Ekso Bionics Holdings, Inc., a robotic exoskeleton company, announced that nine leading centers in Europe including SPZ Notwill in Switzerland, Institut Guttmann in Spain and The Clinic for Spinal Cord Injuries in Hornbaek, Denmark (now part of Rigshospitalet and Glostrup Hospital), are participating in a clinical study to include close to 70 participants.
The study will examine how Ekso GT may improve general outcomes as well as reduce secondary complications, such as pain and bowel and bladder dysfunction, commonly associated with spinal cord injury (SCI), and is expected to run for 30 months with early findings expected next year.
"This landmark study is the first one of its kind," says Thomas Looby, president and chief commercial officer. "While smaller, early trials have shown great promise, the time is right for Ekso Bionics to lead the charge in building a compelling dataset across a range of treatment protocols and clinical environments. This will be an important step to becoming standard of care for SCI rehabilitation and we are proud to be working with these luminaries as they pave the way for widespread exoskeleton use with their patients."
The study-coordinating center is the Clinic for Spinal Cord Injuries in Hornbaek, Denmark at Rigshospitalet and Glostrup Hospital; Principal investigator is Fin Biering-Sorensen, PhD. Head of the Department for Spinal Cord Injuries, Glostrup Hospital, Denmark and Professor in Spinal Cord Injuries at the University of Copenhagen, Professor Biering-Sørensen is past President of the International Spinal Cord Society (ISCoS) and has been a major figure in SCI clinical research for many years. The Pan European study clinical center networks also include:
*Fundación Lesionado Medular (FLM), Barcelona, Spain
*Heliomare revalidatie, Heliomare, The Netherlands
*Institut Guttmann Neurorehabilitation Hospital, Madrid, Spain
*Institutionen för medicin och hälsa (IMH), Linköpings universitet, Sweden
*Spinalenheten, Akademiska sjukhuset Uppsala, Sweden
*Sunnaas Sykehus HF, Oslo, Norway
Swiss Paraplegic Centre (SPZ), Notwill, Switzerland
Universitäts- und Rehabilitationskliniken (RKU), Ulm, Germany
"Patient and physician interest has been very high so far and the initial response to the study design has been positive," said Fin Biering-Sorensen, Principle Investigator. "I'm excited to lead a study of this scope to not only compile evidence for how these exoskeletons fit into the current continuum of care for SCI patients, but also could eventually improve quality of life with home use."
Ekso Bionics designs, develops, and commercializes exoskeletons, or wearable robots, which have a variety of applications in the medical, military, industrial, and consumer markets. Exoskeletons are ready-to-wear, battery-powered robots that are strapped over the user's clothing, enabling individuals to achieve mobility, strength, and endurance not otherwise possible.
Ekso Bionics' lead product, EksoTM, is a wearable bionics suit that enables individuals with any amount of lower extremity weakness to stand up and walk over ground. Ekso Bionics is forging a new frontier in rehabilitation for people living with the consequences of stroke, spinal cord injury, and other neurological conditions affecting gait.