临床证据

临床研究:正在进行和完成

自2012年以来,Ekso Bionics,Inc。一直使用Ekso设备赞助或支持临床研究。绝大多数已完成和正在进行的研究都是由研究者发起的。截至2019年6月,已完成65项研究和40项正在进行的研究。这105项研究涉及1800多名参与者。大约一半的研究是在美国境内进行的,其余部分在欧洲,中东和非洲地区。因为第一个Ekso装置是为脊髓损伤(SCI)设计的,所以大多数早期研究是在SCI参与者的基础上进行的。随着更新的硬件和软件适应更多的损伤,中风和其他神经系统诊断患者的研究正在迅速增加。正如预期的那样,许多可行性研究已经导致更大的研究(单臂或比较),其中时间和资源的投入相当大。 Ekso Bionics,Inc。仍致力于通过研究展示临床效益。下图显示了当前EksoGT研究的领域现在如何更加多样化。

出版物和演示文稿

过去使用Ekso设备的研究活动最终在70个会议演示文稿,章节和发表的文章中达到高潮,其中包括15篇评论文章。 在已发表的文章中,37篇描述了Ekso在脊髓损伤患者中使用的结果,8篇报道了与中风幸存者中Ekso相关的研究,2篇涉及全身性虚弱,瘫痪或步态障碍,1篇涉及多发性硬化症。 除步态功能外,2019年的出版物主要关注住院康复,心脏代谢效应以及用户对EksoGT培训的满意度。

参考

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 EksoGTTM 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.