Meta-analysis indicates safety of exoskeletons for ambulation

ReWalk Robotics Ltd. recently announced the publication of the reportedly first systematic review and industry-wide meta-analysis of published literature that assessed the clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injuries. A report summarizing the research was published in Medical Devices: Evidence and Research.

According to the report, “powered exoskeletons allow patients with [spinal cord injury] SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to yield health benefits.”

According to a company press release, researchers examined 14 published studies representing 111 patients and focused on ambulatory performance, physiological demand, health benefits and safety. Various powered exoskeletons were utilized in the studies.

The review found 76% of patients studied were able to ambulate without any physical assistance from another person following completion of the exoskeleton training program. In addition, routine use of the exoskeleton system offered health benefits, including improvement in muscle spasticity and bowel movement regularity.

“This expansive, industry-wide review of published data offers critical confirmation of the multiple documented benefits of powered exoskeletons for the SCI community,” Larry Jasinski, chief executive officer of ReWalk, said in the release. “We are pleased to see a growing acceptance and declaration of ReWalk and other exoskeleton systems as proven technologies with clear health benefits to customers. As the market leader in our industry, ReWalk will continue to work with the SCI community, health care providers and insurance providers, sharing the large body of published data to help support treatment and reimbursement decisions.”

According to the release, the study found additional health benefits of the use of powered exoskeleton systems included an increase of upper body muscular fitness, a slowed decline in bone mineral density by periodic exposure to gravitational and muscular loading forces, improvements in circulatory response and a counter to the independent health risks associated with prolonged sitting.

The researchers look to focus future research on the long-term health and cost benefits associated with chronic powered exoskeleton use to determine whether the initial expense of providing personal exo¬≠skeletons for home use to individuals with SCI — typically $70,000 to $100,000 — could be offset by the savings created through its health benefits and result in an overall savings to the health care system.

The analysis and systematic review did not identify any serious adverse events, according to the release, and reported a low rate of tethered falls and fractures addressed by subsequent refinements to exoskeleton design and patient selection criteria.

 

References:

Miller LE, et al. Med Devices (Auckl). 2016;doi:10.2147/MDER.S103102.

www.rewalk.com

 

Disclosure: Jasinski reports ReWalk Inc. provided support for the study, but had no editorial control.

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