve applies algorithms to augment motion

Cionic said its Neural Sleeve analyzes, predicts, and augments a person’s movement. Using advanced algorithms, the system reads the signal sent from the brain to the muscles and can predict a person’s movement 1/10th of a second before their foot lifts off the ground.

The lower-leg Neural Sleeve uses a dense array of sensors to measure how the body is positioned and how individual muscles fire during movement. It predicts intended movement by measuring the electrical signal from the brain. Algorithms then analyze this data in real time to determine optimal muscle-activation patterns.

Cionic delivers FES to sequence proper muscle firing for natural movement. The company said it is an adaptive system that provides real-time augmentation and adjustment of the participant’s movement. The system can provide necessary assistance based on what can be measured of the participant’s neurological feedback and adjusts stimulation based on measured gait kinematics to optimize performance, it added.

Cionic is working with academic partners around the world and is conducting trials with the goal of scaling its offering to help people move with greater confidence and independence than with conventional wheelchairs, walkers, canes, or crutches.

Testing toward FDA submission

“This month, we completed both our human factors and efficacy testing, and we are now ready to submit our Neural Sleeve to the FDA,” said Robison. “This is a huge milestone for the company. So much invention and hard work has gone into this first product, and we cannot wait to bring it to the many people living with a gait impairment.”

Trial participant Patricia Allen survived a stroke in 2019 that drastically affected her mobility, especially her ability to negotiate stairs. She said she has used a quad-cane and an ankle-foot orthotic with less-than-satisfactory results. During one of her trial sessions, Cionic recorded Allen’s data while she walked outside.

“What Cionic is doing is a garment-type design so it’s not so obtrusive when you’re wearing it,” said Allen. “My last visit, I actually went out on the streets in North Beach in San Francisco—heavy population, all the flavors of San Francisco—and it was a feeling of inspiration for me that I haven’t felt for two-and-a-half years. It was an impactful moment for me, and I am encouraged by what they’re doing, what the product is, and how it’s developing.”

Cionic said its bionic clothing is designed to be discreet and engineered to assist people with neurological impairments. The company claimed that it is the first to have developed wearable technology to enable anyone living with mobility challenges to move with more freedom and confidence.


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Cionic

The Neural Sleeve has been in development for about three years.


Robot Technologies