The BADER Consortium may be officially housed in the Health Sciences Complex on the University of Delaware‘s STAR Campus, but much of its work takes place at military treatment facilities and academic institutions across the country.
Its role—funded through a nearly $20 million grant from the Department of Defense (DOD)—is to support
orthopedic research that helps service members with limb loss or limb difference return to optimal function.
Far from being housed in one place, BADER’s geographic blueprint stretches from the First State to California, with stops along the way in Maryland, New York, Massachusetts, Rhode Island, Minnesota, Colorado and Texas.
Among the eight studies BADER is funding are a virtual-reality training program to increase stability when walking; biofeedback strategies for improving walking and running; and identifying the optimal stiffness and height of a running prosthesis.
But BADER also is having an impact here in Delaware, the result of a new partnership with a local prosthetics company to help civilian patients who want to optimize the fit and function of their prosthetic devices.
The BADER Clinic, operated in conjunction with the UD Physical Therapy Department and Independence Prosthetics- Orthotics, has seen a handful of patients in its first weeks. The clinic operates with a multidisciplinary approach that involves clinicians, researchers and patients working together to determine the best approach when it comes to prosthesis design and fit.
Already, it shows the potential for improving patient outcomes through collaboration and innovation, said BADER Consortium Director Steven J. Stanhope.
“We’re trying to rewrite how we look at functional outcomes in prosthetics and orthotics by involving students, faculty, industry and other experts,” Stanhope said. “We want to take advanced technologies and see how they are best suited for which level of functioning. We want to be that bridge to see the highest level of functioning from patients.”
Bridging advanced developments for exceptional rehabilitation Stanhope’s bridge analogy is a good one to describe BADER, which stands for Bridging Advanced Developments for Exceptional Rehabilitation. It began in 2011 when BADER was awarded a five-year, $19.7 million grant from DOD to strengthen evidence-based orthopedic rehabilitation care for soldiers with musculoskeletal injuries to help them return to optimal function in their daily lives.
The award was made through DOD’s Office of Congressionally Directed Medical Research Programs, and the idea was to bring together military treatment facilities, academic researchers and rehabilitation centers for the benefit of the nation’s wounded service members.
Over the past 13 years, more than 1,500 members of the U.S. Armed Forces have suffered a traumatic injury requiring a limb amputation as a result of the conflicts in Iraq and Afghanistan. Only about 17 percent of soldiers with amputations return to active duty—an improvement from about 2 percent in the 1980s.
In many ways, their needs are different than the typical civilian population, in part because of their younger ages, severity of injury and their activity levels prior to getting hurt.
Marilynn Wyatt, a BADER-funded researcher and director of the Gait Analysis Laboratory at the Naval Medical Center in San Diego, Calif., said many of these patients have high expectations of what they’ll be able to do once they’ve been fitted with a prosthesis. But returning to an active lifestyle is not always that easy.
“They were in great shape and athletes when they were injured,” said Wyatt. “Once they’re put back together orthopedically, they want to do high-functioning activities. They accomplish walking early on in their rehabilitation. They want to do more.”
These kinds of projects are asking ques- tions that haven’t previously been considered in prosthetics research, Stanhope said. Rather than assuming a patient will be happy reaching some kind of basic function with their prosthetic device, these researchers are looking at how this technology can be used to improve athletic ability—perhaps in helping someone reach even higher functional levels than expected—or reduce their risk of future injury.
Research also is needed to learn more about the long-term impact of a prosthesis on the rest of the body, particularly as these devices become more advanced, said Alena Grabowski, a BADER-funded researcher at the University of Colorado who is looking at the stiffness and height of running prostheses.
“There’s a lot more going on in an intact limb than a prosthesis. It’s very challenging comparing apples and oranges,” she said. “As scientists, we’re trying to understand both.”
Assisting military treatment facilities in transforming care Stanhope said the BADER Consortium builds on UD’s solid foundation in biomechanics and rehabilitation while leveraging relationships with other
national experts to create a framework supporting orthopedic research with the potential to transform care for patients with limb differences.
Housed within BADER are several cores that provide administrative, clinical research and scientific assistance to military treatment centers and affiliates. The administrative core is similar to the one found in the Delaware INBRE program, which is funded by the National Institutes of Health (NIH) to enhance the region’s biomedical research capability.
It’s a program Stanhope knows well— he worked at NIH for 22 years and now directs the Delaware INBRE program, which recently received a $23.2 million renewal.
“It was a matter of marrying that NIH model system with the world-class status of the UD biomechanics and movement science program,” he said. “We wanted to create something like that for the DOD.”
