Another significant aspect reflects health and quality-of-life benefits. Spungen said all 12 patients reported improvements in varying degrees – some had many benefits, some had only one or two – in terms of bladder and bowel function, fat tissue loss, reduction in pain and spasms, better sleep, less daytime fatigue, and better overall quality-of-life measures.
Spungen is the principal investigator of a new clinical trial, begun this year, to predict functional milestones reached by participants in an institutional-based exoskeletal-assisted walking training program, and to assess several likely medical benefits from regular use of these devices. The Department of Defense (DOD)-funded three-site study, the first controlled study in this field, includes the Bronx VAMC as the lead site, the University of Maryland Rehabilitation & Orthopaedic Institute, and the Kessler Institute for Rehabilitation as study data-collection sites. The study will use the ReWalk device and another called Ekso, currently seeking institutional approval. Spungen is also the chairperson of a 10-site nationwide VA Cooperative Study to investigate community-based exoskeleton-assisted walking to determine its benefits on quality of life and health.
One significant project is development of the hybrid orthosis system, which combines exoskeleton braces with electrical stimulation of muscles that results in body movement.
With that study now recruiting participants, Spungen said that one SCI research challenge is finding enough eligible individuals in any one geographic location, adding that this is a problem for all research for people with disabilities.
Spungen noted that recent FDA approval of the ReWalk has raised awareness of exoskeleton walking devices and heightened expectations of people with paraplegia, which in turn brings support for additional research funding and development of similar devices. “In the end, this progress equals hope and the prospect of walking for many who may have believed they would never walk again. And hope is always a good thing,” she concluded.
Neural Engineering
Researchers at the Advanced Platform Technology (APT) Center at Louis Stokes Cleveland VAMC, another center of excellence, are working to advance mobility and increase balance for those with SCI. “We have a number of projects that address primarily the motor limitations that occur after paralysis,” said APT Executive Director Ronald Triolo, Ph.D. “We are investigating different kinds of techniques to allow people to be more mobile, more functional in their wheelchairs, and to ambulate, climb stairs, or function in unadapted environments; to get back into home and community situations with a minimal amount of assistance.”
One significant project is development of the hybrid orthosis system, which combines exoskeleton braces with electrical stimulation of muscles that results in body movement. “The main concept is that this approach doesn’t utilize any external motors at all,” Triolo said. “We call it a ‘muscle first’ strategy.” He explained that if the peripheral nerve that connects the spinal cord to the muscle has remained intact, stimulation of the peripheral nerve with a tiny electrical current elicits contraction of the paralyzed muscle.
“Electrical activation of the peripheral nervous system is really good at generating large, propulsive forces out of the paralyzed muscle, and we use the contractions of the person’s own musculature to drive the standing and walking and stair-climbing movement rather than relying on an external motor,” he said.
The electrical current can be delivered through surface electrodes or through implanted, pacemaker-like stimulation systems. “There’s a control system that runs the brace, there’s a control system that coordinates stimulation, and there’s a coordinating system that makes sure that both of them work together, that they’re not at cross-purposes,” said Triolo. “Essentially, the brace has sensors on it that detect where you are in the gait cycle and then start the stimulation appropriately. But that stimulation can change the orientation of the brace, so both systems have to know what they’re doing. That’s why we call it a hybrid system – it’s a combination of stimulation and bracing.”
Triolo said this DOD-funded project was geared toward streamlining the external hardware and untethering it from the laboratory computer to operate in a self-contained mode, which was recently accomplished when it was used outside the lab in hallways. “We’re looking forward to actually getting this out of the laboratory and into the community, and putting it through its paces to see if it’s really going to be functional for people,” he said.
Because a large number of people with SCI depend on wheelchairs, APT Executive Director Ronald Triolo, Ph.D., is enthusiastic about work they’re doing that uses muscle-stimulating technology to help stabilize people while they’re seated in wheelchairs by stiffening the hip and trunk muscles.
In addition to continuing development of the hybrid orthosis system, other APT research involves extending the reach of that technology to patients with incomplete SCI, as well as to stroke survivors and those with multiple sclerosis.
Researchers in Cleveland are also using the implanted technology developed through the VA and Case Western Reserve University to help people stand without braces for long periods, with emphasis on standing balance, and exploring new kinds of electrode technologies through various projects funded by the VA and the National Institutes of Health.
Because a large number of people with SCI depend on wheelchairs, Triolo is enthusiastic about work they’re doing that uses muscle-stimulating technology to help stabilize people while they’re seated in wheelchairs by stiffening the hip and trunk muscles. This aids sitting posture and balance and allows them to propel their manual wheelchair more effectively and with less incidence of shoulder injury, a common pathology in wheelchair users.
Triolo said his message to paralyzed veterans is “to have faith that the VA and other researchers are working hard to develop technology that will address their most pressing needs in terms of exercise, daily function, personal mobility, and that these things are on the cusp, if they’re not already on the market like ReWalk, of being clinically viable. There are lots of opportunities to get involved in this translational research to help refine many of the new sophisticated and life-enhancing technologies that, in the near future, will be widely available to improve the overall health and capabilities of people with SCI.”
For additional information, visit the Advanced Platform Technology (APT) Center, the Cleveland FES Center, or the U.S. National Institutes of Health’s clinical trials page.
This article first appeared in The Year in Veterans Affairs & Military Medicine 2015-2016 Edition.