Edina-based med-tech startup RxFunction says a pilot study of its experimental Walkasins medical device has documented meaningful improvements in patients being able to walk normally despite a permanent loss of sensation in the legs.
“Using Walkasins more than doubled the proportion of patients who showed a meaningful improvement in clinical outcomes related to gait and balance,” Dr. Lars Oddsson, president of RxFunction, said in a news release about the study results.
The device is intended to help people with a condition called peripheral neuropathy learn to walk safely again. It includes foot pads and CPU that sense how the wearer’s weight is distributed, and vibratory devices strapped to the ankle that fire to tell the wearer to adjust their balance or gait. The device is considered a “sensory prosthesis” for the legs.
Neuropathy affects millions of people with diabetes, as well as veterans exposed to Agent Orange. The recently completed study randomized 31 veterans at the Minneapolis VA Hospital to short sessions in which they tried with the device turned on or off, and then after a short break, tried the experiment again with the device off or on. The full results of the IRB-approved will be submitted to a peer-reviewed journal soon.
Interim results presented at the Design Medical Devices Conference in Minneapolis this summer showed patients using the device had an average improvement of 4 points in the Functional Gait Assessment test, compared to patients whose Walkasins were turned off. FGA is a metric that scores walking ability from zero to 30; average FGA scores for device users increased from 18 to 22, the data show.