For those with walking difficulties arising from neurological conditions such as multiple sclerosis, Parkinson’s and cerebral palsy — augmenting mobility in a manner that seamlessly blends with the human body has always been something of a holy grail for medical researchers.
Of course, canes, walkers, wheelchairs and even ankle splints have contributed much over the years to help patients maintain independence but all of these either provide passive assistance or an entirely different way of mobilizing from point to point.
One medical technology that aligns more closely to this ideal of more complete integration with the musculoskeletal system is functional electrical stimulation or FES.
FES, which was first developed in the 1960s, involves the placement of external wired electrodes on the lower limbs to activate muscles for which the nerve pathway from the brain has been damaged through neurological disease or injury.
Now, San Francisco-based medical engineering firm Cionic is fixing its gaze on powering up FES by several orders of magnitude by marrying it with smart technology and cutting-edge movement sensors all housed within a regular piece of apparel resembling a legging.
The Cionic Neural Sleeve, as it is known, is a first-of-its-kind attempt at creating clothing that is truly bionic — endowing its wearers with the potential of making gains in the areas of walking speed, balance, gait efficiency and overall safety.
|Form and functionality|
The Neural Sleeve is the brainchild of Cionic founder and CEO Jeremiah Robison.
Robison was able to apply his decades of experience working in the areas of embedded systems and machine learning for the likes of Apple, Openwave, Slide and Jawbone to assess how simple FES systems were being used in clinical practices by visiting gait laboratories with his daughter.
Robison’s daughter, who is now 13 years old, was born with cerebral palsy and was inducted with a FES system when she was nine.
Given the necessity to accommodate both gait sensors and twenty-four separate electrodes within the garment to conjure up a unique recipe of electrical stimulation for every patient – achieving the most appropriate form factor was always going to be a make-or-break endeavor.
This was particularly so — as some of the major drawbacks of traditional FES systems is that they can be taxing to apply — usually involving a mess of wires, whilst efficacy can be hit and miss due to the patient needing to precisely place the electrodes themselves.
To attend to this fundamental element of functionality and wearability, Cionic teamed up with world-renowned Swiss industrial designer Yves Behar and his studio fuseproject.
Specializing in the marriage of technology with the human body, California-based fuseproject works across diverse sectors including robotics, technology, furniture and consumer goods and boasts the likes of Samsung, Prada, SodaStream and Nivea amongst its client list.
“Through our design process, which involved the development of over 50 prototypes, we learned just how critical — and nuanced — ease of use is for people with limited mobility,” explains Behar.
He continues, “The crux of the design centers on a donning and doffing sequence that prioritizes the positioning and placement of the electrodes responsible for delivering the electric pulse stimulation.
“With more than 200 million individuals worldwide with mobility impairment, we understand the challenge as a global one: technology that can analyze and augment movement coupled with an elegant form factor. The idea is that design can deliver freedom of mind, more control of the body, and faster rehabilitation,” Behar says.
|A sequenced symphony of stimulation|
The final result, which was announced this week, is an FDA-approved medical garment with the potential to transform the lives of millions of patients around the world.
In addition to ease of use, what the Neural Sleeve can offer patients over and above traditional FES systems, is a focus on multiple muscle groups at the same time – namely the hamstring, quadriceps, calf and shin.
Traditional FES is usually limited to stimulating just the ankle dorsiflexors, the muscles around the foot responsible for lifting the toes off the ground during the gait cycle.
By activating multiple muscle groups, the sleeve can orchestrate and sequence a series of smaller movements, that, when added together, help create a healthier, more purposeful stride.
“The innovation we are bringing to patients with the Neural Sleeve is the ability to algorithmically sequence all four major muscle groups, and steer this through software,” explains Robison.
Addressing this orchestrated neurological symphony for naturally enhancing movement, Dr. Jacqueline Nicholas, System Chief Neuroimmunology and Multiple Sclerosis at the OhioHealth MS Center affirmed, “This is the first comprehensive system that addresses key muscle groups of the leg, which means it has the potential to improve mobility and function with continued use.”
Beverly Chaidez, who lives with multiple sclerosis and participated in Cionic’s home usability trials said, “When I started the home usability trial, I was only able to walk for about five to 10 minutes at a time, and I used a wheelchair for mobility outside of the home.
“Today, I can walk for 40 to 50 minutes at a time and I haven’t used my wheelchair in over a month. I feel hopeful and optimistic that I can regain a lot of things that I lost.”
Aside from the quality-of-life improvements for patients, additional therapeutic value comes from the sleeve being a Read + Write Neural Interface which means it is collecting highly granular data related to movement, as well as proving tailored stimulation to enhance the movement itself.
This data can then be used by physical therapists as well as other health professionals to better understand how the device is working and the ways in which the patient’s condition might be changing.
Out of the box, the Neural Sleeve can be configured remotely in less than an hour using the dedicated app via a telehealth appointment with a Cionic technician with fortnightly, and later, monthly, follow-ups to complete the onboarding process.
The company is currently opening up what it refers to as its Founders Program which will involve monitoring a small cohort of early adopters over a lengthier period in the hope of augmenting some already promising clinical trial data with further insights on potential economic outcomes that can help inform health insurance reimbursement decisions further down the line.
|Feeling the future|
Speaking of the future, Robison firmly believes that bionic clothing worn for all kinds of purposes will come to the fore in the years ahead — fueled by consumer-grade fitness tracking technology such as Apple Watch, as well as higher-end devices used in elite sport.
“When analyzing human physical performance – it’s all part of the same continuum from people with disabilities right through to Usain Bolt,” says Robison.
In shaping a future where perhaps one day all human beings will be bionically augmented through the garments they wear, Robison views helping people with disabilities as the most logical and worthwhile starting point:
“One day all clothing will have the ability to analyze and assist the body and our wearing habits will eventually adapt to the technology,” claims Robison.
“It’s important to start out with something where there’s a real need — so as to avoid that Google Glass effect, where, in the beginning, nobody understands why anybody would ever need it,” he explains.
“Now, we have something where there’s a real tangible benefit that justifies this first garment and that should allow us to further build our knowledge and continue to iterate.”
Whether it’s pushing the boundaries of human potential, or attempting to restore lost function – achieving this through something everybody uses all day, every day without even thinking about it, is surely likely to yield the highest chance of success.
|I am a journalist specializing in issues affecting people living with physical disabilities. My interest in the subject stems from being diagnosed with multiple sclerosis at the age of 26. Since this time, I have written on the topics of health, social justice and accessibility for a number of newspaper titles including The Times, Daily Mail, The Guardian, The Independent and The Telegraph. I have a keen interest in sight enhancement technology and supporting those living with low vision through voice recognition, speech output and AI. I have also served as a director and trustee of Shift.ms, a social network and global forum for people with multiple sclerosis. Additional journalistic ventures have included biography writing for Asian Media Group, as well as SEO and content marketing for Croud. I studied Modern History at the University of Warwick and have also worked at Experian and Google U.K. Follow me on LinkedIn.|
Augmenting gait in a population exhibiting foot drop with adaptive functional electrical stimulation, Jeremiah Robison, Ren Gibbons, Dean Achelis, Brinnae Bent, Doug Wajda, Rebecca Webster. medRxiv 2022.04.27.22273623; doi: https://doi.org/10.1101/2022.04.27.22273623. Full text, PDF
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