Evaluation of safety and performance of the self balancing walking system Atalante in patients with complete motor spinal cord injury
Abstract
Study Design: Prospective, open label, observational. Objectives: To present results of the first clinical study on a newly developed robotic exoskeleton (Atalante®, Wandercraft, Paris, France) that enables individuals with spinal cord injury (SCI) to perform ambulatory functions without technical aids. Setting: Two sites specialized in SCI rehabilitation, France. Methods: Inclusion criteria were presence of chronic complete SCI (AIS A) ranging from T5 to T12. The study protocol included 12 one-hour training sessions during 3 weeks. Patients walked on floor with robotic assistance and wore a harness connected to a mobile suspension system (without weight-bearing) to prevent from falling. Main outcome was the ability to walk 10 meters unassisted, secondary outcomes were assessment of other ambulatory functions, bladder and bowel functions, pain and spasticity. Results: Twelve patients were enrolled, and 11 completed the protocol, mean age 33,9 years. Six patients had T6 levels of lesion or above. Seven patients passed the 10mWT at the 12th session unassisted (mean walking speed 0.13 m/s) while four required some human help. All patients succeeded at the other ambulatory tests (stand-up, sit-down, balance, turn). There were no significant change for bladder (Qualiveen) or bowel (NBD) functions, neuropathic pain (NPSI, NPRS), yet five patients reported a subjective improvement of their bowel function. Impact on spasticity was variable depending on the muscle examined (Ashworth). Ischial skin erosion was seen in one patient that needed local dressing. Conclusion: The Atalante system is safe and enables to perform ambulatory functions in patients with complete SCI.
Additional Information
© The Author(s), under exclusive licence to International Spinal Cord Society 2021. Received 05 November 2020; Revised 16 July 2021; Accepted 16 July 2021; Published 04 August 2021. We would like to thank Amélie Durand, Caroline Soufflet, Pauline Beaumel, and all the Wandercraft team for their role in designing the Atalante exoskeleton and making the presented clinical trial possible. We would also like to thank Thomas Gurriet, Jessy Grizzle, Ayush Agrawal, Koushil Sreenath, Ayonga Hereid at the California Institute of Technology, University of Michigan, Ann Arbor, University of California Berkeley, and the Ohio State University who were instrumental in earlier studies and in the synthesis of dynamic walking algorithms and controllers. This work has been supported by Wandercraft. The Atalante devices used were provided by the study sponsor. Data availability: The datasets analysed during the current study are available from the corresponding author on reasonable request. The authors declare no competing interests.Additional details
- Alternative title
- Evaluation of safety and performance of the self balancing walking system Atalante in 5 patients with complete motor spinal cord
- Eprint ID
- 109821
- Resolver ID
- CaltechAUTHORS:20210714-191344383
- Wandercraft
- Created
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2021-08-04Created from EPrint's datestamp field
- Updated
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2021-08-04Created from EPrint's last_modified field