Standardization News

Imagine being able to give a paralyzed veteran the ability to walk again. Or being able to transform the life of a child with cerebral palsy.

These hopes are driving the innovators and clinicians working to develop exoskeletons for medical applications. Recent advances have seen "wearable robots" become more commonplace in industrial settings, giving users greater strength and endurance. But interest is growing in their potential for the field of healthcare, where the technology can have life-enhancing results for patients with impaired mobility.

Kendra Betz is a physical therapist at the U.S. Department of Veterans Affairs (VA), who specializes in working with veterans with severe disabilities as a result of illness or injury. With extensive national experience with adaptive equipment and assistive technologies provided to veterans, she has a strong interest in exoskeleton and other advanced assistive technologies that can help patients get back to what’s most important to them. “When you work with individuals with severe impairments, they need the most advanced technologies to allow them to participate at home, at work, in recreation, whatever they might want to do," she says. "We as clinicians are supporting our clients to gain as much independence and autonomy as possible.” 

More Freedom to Move

Currently, most medical exoskeletons are used in clinical settings for rehabilitation. The first exoskeleton for walking rehabilitation was cleared by the FDA in 2014. Some FDA-cleared devices are intended for use in clinical settings under the direct supervision of a trained therapist, while others are for personal use beyond the clinic. Exo devices can help someone to regain walking skills or allow them to stand and take steps when other options aren’t available. Exoskeletons sometimes offer more freedom than traditional devices used for gait training like parallel bars, treadmills, or overhead support systems, allowing patients to move across different settings and different distances without needing additional equipment other than crutches. They can also provide a significant psychological boost. As Betz explains, “When an individual sustains a significant illness or injury, there’s always a motivation to get back to standing and taking steps or walking. Many people enjoy the opportunity to stand and be at face level with other people and experience something that they view as more ‘normal’ than sitting in a wheelchair.” 

Therapists may also benefit from using exo devices. Matthew Marino is a physical therapist and ergonomist with expertise in rehabilitation and wearable technology, and a founding partner of the ASTM International Exo Technology Center of Excellence (ET CoE). “I've worked in settings and hospitals where we have two, three, four therapists at a time helping a patient learn to walk again," he says. "It's back-breaking work. So these technologies not only help improve the rehabilitation of a patient, they’re also a tool for therapists that makes life easier and improves the quality of the care that they're providing.” 

Taking the Clinic Home

For Marino, however, where things really get exciting is when the device can be used outside the clinic. Marino’s interest in exo technologies took on a personal dimension when his son was born with cerebral palsy.

“I became interested in what the future will look like in regards to technology being able to augment, enable, assist, or enhance his life. When a child has a unique window of opportunity to engage in meaningful and effective rehabilitation, it can be absolutely life-changing. An exoskeleton for somebody like my son would be like wearing a physical therapist.”

Taking the clinic home in this way could help children learn to move in ways that don’t increase the risk for other types of pain and injury, and build rehabilitation into their normal activities and routine. 

Safety and Performance

Some ‘wear at home’ devices are beginning to appear on the market, but it is early days for pediatric models, as well as for adult exoskeletons for use as everyday mobility aids. Marino and Betz are keen to see advances, and this has motivated their work with ASTM International. The ET CoE and the committee on exoskeletons and exosuits (E48) are developing standards for the safety, quality, and performance of exo devices. When these are being used for rehabilitation, or by a disabled person, some of these standards may take on added significance. Betz gives the example of battery life. “We need to have a guarantee that the battery is going to sustain itself for the application that is being used for and have an indicator of when the battery is running low – just like in a vehicle," he says. "If someone is using an exo device to allow them to walk, and the battery dies when they’ve moved away from their wheelchair, then you’ve got a real safety issue.” 

Part of the work being done by F48 and the ET CoE is supporting the networks and knowledge exchange that are needed to ensure innovations can be translated into successful, real-world products.

“It's not just advancing the technology, but really advancing the application of technology,” says Betz. “There's often a disconnect between research and development and innovators, and clinical care. We need to bridge the gap between how devices are designed and how they work with the clinicians and the people that are using them.”

If exoskeletons are too difficult to use; can’t integrate with other technology or equipment that patients are using; or need the user to have a companion with them, they are likely to be abandoned.  

Feedback for Innovation

Greater involvement from the healthcare community is key, says Marino, and will be supported by a medical practitioner survey that was recently fielded.

“We want to understand: 'Who are the medical professionals using these devices? What types of patients are they using them with? What is their experience?' It’s about telling their story and understanding their needs. That’s going to help us collaboratively build the standards so that new technologies can meet the needs that aren’t being met right now.”

Making products usable by a broader group of people and ensuring that the benefits can be measured objectively and documented will also, they believe, help grow the market and attract investment to fuel further innovation.   

Betz draws a parallel to a more established assistive technology: the manual wheelchair. “Until around forty years ago, the only wheelchairs we had were heavy, folding models that were non-adjustable and difficult to use. The ones we have now are customized, lightweight, and really high-tech. By evaluating exo devices in the same way and supporting different people to trial them and provide feedback, we can provide recommendations to support continued innovation in rehabilitation.”

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