NeuroVoices: Joe Kardine, MS, OTR, CBIS, on the Functionality and Applicability of the NuroSleeve Powered Arm Brace

Joe Kardine, MS, OTR, CBIS

As technology continues to advance, so do the capabilities of those working in rehabilitative settings. Over the past decade, there has been an influx of soft robotics or functional electrical stimulation devices being incorporated into the healthcare field, some of which are designed specifically to restore hand and arm function. Although arm weakness is traditionally utilized for patients post stroke, there are several other neurological conditions, including spinal muscular atrophy, cerebral palsy, and amyotrophic lateral sclerosis (ALS), that experience this type of functional loss.

The Jefferson Center for Neurorestoration at Thomas Jefferson University has been on a mission to help develop, refine, and make available wearable and implantable neurotechnologies to improve mobility of those living with chronic conditions. The most recent project headed by the center involves the use of the NuroSleeve, which is combined powered arm brace and muscle stimulation system designed to help restore arm function. The trial will assess the NuroSleeve in a range of neurological conditions, with changes on Canadian Occupational Performance Measure at 8 weeks as the primary outcome measure.

As part of a new iteration of NeuroVoices, Joe Kardine, MS, OTR, CBIS, clinical program manager, Jefferson Center for Neurorestoration, sat down to discuss this new study, as well as the clinical application of the NuroSleeve. He provided commentary on the objectives of the trial, the reasons why the device can be applied across several different conditions, and whether there were limitations with who could use it.

NeurologyLive^®: How does the NuroSleeve function?

Joe Kardine, MS, OTR, CBIS: The NuroSleeve device is a 3D printed device that is powered by what they call a linear actuator. The patient has full control over it, and there is a little joystick on the device that helps the patient open and close their hand, as well as a sensor or what they call it an inertial measurement unit to open and close the hand based on the touch of the sensor or the movement of how the sensor moves. It gives the ability to a patient who can put the sensor anywhere on their body, and however they move their body. It opens and closes the device, or they can use a little joystick just to open and close themselves.

How is this device applicable to so many neurological disorders?

Talking about the design of the trial, our thought process was not to have such specific usage of the device. The design of the trial is to help anyone with upper extremity impairment or paralysis or weakness or dysfunction. You can use that term to cover a lot of different areas of difficulty, and having said that, that also covers many patient populations and not just one specifically. The device is lightweight and It's customized. We scan the person's arm to kind of see the anatomy, where the bony prominences may be, to fit appropriately, as that is an often-difficult thing for any over the shelf device splint. Being able to customize something allows you to open the window to anybody who could be appropriate for it.

So far, our trial has been heavy in the stroke population, if we’re being honest. Those are the folks so far that have wanted to participate. Also, we've been working with other specialty physicians within other patient populations, which seem to be in line to participate. We're excited to see the mix of the outcomes. Additionally, the trial is also designed as a partnership with Nemours Children's Hospital in Wilmington, Delaware. We are working on the pediatric cohort of the trial and recruiting patients with cerebral palsy, arthrogryposis, traumatic brain injury, and keeping it very general, because the goal is that this is a need as an assistive device, but also could provide some restorative function based on just increased usage of the affected extremity.

When you don't use something, the anatomy will tend to change. Sure, it will become weak, but also what people may not realize that certain muscles shorten, and your anatomy changes. Just by using the affected extremity, even passively, is helpful in function, but also, it kind of reiterates on the back end what therapy may have reiterated throughout the recovery. It's a different way of doing it and also more engaging, because you're starting to involve both extremities and somewhat of what normal function used to be like.

Are there any limitations on who can use this intervention?

Some of the exclusions are people with very, very severe impairments. That will be someone with many contractures on their extremities. If their wrist is in a contracture, flexion, or deviation that wearing this device would essentially cause harm. Obviously, we're not going to want someone to use that. That's a standard in any clinical research trial. But we have had some participants with what you would call more of a higher, moderate injury, where they have a lot of spasticity, where they may not be able to bend their elbow all the way, or their fingers are really tight, and they can’t open.

In the research trial, we provide the electrical stimulation with the device, so they're working in tandem, which that also sort of treats the spasticity. It helps engage function, but any thing where this would cause harm, we would obviously screen that upfront, as we evaluate the patient. Also, for someone who has skin breakdown or at risk of having a cut from vascular conditions, we're not going to harm anyone with that. There are ways around that though. We've made some modifications to the device to prevent skin breakdown, even if it wasn't necessary, we just do it anyway. In therapy, we’ve added moleskin and padding. But really, you could put a thin layer of moleskin within the device, because the material used for the 3D printing is totally safe to do so, it's functional, and it doesn't break down. We can curve the edges appropriately. We've gotten around a lot of things where maybe they wouldn't have been appropriate for certain devices. There are not many contraindications and that's great. That's the point. The goal in the design of this trial was about function and not about necessarily specific clinical aims, as well as a therapeutic game. Occupational or physical therapists can deploy this trial with a patient. The goal is always function, and it's about what the patient wants to gain from it. We've been able to achieve most of those goals.

Transcript edited for clarity. Click here for more NeuroVoices.