Document Type

Journal Article

Publication Title

Spinal Cord

PubMed ID

35094007

Publisher

Nature

School

School of Medical and Health Sciences / Exercise Medicine Research Institute

Funders

Ekso Bionics Ltd

Comments

Edwards, D. J., Forrest, G., Cortes, M., Weightman, M. M., Sadowsky, C., Chang, S. H., . . . Jayaraman, A. (2022). Walking improvement in chronic incomplete spinal cord injury with exoskeleton robotic training (WISE): A randomized controlled trial. Spinal Cord. Advance online publication. https://doi.org/10.1038/s41393-022-00751-8

Abstract

Study design: Clinical trial. Objective: To demonstrate that a 12-week exoskeleton-based robotic gait training regimen can lead to a clinically meaningful improvement in independent gait speed, in community-dwelling participants with chronic incomplete spinal cord injury (iSCI). Setting: Outpatient rehabilitation or research institute. Methods: Multi-site (United States), randomized, controlled trial, comparing exoskeleton gait training (12 weeks, 36 sessions) with standard gait training or no gait training (2:2:1 randomization) in chronic iSCI ( > 1 year post injury, AIS-C, and D), with residual stepping ability. The primary outcome measure was change in robot-independent gait speed (10-meter walk test, 10MWT) post 12-week intervention. Secondary outcomes included: Timed-Up-and-Go (TUG), 6-min walk test (6MWT), Walking Index for Spinal Cord Injury (WISCI-II) (assistance and devices), and treating therapist NASA-Task Load Index. Results: Twenty-five participants completed the assessments and training as assigned (9 Ekso, 10 Active Control, 6 Passive Control). Mean change in gait speed at the primary endpoint was not statistically significant. The proportion of participants with improvement in clinical ambulation category from home to community speed post-intervention was greatest in the Ekso group ( > 1/2 Ekso, 1/3 Active Control, 0 Passive Control, p < 0.05). Improvements in secondary outcome measures were not significant. Conclusions: Twelve weeks of exoskeleton robotic training in chronic SCI participants with independent stepping ability at baseline can improve clinical ambulatory status. Improvements in raw gait speed were not statistically significant at the group level, which may guide future trials for participant inclusion criteria. While generally safe and tolerable, larger gains in ambulation might be associated with higher risk for non-serious adverse events.

DOI

10.1038/s41393-022-00751-8

Creative Commons License

Creative Commons Attribution 4.0 License
This work is licensed under a Creative Commons Attribution 4.0 License.

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