Building a Better Brace

John Harvey is an active 8-year-old with spina bifida, who gets around pretty well right now with the help of braces, crutches, and a wheelchair. But he’s a growing boy and his parents have their eyes on the future, and they wonder about the tools he’ll use to help him along his evolving path from Point A to Point B.

“We’re concerned with the challenges he’ll face as he gets older and taller,” says his mom, Stephanie Harvey of Atlanta. “The last thing we want to do is inhibit him.”

“He needs functional tools that grow with him,” adds his dad, Stu.

With that in mind, last summer the Harveys contacted the BME Capstone program at the Wallace H. Coulter Department of Biomedical Engineering (BME) at the Georgia Institute of Technology and Emory University.

Every semester through the Capstone program, BME seniors experience all aspects of product development, with an emphasis on medical devices, working towards the goal of producing functional prototypes to address the needs of a wide range of users. For the Fall 2017 semester, one of those users was John Harvey. Turns out, the Harveys already had a connection with Tech.

“At one point, all four of our babysitters were Georgia Tech seniors or graduates, and one of them knew all about the BME Capstone program,” says Stu.

So they contacted program director James Rains, then submitted their project proposal and soon made a new group of talented friends in BME seniors Zinka Bartolek, Renee Copeland, Samantha Houser, Davira “Tia” Widianto, and Brice Williams.

Perfect Fit

The students had “a bunch of projects to consider,” says Houser, but they quickly discovered that their goals and skill sets converged perfectly with the Harveys’ interests.

“John’s family was frustrated with some of his bracing solutions. They weren’t providing him with the mobility they’d like to see,” says Houser who, with her teammates, graduated following the fall semester. “This was a great fit for us.”

Williams, who like most of his teammates is planning on medical school, adds, “one of the main reasons this project appealed to me is, I’d like to go into pediatrics. This gave me a glimpse into that world, and the challenges in pediatric medicine.”

So, with the coordination of Children’s Healthcare of Atlanta, the BME seniors and Harveys joined forces. The team spent about two months doing interviews with the Harveys, with John’s physical therapists, his orthotists, other professionals and patients they met through the Spina Bifida Association of Georgia, which sponsored the annual Walk n’ Roll for Spina Bifida on the Georgia Tech campus in October.

The timing of that event was fortuitous. Copeland – a former Petit Institute Undergraduate Research Scholar – was researching spina bifida and happened to read about the 12^th annual Walk n’ Roll. “And then we had two weeks to get everything ready, but it was really lucky for us, because we were able to get a lot of user interviews done that day,” Copeland says.

“By that point, we’d already sketched out almost 100 design iterations,” says Widianto. “We let the families that were there offer feedback, write down what they liked, what they didn’t. We had a lot of sticky notes.”

They gathered all of that data and gave it to the Harveys, who consulted with John’s therapists and orthotists, to pick a final design.

Brace for Awesomeness

Pediatric medical devices, like the knee-ankle-foot orthosics (KAFOs) John uses, can do wonders, but they are limited in few ways: They don’t grow with a child’s maturing body, and they don’t promote proper balance or natural ambulation, which can lead to bone growth issues down the road.

So the team’s mission statement was, “improve ambulation of pediatric spina bifida patients through a novel orthotic solution that allows knee mobility during walking while supporting the user’s weight, without deforming.” With that goal in mind, young John gave the team a name: Brace for Awesomeness.

When John wears his standard device for ambulation, it has to be locked in a fully extended position for structural support, but this results in an unnatural gait. The team’s final prototype, WalkSense, is a pressure sensor calibrated device that controls the locking state of the knee based on the walking cycle. WalkSense sends a signal from the heel of the KAFO up to the knee to a locking device.

Brace for Awareness unveiled its prototype at the fall edition of the Capstone Design Expo in December, when 136 teams put their work on display, (including Liv’R Little, which won in the BME category at the expo).

“We had a chance to show off what we’d done and where we’d been,” says Houser. Over the course of several months, the team became like members of the Harveys’ extended family, going to dinner at the house, going to doctor’s appointments, physical therapy.

“They truly took time to get to know and understand John and our family – they really went above and beyond,” Stephanie says.

Big Night, Big Hopes

It all came together at the Expo. The team used videos, a large poster, and the prototype to tell the story of their Capstone journey.

“The highlight of the night was showing the Harveys the device, and seeing the excitement in every single member of the family, including all three of the children,” says Copeland, the former Petit Scholar who’d been named Ms. Georgia Tech just weeks before the Expo. “Every family member played a part in the process, and it was exciting to see their reactions, and imagine what the final version of this device might be, and what it would mean to John.”

Their product, the WalkSense, was only a prototype and not ready for regular patient use yet, “but it’s definitely a prototype that can be leveraged into the next phase,” Stu believes.

It’s a work in progress, and the family has been discussing the future possibilities with John’s regular care team of physicians, therapists, and orthotists. The family is thinking long-range, with visions that extend beyond their own experience.

“When I think about my son’s life, the surgeries he’s had, and later, the medical devices, someone had to pave the way,” Stu says. “Our goal is to see if something could be developed to help John, but also to help the children like him 20 years from now.”