Abstract
Study design
Prospective quasi-experimental study, pre- and post-design.
Objectives
Assess safety, feasibility, training characteristics and changes in gait function for persons with spinal cord injury (SCI) using the robotic exoskeletons from Ekso Bionics.
Setting
Nine European rehabilitation centres.
Methods
Robotic exoskeleton gait training, three times weekly over 8 weeks. Time upright, time walking and steps in the device (training characteristics) were recorded longitudinally. Gait and neurological function were measured by 10 Metre Walk Test (10 MWT), Timed Up and Go (TUG), Berg Balance Scale (BBS), Walking Index for Spinal Cord Injury (WISCI) II and Lower Extremity Motor Score (LEMS).
Results
Fifty-two participants completed the training protocol. Median age: 35.8 years (IQR 27.5–52.5), men/women: N = 36/16, neurological level of injury: C1-L2 and severity: AIS A–D (American Spinal Injury Association Impairment Scale). Time since injury (TSI) < 1 year, N = 25; > 1 year, N = 27.
No serious adverse events occurred. Three participants dropped out following ankle swelling (overuse injury). Four participants sustained a Category II pressure ulcer at contact points with the device but completed the study and skin normalized. Training characteristics increased significantly for all subgroups. The number of participants with TSI < 1 year and gait function increased from 20 to 56% (P = 0.004) and 10MWT, TUG, BBS and LEMS results improved (P < 0.05). The number of participants with TSI > 1 year and gait function, increased from 41 to 44% and TUG and BBS results improved (P < 0.05).
Conclusions
Exoskeleton training was generally safe and feasible in a heterogeneous sample of persons with SCI. Results indicate potential benefits on gait function and balance.
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Acknowledgements
We thank Linda Jones, PT, MS, Consultant, for writing the initial protocol. We would also like to thank all participants with SCI for being part of the study and to express our gratitude to the following therapists who took part in the training protocol and data collection:Mette Skov Henriksen and Mats Christer Nilfyr (Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Hornbaek, Denmark); Michael Baumberger and Ines Bersch-Porada (Swiss Paraplegic Centre (SPC), Nottwil, Switzerland); Sebastian Stallasch and Sebastian Lux (Universitäts- und Rehabilitationskliniken (RKU), Ulm, Germany); Esperanza Moreno and German Novillo (Fundación Lesionado Medular (FLM), Madrid, Spain); Niklas Fransson, Anna-Karin Hansson, Anna Granström and Mikael Lundgren (Clinical Department of Rehabilitation Medicine at Linköping University Hospital, Jönköping hospital and Västervik hospital, Sweden); Margareta Arnell and Peter Svensson (Spinal Cord Rehabilitation Unit, Uppsala University Hospital, Sweden); Ole Christian Andersen, Anna-Beth Netteland, Trygve Danielsen, Gyri S. Ingebretsen (Sunnaas Sykehus HF, Oslo, Norway); Eloy Opisso, Raquel Lopez, Josep Medina, Manel Ochoa and Eva Morales (Institut Guttmann, Neurorehabilitation Hospital, Barcelona, Spain); David Gobets, Mark van de Mijll Dekker, Ruth Sijsma (Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands). All authors were supported by their institutions’ internal funds. Ekso Bionics™ provided an unconditional grant for protocol writing, salary for the clinical study lead, and expenses related to the shared database to compile data across the nine centres.
Funding
Each centre was funded independently by grants or internal funds required for data collection on site. Department of Rehabilitation Medicine and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden were funded by Stiftelsen Promobilia, Region Östergötland and Medical Research Council of Southeast Sweden. Spinal Cord Rehabilitation Unit, Uppsala University Hospital, Sweden was funded by Uppsala University Hospital ALF funds. Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway was funded by Sunnaas Stiftelsen (The Sunnaas Foundation). Remaining centres were funded by internal funds. Ekso Bionics provided an unconditional grant for protocol writing, salary for the clinical study lead, and expenses related to the shared database to compile data across the nine centres.
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Carsten Bach Baunsgaard and Ulla Vig Nissen contributed equally to this work.
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Bach Baunsgaard, C., Vig Nissen, U., Katrin Brust, A. et al. Gait training after spinal cord injury: safety, feasibility and gait function following 8 weeks of training with the exoskeletons from Ekso Bionics. Spinal Cord 56, 106–116 (2018). https://doi.org/10.1038/s41393-017-0013-7
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DOI: https://doi.org/10.1038/s41393-017-0013-7
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