Orlando Health Arnold Palmer Hospital for Children and Limbitless Solutions, Creator of Unique Bionic Arms for Children, Launch Clinical Trial

Aug 24, 2021 at 12:07 pm by pj


Limbitless Solutions (LSI) and Orlando Health Arnold Palmer Hospital for Children are launching a national study to evaluate the effectiveness of video game-based training aimed at helping children learn how to use prosthetic arms.

 

For the past seven years, LSI has 3D-printed prosthetics for children and uses video games created by University of Central Florida faculty and students to help prepare the children before they receive their arms. The new study with Orlando Health Arnold Palmer, known for its expert care of children and ranked by U.S. News & World Report in five specialties, will evaluate how well the video game helps the children prepare their muscles to use the LSI devices and how the role of gamified training may be used to improve the children’s rate of adopting the prosthetics long-term.

  

Prosthetics for children can be costly and those families who do get them often find that children may struggle to use them for very long for a variety of reasons, including weight and ease of use. LSI’s bionic arms are lightweight and are designed to reflect each recipient’s personality. However, it takes practice to use the arms, which is where the video games come in.

 

LSI, which is based at the University of Central Florida, is providing the bionic arms and video game training system. Orlando Health Arnold Palmer pediatric orthopedic surgeon Mark Birnbaum, MD, will serve as the principal investigator for the study. The hospital will also provide occupational therapists who will work with the children during the 14-month trial. This is the first Florida-based study for LSI.

 

“We are so grateful for Orlando Health’s commitment to support this research and children with limb differences,” said Albert Manero, PhD, CEO and co-founder of Limbitless Solutions. “It means the world that our hometown hospital is leading the study, and, with their support, we will be able to reach and connect with more families than we ever thought possible.”

  

The study will include up to 20 children from around the country, with an emphasis on recruiting in Central Florida, and is open to children ages 7-17 of all genders. There is no cost to participate, though funds to offset travel to the study sites at the hospital and UCF to meet with the study team are limited.

 

“Studies like this are an important step in understanding how we can improve the ways we care for children with congenital limb loss,” said Phillip Giordano, MD, corporate research operations chief, Orlando Health. “We’re excited to partner with Limbitless Solutions for this study and look forward to seeing what impact it has on families and children in Central Florida and beyond.”

 

For the first phase of the trial, participants will gain an understanding of how to activate the bionic arm’s multi-gesture controls by using Limbitless’ training mobile phone video game, Limbitless Runner, with a custom muscle sensing controller. The game helps prepare the participants to use their electromyographic (EMG) bionic arm at the two-month evaluation mark. While learning how to use EMG-powered technology can be complex, Limbitless Runner mirrors other video games by using designated levels where users will earn achievements and unlock more complex levels which correspond to muscle gestures needed to control the bionic arms.

  

The video games not only give children practice, but they are also a way to get beyond the social stigma surrounding limb differences. Research shows that people with a limb difference may experience stigma in their community which could lower self-esteem and contribute to an overall negative perception of their body image, whereby impacting their quality of life and psychosocial development. With the support of Orlando Health Arnold Palmer, Limbitless hopes to improve functionality and social acceptance for children living with a limb difference.

 

“We view our bionic arms as tools of empowerment and want our bionic kids to know they’ve always been complete and can achieve big dreams,” Manero said. “We want the bionic arms to be a powerful tool they can use. Orlando Health Arnold Palmer Hospital for Children’s decision to support our mission is truly one of the highlights in our organization’s history and we are so excited to take this next step with them here in our home of Central Florida.”

 

The study with Orlando Health Arnold Palmer is the first of its kind in the state of Florida and will benefit children nationwide. In 2018, Limbitless partnered with researchers at Oregon Health & Science University on a clinical trial that is wrapping up this year.

 

This is not the first time LSI has worked with Orlando Health. During the early stages of the COVID-19 pandemic, Limbitless shifted its operations and 3D printed more than 600 face shields and ear-savers to support Orlando Health and its frontline health care workers.

 

“We’re proud of our orthopedic research program for being chosen as one of only two sites to partner with Limbitless Solutions and the University of Central Florida,” said Mark A. Birnbaum, MD, Orlando Health Arnold Palmer pediatric orthopedic surgeon. “This project will provide a great groundwork for innovative changes in myoelectric devices and will impact function and quality of life for children with congenital limb deformities.”

Limbitless Solutions believes no person with a limb difference should be financially burdened to have a bionic arm and plans to provide prosthetics and training systems for the Orlando Health Arnold Palmer study free of charge. To learn more about the program and to submit an application to receive information about the study, families are asked to apply here: trials.limbitless-solutions.org.

 

Limbitless Solutions is a nonprofit and direct support organization at the University of Central Florida (UCF) dedicated to increasing accessibility and empowering children and adults in the limb difference community. Through personalized, creative and expressive bionics, provided free-of-charge, the team aims to empower using innovative technology and interdisciplinary collaboration to address accessibility issues. Limbitless develops muscle-based biosensing technology including multi-gesture bionic arms, a hands-free wheelchair control device and interactive video game training.

 

Founded in 2014, and located in UCF’s Research Park in Orlando, Florida, Limbitless combines engineering and art to promote access and engagement in STEAM learning experiences for a more inclusive future. Undergraduate students from various academic perspectives engage in project-based learning, professional development and research experiences where students put academics into practice in an environment focused on making a difference, as well as professional and technical development. Visit www.3DHope.com to learn more. 

 

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