Fox News National article, by Melinda Carstensen, Fox News Health Editor
Wearable technology may improve sleep, endurance and chronic pain
Sixty-three-year-old David Baker made a living driving tractor trailers in the South for 40 years. But when he was diagnosed with Parkinson’s disease in 2006, the condition meant the days he could still operate the equipment, much less walk without stumbling, were numbered.
Baker went on disability two years after his diagnosis, at which point he began to rely on a walker. Today, however, Baker can stand strong, most often without assistance— a capability due in large part, he said, to a bracelet infused with pulsed electromagnetic field therapy (PEMFT) that he has worn since 2013.
Baker is one of about 30,000 people worldwide who is using the device, which was created by Ponte Vedra Beach, Fla.-based company Active Edge. PEMF works by pulsing electromagnetic waves through the body to increase blood flow and reduce inflammation. PEMFT has been approved for use by the Food and Drug Administration (FDA) for decades, but Active Edge said its products are the first to offer these health benefits via wearable technology.
Gainesville, Fla.-based InBalance Technologies created the specialized PEMF technology that can be infused into fabric, and began collaborating with Active Edge CEO and founder Kurt Walchle after being introduced by a mutual contact through the Navy Seal Foundation.
Walchle and his wife, Melissa, had made a name for themselves in the U.S. military community for their success with Survival Straps, the couple’s previous venture which has resulted in the sale of over 1 million paracord bracelets— multipurpose bands that can be used to create shelter, traps for food, fire and more if the wearer is stranded in the outdoors— in the past six years. The Walchles began that company about eight years ago.
When Walchle heard about the potential business opportunity with InBalance, he was skeptical. But when he tested the technology himself and began sleeping better, having reduced pain in his elbow and more endurance while running, he was sold, and decided to embed the technology in the same material used to make Survival Straps.
“Our Survival Straps products have been credited with saving lives,” Walchle told FoxNews.com. “Then this technology comes along, and I’m like, ‘Oh my God, is this for real? What an incredible way that we can not just help people when there’s an emergency and they really need it, but we can improve people’s quality of life.’ I thought, ‘What a gift.’”
Putting Active Edge to the test
Active Edge offers PEMFT through its necklace and performance bracelet, each which are sold on its website for about $60, as well as through its fusion belt, which goes for about $65. For now, its products are marketed as performance enhancers, but the company is working with the U.S. Department of Defense (DoD) to conduct separate clinical trials that can provide scientific evidence that the devices also reduce inflammation and offer a direct medical benefit. By testing its products through the DoD, Active Edge is aiming to avoid the time and money often involved in earning FDA approval— a process that could cost millions of dollars and upwards of 10 years, Walchle said.
Over the past four years, Active Edge has run about 25 independent clinical trials involving nearly 2,500 men and women between ages 18 and 82. Tests suggest the product results in a 17 percent average increase in range of motion, a 12 percent average increase in grip strength, an 8 percent average reduction in fatigue with an increase in REM restorative sleep time, and a 23 percent increase in oxygen intake.
Two separate, small clinical trials have been conducted at the University of Florida Shands Hospital in an effort to show the technology has an effect on blood flow and inflammation with thermal imaging evidence.
Robert Erickson, medical director of Gainesville Thermogarphy, in Gainesville, Fla., who supervised the studies at the University of Florida, said both trials revealed the technology changed temperature differentials and resulted in thermal imaging differences in study participants who wore them.
“In some way, this electromagnetic energy is interacting indirectly or directly with the sympathetic nervous system, which is part of the involuntary nervous system,” Erickson told FoxNews.com.
The involuntary nervous system ends at the dermatome, located on the skin’s surface, which can be analyzed with thermography to study inflammation in different parts of the body including the spine, the liver and the kidneys, Erickson said. Thermography looks at temperature changes due to sympathetic nervous system changes.
“Unlike an X-ray that penetrates through the organ, [with thermography], you can get a view of what’s going on inside the body,” Erickson said.
During the first trial, a double-blind study, Erickson and a thermographer had four people wear headbands. Two headbands were treated and two were not.
The thermographer took the participants’ thermal images at baseline three minutes prior to putting on the headbands and again three minutes after wearing them.
After a separate medical company interpreted the findings, results suggested thermal changes and decreases in temperature differentials among people wearing both the untreated and treated headband, but that those changes were most statistically significant among those people wearing the treated version.
In a follow-up study involving an additional seven patients, Erickson analzyed how the technology affected thermal imaging on certain parts of the body when pulsed through other material: T-shirts, socks and wristbands.
He and the thermographer used digital infrared thermal imaging (DITI) scans of people not wearing the treated technology as a baseline to compare imaging before and after wearing the devices.
Participants wore the treated devices anywhere from 20 minutes to overnight, and again— this time through their own analysis— Erickson noted statistically significant differences in thermal imaging and temperature with the various materials.
“We’re ultimately composed of atoms,” Erickson said. “The electromagnetic environment can have a physiological effect on the body.”
None of the participants in either study reported any adverse side effects from the devices, nor did they feel the electromagnetic currents being generated through the material.
The research involving Active Edge’s embedded technology has not been peer-reviewed or published in a scientific journal.
The future of Active Edge
The DoD is currently testing Active Edge technology and the preliminary results are “outstanding,” Walchle said, but, due to a confidentiality agreement, he could not reveal more information.
“We’ve figured out how to shoot radio frequencies at a product that will attach to the cell wall and stay within the product— and that’s a big deal,” Walchle said.
Walchle added that while the FDA has approved the use of PEMF devices that can be used only about 200 times, some Active Edge products have six-year-old technology that still work.
As the DoD continues to test the technology, Active Edge is aiming to have at least a half of a million products on the market within the next year, Walchle said. For now, the company is preparing to release its next product, the Active Edge Sleep Shirt, online Wednesday. The shirts will be sold for $49.
Walchle, who said he’s struggled with restlessness since he can remember, falls asleep quicker and stays asleep more soundly with Active Edge technology.
“I’ll sleep seven to eight hours now, and it is the craziest thing to me,” said Walchle, who added that the company’s independently run clinical trials suggest 80 percent of the people who wear the devices notice improved sleep.
Paul Tesori, of Ponte Vedra, Fla., has spent his entire life playing golf and the past 15 years caddying. Tesori told FoxNews.com that his Active Edge bracelet has reduced joint pain and helped increase the fluidity of his golf swing.
“I made a ‘1’ the other day and said if I break seven today, I’ll become a part owner,” Tesori, 43, joked.
Philip Gordon, 54, of Gainesville, Fla., works at a local country club and enjoys playing basketball in his spare time. He’s been wearing the Active Edge bracelet for about a year.
“When I don’t have it on, it seems like I get tired quicker,” he said. “When I put it on, it seems like I can play longer … and from my energy level, it seems like I get a second wind.”
As for Baker, the former tractor trailer driver, the technology has reduced his tremors so much that he seldom uses his walker anymore. He has also been able to change the oil in his pickup truck and even rebuild the deck in his backyard.
“I’m doing more,” Baker told FoxNews.com. “I’m more energetic now, and I know that I won’t stumble and fall. I’ve got more confidence now.”
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