In addition, BADER also includes a clinical research core with UD employees who are located on-site to support and assist with the research going on at the participating military treatment facilities—Naval Medical Center San Diego in California, San Antonio Military Medical Center in Texas, Naval Medical Center Portsmouth in Virginia and Walter Reed National Military Medical Center in Maryland.
The consortium was the first in the nation to partner with the National Institute for Child Health and Human Development to use its clinical trials database outside the confines of the federal agency. The BADER Clinical Trials Database, or CTDB, mirrors the NIH database—though it operates externally—and offers affiliates an opportunity to access a controlled central repository of data. It can be used for multi-site protocols or individual research teams and is protected by a secure firewall.
Working in conjunction with the CTDB are the biomechanics, biostatistics and outcomes measurement cores, which further bolster research capabilities at the sites.
Mayo Clinic researcher Kenton Kaufman, who oversees BADER’s scien- tific cores, said the consortium brings together the work being done by the military treatment centers on a larger scale. Although each facility has a method for collecting data, BADER helps pool that data, in part thanks to the CTDB.
“We’re bringing together groups of people that can look at improving the outcomes of people who have had military injuries,” said Kaufman, director of the Biomechanics-Motion Analysis Laboratory at the Mayo Clinic. “One of the strengths of BADER is the infrastructure it has developed. We make it possible to do clinical studies on combat-relevant patients.”
At Naval Medical Center San Diego, BADER has embedded two positions into the core staff, Wyatt said. One is a funding protocol coordinator and another is a limited-term researcher, both of whom are on-site and working on the projects.
“BADER is unique in that its purpose is to support us—to facilitate and help the research,” Wyatt said. “That has been a huge help.”
The need for ways to treat
new war injuries
Despite the national reach of BADER, there have been some recent additions in Delaware that offer the potential to strengthen an already robust program.
One is the recent hire of David Tulsky in UD’s College of Health Sciences. Tulsky, an expert in outcomes assessment research, joined UD’s Department of Physical Therapy and is working with
the Center for Translational Research ACCEL program.
Tulsky already serves as director of the Rehabilitation Outcomes Measurement (ROM) Core for BADER. He works with principal investigators to recommend outcome measures for their projects, provide training in the use of these measures and develop new measurement platforms for research.
Among the BADER-funded projects Tulsky is currently working on is an outcomes toolbox to identify common data elements at multiple military treatment facilities.
“There are new injuries with these wars that have surprised the medical community. One thing we have to do is develop ways to treat these signature injuries, which include traumatic brain injuries and amputations,” Tulsky said.
A collaborative approach can help drill down on some of these challenges, said Wyatt, who is working with Tulsky on the toolbox project. In many cases, though, it’s a guessing game, particularly when it comes to the long-term effects of using these prostheses.
“We’re all concerned about and don’t know the secondary effects,” Wyatt said. “For the opposite limb, we know there’s increased forces. Is there also osteoarthritis and back pain? These new prosthetics are allowing our patients to be more active and is that increased activity leading to secondary effects or, in fact, preventing them? We don’t know the answer.” A clinic for civilian patients
The opening of the BADER Clinic at STAR Campus also offers an opportunity for civilian patients to access interventions and collaborations that can help them reach individual goals, whether it’s to be faster, feel more secure or get around more easily with their prosthetic device.
“Patients enter the clinic by expressing a goal. The goal is to get a higher level of function,” Stanhope said. “The ticket to this specialty clinic is that they have to express and demand this. The want to
Patients so far have been referred to the clinic through Independence Prosthetics-Orthotics, which has a lab location outside Newark. Owner John Horne works with BADER staff, UD physical therapy clinicians and other researchers to learn more about patient needs and challenges they may be facing.
Information captured through motion analysis inside BADER’s treadmill lab— where cameras capture the movements of patients walking or running on the split-belt instrumented treadmill—helps Horne and his staff make changes to improve patient function and comfort.
So far, the approach seems to be working for Ashly Ash, who was recently fitted with a new prosthesis specially designed to be more functional for her type of higher-level amputation. She is the fourth patient to visit the BADER Clinic, and she credits the streamlined approach with changing her own expectations of what’s possible.
“Before this, you’re going to this doctor and that doctor and they don’t necessarily talk to each other. It’s all on the patient to handle everything,” said Ash, who is missing three joints as a result of her amputation.
Horne, with funding assistance from BADER, arranged for a national expert on Ash’s type of amputation—known as hip disarticulation—to visit Newark and demonstrate a new model for making a prosthesis. After it was made, Ash walked on the treadmill at the BADER Lab and underwent further tweaking by staff.
She said the experience was unlike any she had before. Stanhope said it highlights what’s possible to help patients reach their optimal level of function.
“It’s really a one-stop shop. I think it will really make a precedent for the way health care is handled for amputees,” she said. “It’s so much easier going here and having everyone connect.”