Hands across the Ocean
January 2013 Issue
International Group Collecting Data On Multiarticulating Hands
After three years and six meetings on two continents, the Strategic Consortium for Upper-Limb Prosthetic Technologies (SCULPT) is set to launch its first international study of upper-limb prosthetic devices.
The study will involve myoelectric multiarticulating hands, devices that have seen phenomenal growth in the past five years with the advent of ever smaller, ever more powerful internal components. However, clinical research on these hands has not kept pace with these advances, according to John Miguelez, CP, FAAOP, president and senior clinical director of Advanced Arm Dynamics (AAD), headquartered in Redondo Beach, California. That's why he is leading this outcome-measures study, to prove whether the emerging upper-limb prosthetic technology does enhance a patient's experience and function.
There is limited documented data on prosthetic use, Miguelez says. "We want to study the amount of compensatory body movement required by multiarticulating hands compared to traditional prosthetic hands. A hand that decreases compensatory movement in the wrist, elbow, and shoulder should decrease the possibility of injury and increase a patient's function and time spent using the prosthesis, which should provide a better functional outcome."
The research group was in the process of identifying qualified patients for the study as this article went to press. The protocol requires a minimum of ten patients, but Miguelez says he would like to have 20 participate. A timeline for completion will be set once the participants are in place.
"It depends on the willingness of patients to commit to the study, as well as a commitment from the [patient's] facility to be part of the effort," he adds.
International Research Participant Base
The biggest challenge to recruitment is the limited number of eligible participants. Only about 10 percent of amputees in the United States are missing upper limbs, and of that 10 percent, about half choose not to use a prosthesis, according to a 2007 study by the National Institutes of Health. Even the 1,575 military service members returning from Iraq and Afghanistan without limbs are primarily missing lower limbs; fewer than 280 are upper-limb amputees.
This is where SCULPT comes in. With a half-dozen participating practitioners in Italy, Germany, and Norway, the consortium offers a larger prospective participant pool than would be available in any one country. It also offers a wider range of approaches to patient care and case management, which can provide another dimension to the research.
"We're able to do primary, evidence-based research that is more powerful using a multicenter, multi-country approach," Miguelez says. "And with many groups participating, the research load on any one facility is reduced, but the data is still strong."
AAD has partnered with INAIL, an organization that provides workers' compensation coverage and treatment to those injured on the job throughout Italy, to set up the study.
Annually, about 25 percent of the on-the-job amputations in Italy involve upper limbs, but that's only about 300 new patients per year, according to Andrea Giovanni Cutti, PhD, motion analysis lab manager and clinical trials manager for prosthetics at INAIL's Centro Protesi, which fits most of those cases. While the center has its own research and development department that evaluates new technology, Cutti says he looks forward to working with SCULPT on the multiarticulating hand study.
"It is a complex task to set up such studies, but it is worth the time," he says. "You have to look at function in daily living, psychological factors, and the impact of biomechanics on the rest of the body. The population available in one center is not huge, so many centers are needed to gather robust data."
The results of the study will allow prosthetists to evaluate and justify using one type of component over another, not only for patients who could benefit from an upgrade but also for insurers and others who need to know what they are getting for their reimbursement dollars.
One of the factors that has contributed to the difficulty in conducting prosthetic device research across multiple facilities is the competitive nature of the O&P industry.
SCULPT was created to provide a platform for physicians, engineers, occupational therapists, clinicians, and technicians to openly share their expertise in the field of upper-limb prosthetics. It was originally formed in October 2009 as Experts Meeting Experts by Ottobock HealthCare, Duderstadt, Germany, to explore how to create better outcomes for individuals with upper-limb amputations.
Today, in addition to AAD, INAIL, and Ottobock, participating SCULPT organizations include NovaVis, a pediatric amputee patient care center near Stuttgart, Germany; Norsk Teknisk Ortopedi, an orthopedic workshop near Hamar, Norway, that, like AAD, specializes in upper-limb prosthetic care; and the Rehabilitation Institute of Chicago, Illinois.
The first few meetings-the group has met in Berlin, Germany; Vienna, Austria; Dallas, Texas; Bologna, Italy; Chicago, Illinois; and Frankfurt, Germany-were mostly about building trust, Miguelez says.
"Once people understood what a huge advantage there is to collaborating, that it can lead to better outcomes, they were willing to share their technology and techniques," he says. "It gets really exciting when they agree to participate in studies and share the results and publish jointly. That just doesn't happen in the world of upper-limb prosthetics."
That's exactly why Cutti says he became involved in SCULPT. Although INAIL is a government entity, he says it is very good to compare practices in a non-competitive way.
"Clinicians from different countries have been very open to addressing difficult cases and sharing experiences," he says. "When we compare experiences with new prosthetic devices, we can see trends and similar issues that we face."
SCULPT meets twice a year, and proceedings are conducted in English. Between eight and 12 representatives from the participating organizations attend, according to Miguelez. Meetings begin with a presentation of a clinical case study by each group and discussion of possible approaches.
"What I've found valuable is seeing the different clinical approaches to patient management," he says. "The default control scheme is different in different countries. We've all learned a lot by asking, 'Why do you do it this way?'"
Multidisciplinary Patient Care
One issue that is addressed differently from country to country is the psychological impact of a new prosthesis. The usual approach in the United States is a series of casting/fitting appointments several weeks apart, and the patient is "lucky to see an OT before he's home for good," says Miguelez, who is a big proponent of incorporating occupational therapy (OT) in upper-limb prosthetic care.
Through its upper-limb prosthetic contract with Walter Reed National Military Medical Center, Bethesda, Maryland, AAD's multidisciplinary team is able to spend time training inpatient service members to use their devices while they receive OT and counseling.
Cutti says Centro Protesi also spends a lot of time training patients, both inpatient and outpatient, so they can better return to normal life.
"Treating patients requires a multidisciplinary approach, not just building a good prosthesis," he says. "It's important to address the psychological dimension. Without proper training, new devices aren't properly exploited. [If you provide] excellent OT, patients can integrate the [prosthesis] into their everyday life."
Cutti points out that his organization is in "a peculiar economic situation" with respect to new devices. Because INAIL is tax-supported, it can provide higher-priced components but still has to justify their use.
"We have to have experience so we can provide evaluation of what will be better for the patient's everyday life," he says. "Clinical trials are very important to better understand how to spend public money the best way to provide for patients. We need to put data together to orient our public policies to prosthetic policies."
Miguelez agrees that keeping abreast of all the new components and new technology is a lot of work. In fact, he feels that emerging technology is the foundation for the relationships that have been formed through SCULPT. While the clinicians want to have a clinical basis for discussion, the conversations are valuable for component manufacturers, too.
"Lots of manufacturers are caught in a paradigm of doing x or y, not what a patient really needs or what a clinical center needs to best help a patient," Miguelez says. "Data will help us have a united voice to express our needs to the manufacturers."
Kate Hawthorne is a freelance writer living and working in Fort Collins, Colorado. She can be reached at
Editor's note: For more information on SCULPT, read "International Clinical Think Tank Targets Upper-Limb Innovation," The O&P EDGE, December 2010.