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VA Research Currents archive
May 11, 2017
By Mike Richman
VA Research Communications
Research participants try out the ReWalk at the Bronx VA Medical Center during a visit by Lt. Gen. Thomas Travis, Surgeon General of the U.S. Air Force. (Photo by Lynne Kantor)
Gene Laureano's life changed forever on Nov. 11, 2001.
That day, he stood at the top of a 20-foot ladder while trying to repair a canopy in New York City. The ladder slipped from the bottom, sending the 6-foot-3, 210-pound Army Vet plunging to the ground, where he landed on his back.
With his upper body twisted to the side, Laureano tried to get up but realized he couldn't move his legs. He immediately thought he must be paralyzed, a reality confirmed by doctors who performed surgery on him in the hospital. They also told him he'd never walk again.
Laureano didn't believe it: "I was like, 'I'm going to walk again. I don't care what these doctors say.' "
Today, Laureano, 54, is paralyzed from the navel down. But he's back on his feet thanks to a wearable robotic exoskeleton that facilitates upright movement. The device he uses is touted as the most customizable exoskeleton on the market: the ReWalk 6.0 made by ReWalk Robotics. The computer-controlled product provides powered hip and knee motion to help paraplegics stand upright, walk, turn, and climb and descend stairs. Someone must be near the user at all times; Laureano's wife is next to him when he walks.
At the same time, much remains unknown about the Israeli-made apparatus. More needs to be understood about its benefits and who's best suited to use it.
"This clinical trial is groundbreaking in both purpose and scope."
That's why VA researchers are performing a nationwide study to learn much more about the ReWalk 6.0 and its impact on quality of life. A total of 160 paralyzed Veterans with spinal cord injury are being enrolled at 10 VA medical centers to participate in a four-year study. Enrollment is expected to be completed in August 2020.
The trial, funded by the VA Cooperative Studies Program, is the first to examine the impact of the exoskeleton on home and everyday life. Researchers will evaluate the technology's ability to improve the mental, social, and physical health of Veterans, and whether it helps them overcome bladder and bowel management difficulties. In prior VA studies, the exoskeleton was used in environments such as walking down the street, in buildings, and at events, but it was returned to VA at the end of the day.
Dr. Ann Spungen, associate director of the Center for the Medical Consequences of Spinal Cord Injury at the James J. Peters VA Medical Center in the Bronx, New York, is leading the trial. She says not everyone with spinal cord injury is eligible or even interested in using an exoskeleton, which has specific requirements.
A user of the 51-pound ReWalk 6.0, for instance, should be about 5 feet 3 inches to 6 feet 3 inches tall and can weigh no more than 220 pounds. One must also have adequate bone density to reduce the risk of fracture, limited muscle spasticity to permit coordination with the device, the ability to hold crutches or a walker, and the availability of a companion should a problem arise.
"We know very little about the characteristics of who is a good candidate, and who will be a safe and competent user of this technology," Spungen says. "We do not know how long it will take for them to become skilled, how many have available companions, or when, where, and how often they will use the device in their home and community. We hope to learn the answers to these and many more questions in this trial."
Some exoskeletal-assisted walking studies are underway at non-VA rehab hospitals around the world, but only VA is performing a home-use study of the technology, Spungen says.
The Bronx VA has been VA's leader on exoskeleton research. Its efforts began with a pilot study that analyzed the effects of exoskeletal-assisted walking, with 12 paraplegic individuals taking part in dozens of sessions with the ReWalk 6.0.
The researchers saw much progress in the participants' walking and mobility skills, as well as improvement in fat mass loss, lean tissue mass gain, better bowel and bladder management, and less back pain. All 12 people also reported "feel good" emotions over being upright and mobile, according to Spungen.
"Our research team felt these findings were worthy of a large, multi-center study," she says.
Dr. William Bauman, director of the Center for the Medical Consequences of Spinal Cord Injury, is co-chairing the study with Spungen. He says the exoskeleton's impact on bowel and bladder function in the nationwide trial is of major interest to the researchers.
Bauman is almost certain any improvement in bowel function through use of the exoskeleton is due to the user's ability to walk.
"In an exoskeleton, where you have the pattern and the forces brought to bear on the leg and on the body that mimics sufficiently the act of walking, the gut improves in bowel motility," Bauman says. "Why this occurs, I don't know, but if you're in bed, your bowels will not work very well. But if you get up and get moving again, they will kick in. The bowel has a separate nervous system from the brain and spinal cord....That nervous system is affected by motion to cause it to, if you will, come alive and improve bowel function."
The exoskeleton's effects on bladder are more ambiguous, according to Bauman. The researchers did not expect to find bladder improvement in the pilot study, but the participants consistently indicated that their ability to prevent bladder accidents, such as episodes of urinary incontinence, appeared to get better, he says.
"We haven't investigated why this occurs," Bauman says. "But there are investigators who suggest that if you have body stimulation, stimulation to the legs, that there are nerve impulses that travel to the bladder that will prevent the bladder from emptying at unwanted times."
