Investigational Studies Completed: All Paraplegic Patients Walked During First Session
BERKELEY, CA, Feb 15, 2012 (MARKETWIRE via COMTEX) — Ekso Bionics today announced that the first commercial unit of its Ekso exoskeleton was delivered yesterday, on February 14, to Craig Hospital in Denver. Ekso is a wearable robot that powers paraplegics up, enabling them to stand and walk. In addition — working together with top rehabilitation centers in the U.S. — Ekso Bionics just completed a ten-month Investigational Study of Ekso that entailed reciprocal information sharing and learning, training, as well as the definition of clinical protocols. Delivery of Eksos — beginning with Ekso Bionics’ Charter Rehabilitation Centers — will take place over the course of the next three months.
Ekso is a ready-to-wear, battery-powered exoskeleton designed for patients with spinal cord injuries and pathologies that inhibit their ability to walk. It is strapped over the user’s clothing. The patient doesn’t bear the weight, however, as the device transfers its 45 lb. load directly to the ground. Each Ekso can be adjusted in a few minutes to fit most people weighing 220 pounds or less, and between 5’2″ and 6’2″, with at least partial upper body strength, and can be adjusted to fit one patient and then another in minutes.
“We said we’d be shipping the first units in Q1 of 2012, and we made that deadline,” explained Eythor Bender, Ekso Bionics’ CEO. “Ekso Bionics has fulfilled all of the FDA requirements that empower the company to sell the first commercial version of the Ekso exoskeleton to rehabilitation centers,” he added. The sale of each exoskeleton to rehabilitation centers includes “Ekso +,” a comprehensive service, financing and training program.
Investigational studies of the device at the Charter Rehabilitation Centers have just been completed. The ten-month program defined clinical protocols, and provided insights into ways to improve the device. The charter hospitals will also become the first Ekso Centers in the world, conducting ongoing research, and offering the device for the rehabilitation of their patients.
Among the preliminary results of the Investigational Studies:
- 70 subjects were proposed by the rehabilitation centers.
- All 63 patients that passed the preliminary health screening were able to walk81 to 638 steps during their first session in Ekso.
- 7 of the 70 proposed subjects did not pass the preliminary screening due to flexibility, bone density and/or weight issues, so were unable to participate.
- The average number of steps taken in a session was over 200.
- 4,000 to 5,000 steps were taken on average per Investigational Study week.
“It was phenomenal,” architect Robert Woo and patient explained to the NY Daily News after taking 300 steps at Mount Sinai Medical Center in New York City, where he’s undergoing rehabilitation. “I was so excited to be walking on my own two feet, walking naturally.” Michael Rhode, a C6/7 quadriplegic at the Kessler Institute, thought the experience “was one of the most unbelievable feelings I’ve ever had. I just started walking.” He certainly did. Michael took 520 steps during his first session in Ekso.
“We’ve been wowed by the dedication and willingness to collaborate on the part of our rehabilitation partners,” stated Eythor Bender. “The input from their world-class physical therapists led to multiple new and improved features on the Ekso device, such as the adjustment of the harnessing system and the control interface. All of these remarkable centers are still on this journey with us and in it for the long haul. Knowing that every single participant stood and walked during their first session confirms that we are on track to alter the future of spinal cord injury rehabilitation,” he added.
Darrell Musick, PT clinical director for Ekso Bionics, oversaw the Investigational Studies and explained, “We were able to verify the safety of the device with various injury levels, body types and varying height/weight. Moreover, we worked closely with 31 physical therapists and successfully tested the user experience together.”
“Our initial testing clearly showed that with some assistance, patients with different levels of spinal cord injuries (SCI) can walk with Ekso. At Kessler Foundation, we plan to look not just at mobility, but the impact of that mobility on serious health issues. Do walking and standing improve bone and muscle strength, circulation, respiratory function, skin integrity, mood, and even bowel and bladder function? These are the really important issues we want to explore for people in wheelchairs, whether their impairment is caused by spinal cord injury, or stroke, MS, or brain injury,” added Gail F Forrest, Ph.D., senior research scientist, Human Performance & Engineering Research at Kessler Foundation.
Ekso Bionics’ Charter Rehabilitation Centers are:
- Craig Hospital, Englewood, CO
- Good Shepherd Rehabilitation Network, Allentown, PA
- Kessler Foundation, West Orange, NJ
- Mount Sinai Medical Center, NY, NY
- Rehabilitation Institute of Chicago (RIC), Chicago, IL
- RIM Rehabilitation Institute of Michigan, Detroit, MI
- Rehabilitation Hospital of the Pacific, Honolulu, HI
- Santa Clara Valley Medical Center, San Jose, CA
- Shepherd Center, Atlanta, GA
- Spaulding Rehabilitation Hospital, Boston, MA
- TIRR Memorial Hermann, Houston, TX
About Ekso Bionics Ekso Bionics ( http://www.eksobionics.com ) — formerly known as Berkeley Bionics and headquartered in Berkeley, California with offices in London, UK — is a designer and maker of wearable robots, or exoskeletons, that physically augment humans.
SOURCE: Ekso Bionics