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Neurological Rehabilitation

Session: Usability and safety assessment of the Atalante exoskeleton in patients with tetraplegia and high paraplegia

Usability and Safety Assessment of the Atalante Exoskeleton in Patients with Tetraplegia and High Paraplegia

Saturday, October 25, 2025
8:00 AM - 9:30 AM MT
Location: Kiosk 8
Disclosure(s):
Amelie Durand, PT: No relevant disclosure to display
Vincent Pean, PhD: No relevant disclosure to display
Jean PREVINAIRE, MD: No financial relationships to disclose
Background and/or Objectives: To assess the safety and usability of a hands-free Atalante exoskeleton in patients with tetraplegia and high paraplegia.

Design: Retrospective, national and multicentric study.

Setting : Three inpatient rehabilitation centers in France.

Participants : Thirty-three patients, diagnosed with spinal cord injury (SCI; C4 to T4 neurological level of injury [NLI]) and having completed at least one session of exoskeleton training, were included in the study: 12 with motor complete tetraplegia, 10 with motor incomplete tetraplegia, 10 with motor complete paraplegia, and 1 with motor incomplete paraplegia, with an average time since injury of 2.6 ± 4.7 years.

Interventions: Not applicable

Main Outcome Measures: Reported device-related adverse effects (AEs), exoskeleton session data, and clinical outcomes, including functional independence (Spinal Cord Independence Measure [SCIM]), and walking ability (Walking Index for Spinal Cord Injury II [WISCI II]), were collected.

Results: Patients underwent an average of 17.1 ± 20.9 exoskeleton rehabilitation sessions (mean ± standard deviation), with a verticalization duration of 24.3 ± 11.0 minutes and 636 ± 398 steps performed. Only one minor AE was reported, involving hypotension, fatigue and dizziness, leading to the discontinuation of sessions for one patient (NLI T1, complete SCI). 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 additional patient (NLI C5, incomplete SCI) discontinued the sessions due to apprehension. Regarding clinical outcomes, positive changes were observed for SCIM scores (in all patients) and WISCI scores (in those with incomplete SCI), yielding average differences of 5.0 ± 7.5 and 4.8 ± 5.9 points, respectively.

Conclusions: This study indicates that Atalante exoskeleton is safe, feasible, and well-tolerated for gait and balance rehabilitation in patients with high-level SCI.