ArticleSpinal cord series and cases2026
Retrospective safety evaluation of the atalante exoskeleton in a clinical setting in patients with tetraplegia and high paraplegia.
Article in Spinal cord series and cases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
STUDY
designRetrospective study.
objectivesTo evaluate the safety of the Atalante exoskeleton in patients with tetraplegia and high paraplegia.
settingThree inpatient rehabilitation centers in France.
methodsData from thirty-three inpatients with tetraplegia (12 motor complete (American Spinal Injury Association Impairment Scale (AIS) grade A or B), 10 motor incomplete (AIS C or D)) and high paraplegia (at or above T4 level; 10 motor complete and 1 motor incomplete) and an average time since Spinal Cord Injury (SCI) of 2.6 years (19 individuals < 12 months after injury), who completed at least one session of training with the Atalante exoskeleton, were analyzed. The primary outcome was the safety assessment through reported device-related adverse effects (AE). Secondary outcomes included pain (Numeric Pain Rating Scale), spasticity (Ashworth scale), walking ability (WISCI-II), and exoskeleton session data.
resultsParticipants underwent a median of 7.5 (IQR: 3-22.8) exoskeleton training sessions, with a median verticalization duration of 22.4 min (IQR: 18-26.9) and 583.0 steps (IQR: 347.0-854.0) performed. The estimated rate of AEs per session across all sessions was 0.63%, with a 95% confidence interval ranging from -0.56 to 1.81%. One minor AE occurred in one patient, involving hypotension, fatigue and dizziness, leading to session discontinuation. No therapy-related pain or fracture was reported. Regarding secondary outcomes, spasticity remained unchanged while positive changes were observed in WISCI-II scores in 11 patients with incomplete SCI.
conclusionsAfter individual benefit-risk assessment, the Atalante exoskeleton can be safely used in a clinical setting for high SCI patients. SPONSORSHIP: Wandercraft.
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