In the nationwide study, an intervention group of 80 Veterans who are trained to use the ReWalk 6.0 with their companions will take it home for four months. They will be compared to a control group of 80 Veterans who will rely strictly on wheelchairs during the same period. Both groups will answer questions at the two- and four-month marks that will mainly be used to assess quality of life and disease burden, or how a health problem relates to factors such as financial cost.
Spungen theorizes that one-third of the intervention group will experience "clinical meaningful net improvements" during the study, compared with 10 percent of the control group.
The Veterans will answer questions relating to general health perceptions, bowel and bladder management, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy and fatigue, social participation, and emotional factors such as anxiety, depression, and self-esteem.
The study team will also evaluate changes in body composition, including fat loss and muscle gain, as well as sugar and cholesterol levels in the blood. An improvement in metabolism—or processes in the body that create the energy to keep one going—would help reduce the risk of cardiovascular disease.
"Because people with spinal cord injury are immobilized and have adverse changes in body composition, this can affect general metabolism," Bauman says. "It can affect energy, sugar, and cholesterol.
"Good cholesterol, the HDL cholesterol, is sensitive to activity," he says. "So if you're a marathon runner, your HDL cholesterol on average, depending on your genetics, would be higher. If you're a couch potato, your HDL cholesterol would be lower. In someone with spinal cord injury, the HDL cholesterol, which is a pretty good indicator of risk for cardiovascular disease, can be remarkably low."
ReWalk Robotics CEO Larry Jasinski is optimistic the study will bring to light new and important information on the exoskeleton.
"VA's study will expand the understanding of community use and allow for more definitive data on the specific health benefits that may occur from walking at home, work, or socially on a regular basis," Jasinski says. "This clinical trial is groundbreaking in both purpose and scope, and it will undoubtedly add a wealth of quality research data to [VA's] already impressive research."
In 2014, the U.S. Food and Drug Administration approved the ReWalk 6.0 for home use. The organization Paralyzed Veterans of America subsequently asked VA to pay for the $77,000 apparatus so they could use it at home. The agency agreed to do so in 2015, marking the first national coverage policy for robotic legs in the United States. VA has since placed 14 ReWalk 6.0 exoskeletons in Veterans' homes, Jasinski says.
Gene Laureano, who is allowed to take one home, has been using the ReWalk exoskeleton series for four years. He has seen positive effects, including lower blood pressure and the ability to consistently have more regular bowel movements. He struggled to move his bowels while only using a wheelchair, sometimes becoming constipated and having accidents. But he says being in an upright position for several hours a day with the exoskeleton has made the process much easier. His diet includes a lot of high-protein foods.
Plus, Laureano says his self-esteem has gone "through the roof" since he's been able to walk. He credits the exoskeleton with giving him a "second chance."
"I started thinking that maybe I don't have to just exist in a wheelchair, maybe I can participate in life," he says. "I joined a support group and a hand cycle team, I'm a certified scuba diver, and I've been sky diving and playing adaptive softball. I think all of that came from the ReWalk. It just opened doors for me mentally."
He plans to participate in the "Hope & Possibility 4M" in New York City on June 25. The four-mile run brings together athletes with disabilities and those who are able-bodied.
Paralyzed Veterans of America (PVA) estimates there are 100,000 American Veterans with spinal cord injury or disease. PVA Executive Director Sherman Gillums Jr., says all "properly functioning exoskeleton devices are a godsend to Veterans who enjoy restored mobility." But he voices a cautionary note about the technology, saying it is in its "infancy, so restrained optimism is in order."
Gillums, a former Marine who was paralyzed in a car accident in 2002, has considered using a robotic exoskeleton.
"It can be easy to oversell the exoskeleton as a panacea for all Veterans who live with paralysis," Gillums says. "Doing so would serve to toy with the hopes that many Veterans carry when learning of an alternative to wheelchair use. That said, I am anxiously awaiting the results of the [VA] research and what it will portend for present and future paralyzed veterans."
He adds: "Members of Paralyzed Veterans of America place an extremely high premium on independence and freedom of movement above all else. Right now, exoskeletons can stand Veterans on their feet and help bring about the sense of completeness that accompanies standing on one's own feet. But everyday life is full of uncertainties that have yet to test the application of the device under all routine, and some non-routine, circumstances. Before we had iPhones, cellular phones were the size of a small Army field radio at one point. I think the best is yet to come, and someday these exoskeletons will totally change the way we view disability."
Laureano agrees. He's seen the ReWalk advance in quality and convenience since he began using it. He says engineers have told him they're working on making the technology so light that it will someday fit under one's clothes.
"I tell people that when I when I woke up in the hospital, it was simply put, 'You're never going to walk again,' " he says. "Now, the doctors can tell a person, 'Listen, you're paralyzed but here's an option.' So I think that in itself gives a person a better sense of hope to have as close to a normal life as possible, as opposed to sitting in a wheelchair and worrying about bed sores all the time. The ReWalk has kind of opened up my mind to dare to think of trying this and trying that."
Video: Watch Gene Laureano use the ReWalk outside the Bronx VA Medical Center.