Clinical Evidence

Clinical Studies: Ongoing and Completed

Since 2012, Ekso Bionics, Inc. has sponsored or supported clinical research using Ekso devices. The vast majority of completed and ongoing studies are investigator-initiated. As of June 2019, there were 65 completed studies and 40 ongoing studies. These 105 studies involve more than 1,800 participants. Roughly half of the research is conducted within the U.S with the remainder within the EMEA. Because the first Ekso device was designed for those with spinal cord injury (SCI), most early research was conducted with SCI participants. With newer hardware and software accommodating more impairments, studies in patients with stroke and other neurological diagnoses have been quickly increasing. As expected, many of the feasibility studies have led to larger studies (single-arm or comparative) where the investment of time and resources is considerable. Ekso Bionics, Inc. remains committed to demonstrating clinical benefit through research. The graph below shows how the areas of the current Ekso research are now more diversified.

Publications and Presentations

Past research activity using Ekso devices has culminated in 70 conference presentations, chapters, and published articles including 15 review articles. Of the published articles, 37 describe results of Ekso use in individuals with spinal cord injury, eight report on research related to Ekso in stroke survivors, two pertain to generalized weakness, paralysis or gait disorders, and one pertains to multiple sclerosis. In addition to gait function, 2019 publications have focused on inpatient rehabilitation, cardio-metabolic effects, and user satisfaction with EksoGT training.

References

Motor Incomplete SCI

  1. Baunsgaard CB, Nissen UV, Brus AK, Frotzler A, Ribeill C, Kalke Y-B, León N, Gómez B, Samuelsson K, Antepohl W, Holmström U, Marklund N, Glott T, Opheim A, Benito J, Murillo N, Nachtegaal J, Faber W, Biering-Sørensen F. Gait training after Spinal Cord Injury: safety, feasibility and gait function following eight weeks of training with the exoskeletons from Ekso Bionics. Ahead of publication.
  2. Bonatti E, Baroncini I, Nalon C, Giovannini T,  Falcone R, Mazolli N, Bonavita J. Locomotor training with exoskeleton EksoGT in patients with incomplete motor spinal cord injury in a hospital setting- preliminary results. Poster presentation. ISCoS Meeting; September 16, 2016.
  3. Flaherty V, Anderson C, Ball K, Furman K, Brady S. Use of the EksoGT Bionics exoskeleton robotic assisted mobility device with acute rehabilitation patients:  preliminary results. Poster Presentation. AMRPA Meeting; October, 2017.
  4. Kern M, Chang S-H, Jennings J, Davis M, Francisco G, TIRR SCI Clinical Exoskeleton Group. Improving gait performance after SCI: a comparison between conventional PT and therapy using exoskeletons. Poster presentation. ASIA Conference, 2015.
  5. Kolakowsky-Hayner SA, Crew J, Moran S, Shah A. Safety and feasibility of using the EksoGT bionic exoskeleton to aid ambulation after spinal cord injury. J Spine. 2013;S4:3.
  6. Kozlowski AJ, Bryce TN, Dijkers MP. Time and effort required by persons with spinal cord injury to learn to use a powered exoskeleton for assisted walking. Topics in Spinal Cord Injury Rehabil. 2015;21(2):110–21.
  7. Milia P, De Salvo F, Caserio M, Cope T, Weber P, Santella C, Fiorini S, Baldoni G, Bruschi R, Bigazzi B, Cencetti S, Da Campo M, Bigazzi P, Bigazzi M. Neurorehabilitation in paraplegic patients with an active powered exoskeleton (Ekso). Digit Med. 2016;2:163-8.
  8. Stampacchia G, Rustici A, Bigazzi S, Gerini A, Tombini T, Mazzoleni S. Walking with a powered robotic exoskeleton:  subjective experience, spasticity and pain in spinal cord injured persons. Neurorehabil. 2016;39(2):277–83.
  9. Umlauf S, Roth T, Schuurmans P, Müller F. Experiences with the exoskeleton EKSOGT BIONICS. Presented at DMGP Meeting; 2014.

Stroke

  1. Flaherty V, Anderson C, Ball K, Furman K, Brady S. Use of the EksoGT Bionics exoskeleton robotic assisted mobility device with acute rehabilitation patients:  preliminary results. Poster Presentation. AMRPA Meeting; October, 2017.
  2. Molteni F, Gasperini G, Gaffuri M, Colombo M, Giovanzana C, Lorenson C, Farina N, Cannaviello G, Scarano S, Proserpio D, Liberali D, Guanziroli E. Wearable robotic exoskeleton for over-ground gait training in sub-acute and chronic hemiparetic stroke patients: preliminary results. Eur J Phys Rehabil Med. 2017;Jan 24. E-pub ahead of publication.
  3. Nolan K. ACRM Presentation. 2016.