The objective of this study is to investigate the long-term effects of rehabilitation using the Atalante X exoskeleton in 100 participants exhibiting lower limb weakness and/or impairments, regardless of the underlying etiology. With the increasing adoption of new technologies in rehabilitation, which promise to enhance clinical practices, it is crucial to understand their impact on relevant clinical outcomes.
During the one-year intervention period, participants will complete at least one exoskeleton session per week (≥36 sessions) with the Atalante X exoskeleton. The additional voluntary year follows the same design. Clinical assessments of gait and balance are conducted prior to the first session and then after 4 and 12 months of rehabilitation, and for those who wish to extend their participation for an additional year, assessments are performed after 16 and 24 months of exoskeleton rehabilitation. The primary objective is to explore the impact of rehabilitation on seated postural control using the Function-in-Sitting Test (FIST). Secondary outcomes include the analysis of rehabilitation sessions (verticalization duration, number of steps, device average assistance) and the incidence of adverse events (AEs).
Fourteen participants (47.8 ± 13 years old) with various impairments, including paraparesis (n=5), complete paraplegia (n=4), tetraparesis (n=4), and hemiparesis (n=1) were included. The duration of their conditions averaged 11 ± 8.3 year. Seven participants have completed 16 months of exoskeleton rehabilitation so far. The average number of performed exoskeleton sessions was of 41.7 ± 6.9 per patient, with a verticalization duration of 39.3 ± 9.6 minutes, 834 ± 282 steps taken, and an average device assistance of 19 ± 24 %. The results indicate significant improvements in seated postural control (FIST: Δ7.1 ± 3.5; Wilcoxon: p0.05). Eighteen adverse events (AEs) were reported, two of which were device-related (elbow pinching), and resolved without consequences.
Preliminary results suggest that rehabilitation with the Atalante X can be performed safely and demonstrates promising improvements in seated postural control among adults with weakness and/or impairments in the lower limbs.
Robotic devices, used in conjunction with conventional methods, could contribute to diversifying practices and optimizing care, while preserving the individualized aspect of rehabilitation.
Gait
Balance
