Hard Bionics Medical Devices

Cyberdyne’s HAL Exoskeleton Helps Patients Walk Again in First Treatments at U.S. Facility

Patients at a Florida clinic are the only ones in the United States with access to Cyberdyne’s HAL exoskeleton, but that will change in 2019.

Photo: Amy Nordrum
Danny Bal completes a treatment session with Cyberdyne’s HAL exoskeleton at Brooks Rehabilitation in Jacksonville, Fla., as his granddaughter cheers him on.

Danny Bal was riding his brand new motorcycle to work from his home in Ocala, Fla., two years ago when the driver of an oncoming car fell asleep and plowed into Bal’s electric-blue bike.

After the accident, which crushed three of Bal’s thoracic vertebrae and shredded a spinal nerve, Bal adjusted to life in a wheelchair. He added a motorized lift to his beloved F-250 truck, explored local trails with a hand-powered bike, and joined a therapeutic horseback riding program.

Now, one of Bal’s daughters is about to get married, and 57-year-old Bal wants to walk in her ceremony. So on a recent Friday morning in December at Brooks Rehabilitation in Jacksonville, Fla., Bal was back on his feet, taking slow but steady steps as his granddaughter cheered from the sidelines.

To learn to walk again, Bal wore a medical exoskeleton called HAL (for Hybrid Assistive Limb) designed by the Japanese company Cyberdyne. In early 2018, the U.S. Food and Drug Administration approved HAL for use by clinics and medical centers in rehabilitating patients with spinal cord injuries. This Brooks rehab facility in Jacksonville started offering the first such treatments in March, and it’s still the only place in the United States where patients can find HAL.

Encouraged by the results they’ve seen so far, the Brooks staff plans to help Cyberdyne bring HAL to five more hospitals in the United States this year. Brooks is currently finalizing contracts to host and train visiting staff from those hospitals at their Jacksonville facility. Amy Morace, an exercise physiologist and business development specialist for Brooks, declined to share the names of its potential partners, but did say that one of the five new locations will be another Brooks facility in Daytona Beach, Fla.

For Bal’s recent session in Jacksonville, he wore a harness that kept him balanced over one of two treadmill tracks specially installed for use with HAL. As he thought about taking a step, his brain sent the necessary instructions to his leg muscles. But because of his injured spine, few signals made it through, and those that did were too weak to make his legs move, or to move with the swiftness and force of a normal step.

That’s where HAL came in. Nine electrodes stuck to each of Bal’s legs detected these faint signals and relayed them to the exoskeleton fitted to Bal’s legs. The exoskeleton’s control system read these signals to decipher Bal’s intent. Then, the exoskeleton assisted Bal in carrying out the movement he wished to make.

According to Cyberdyne, this process provides positive feedback to the patient’s brain that the intended motion was completed, which strengthens the signal pathway between the brain and the muscles, and ultimately helps patients learn to carry out the movements on their own, independent of HAL.

Other exoskeletons, such as ReWalk and the EksoGT, are programmed to take steps of a predefined length whenever wearers shift their weight, but they don’t generally improve patients’ ability to walk on their own—they must continue to wear the exoskeleton in order to get around.

And it isn’t easy to learn to operate them smoothly. “My experience is that it’s like you’re fighting against the robot,” says Javier Morales, a student at the University of Miami who is now taking a break from his studies to work with HAL at Brooks.

Traditional exoskeletons must also be recharged frequently, and can’t be worn out in the rain. They’re also expensive, costing between US $65,000 to $100,000, and are seldom covered by insurance.

Unlike those technologies, HAL did not complete any movements for Bal. Instead, once Bal had initiated a movement with his brain, HAL simply helped his muscles carry it out properly. “The difference is, we’re not just putting people through the motions, we’re strengthening a neurological command,” says Morace.

During a session with HAL, patients can monitor their progress on a screen in front of them that displays color-coded charts depicting the strength of signals detected in each of their leg muscles. Watching the charts helps patients gauge which muscles are involved in a movement, and how their ability to generate those signals is improving over time.

To Bob McIver, a physical therapist and director of technology for Brooks’s Cybernic Treatment Center, that biofeedback system sets Cyberdyne’s technology apart. “This really gave us insight into what message [the patient is] sending,” he says. “It really produces changes a lot quicker.” In future versions of the system, McIver would like Cyberdyne to do even more with this information—perhaps summarizing in a simple-to-understand “walking score” for patients, for example, or producing detailed reports for clinicians.

So far, the Brooks staff has screened more than 200 patients interested in working with HAL, and accepted 18 into its treatment program. Most of these patients have spinal cord injuries, though a few are being treated off-label for other neurological conditions such as Guillain-Barré syndrome. A typical program consists of sixty 90-minute sessions, conducted five days a week for 12 weeks, though some patients complete their treatment in fewer sessions.

It’s a grueling treatment regimen, often leaving patients feeling exhausted and sore. And the standard 60-session program costs $24,000 and is not covered by insurance; Bal asked his mother for part of his inheritance in order to pay for it.

Morace says that so far, seven patients have completed a full treatment program with HAL at the Jacksonville clinic. Aside from assistance with walking on their own again or with a walker, all seven have also reported at least two other benefits, which may include greater endurance, better posture, more control of bladder and bowel functions, and improvements to their respiratory system and/or cardiovascular health (such as lower blood pressure).

Brooks is currently leading a three-year research effort with 24 participants to quantify these results, and plans to expand its Jacksonville facility in 2019 to have as many as 12 tracks for HAL wearers to walk on.

When he started his treatment program, 31-year-old Morales could take only six or seven awkward steps at a time, even while wearing HAL. He suffered a devastating spinal cord injury 12 years ago in Spain when his friend lost control of the car he was riding in. After three weeks with HAL, he could walk for several minutes at a time while wearing the exoskeleton.

“I’m super happy because I’ve been fighting for so many years to produce these kinds of signals,” he says. “Today was good.”

Source: spectrum.ieee.org

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