临床证据

EksoGT的临床证据

临床研究:正在进行和完成

自2012年以来,Ekso Bionics,Inc。使用Ekso 1.1和EksoGT外骨骼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2018年中期,已有近2000名参与者参与了50多项已完成的研究和30项正在进行的研究。 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。 一半的研究是在美国境内进行的,其余部分在欧洲,中东和非洲内部进行。 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。

出版物和演示文稿

过去使用Ekso设备的研究活动在40多个会议演示文稿和出版物中达到顶峰,并在五篇评论文章中进行了介绍。 在已发表的文章中,18篇描述了Ekso在脊髓损伤患者中使用的结果,两篇报道了与中风幸存者中Ekso相关的研究,一篇涉及多发性硬化症。 下图显示了研究领域现在如何更加多样化。

 

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.