A multidimensional evaluation of the Atalante exoskeleton as an assistive locomotion device for individuals with complete paraplegia: a prospective longitudinal study in a controlled environment

BACKGROUND: Robotic exoskeletons are increasingly used in neurorehabilitation, yet evidence remains limited regarding their role as assistive locomotion devices within a compensatory rehabilitation framework, particularly in individuals with complete spinal cord injury. Multidimensional evaluations integrating safety, usability, and patient-reported experience are still scarce. OBJECTIVE: To evaluate the Atalante self-balancing exoskeleton as an assistive locomotion device in individuals with complete paraplegia through a multidimensional analysis conducted in a controlled clinical environment. METHODS: This prospective, monocentric, longitudinal study included adults with chronic complete thoracic spinal cord injury (American Spinal Injury Association Impairment Scale grade A, neurological level T6-T12). Participants underwent an intensive 6-week program comprising 60 supervised sessions of exoskeleton-assisted training including 40 m walking per session. Outcomes were assessed across three complementary dimensions: (1) safety (medical adverse events, safety-related technical incidents, near-falls); (2) techno-functional usability (donning/doffing performance, assistance levels, cumulative walking exposure); and (3) acceptability (patient-reported comfort and perceived safety using session-based visual analogue scales). Physiological responses were evaluated using exoskeleton-assisted 6-minute walk tests. RESULTS: Thirteen participants were enrolled; eleven completed the full protocol. One serious adverse event occurred, a tibial plateau fracture in a participant with severe osteoporosis (hip T-score - 3.8), leading to study withdrawal. No other serious medical adverse events were observed. Across 651 sessions, four near-fall events were recorded (0.61% of sessions and 0.16% per 10 m walked). Minor adverse events were transient, and no symptomatic orthostatic hypotension was reported. Oxygen consumption, walking speed, and cost of transport (p > 0.05) remained stable between mid- and end-program assessments, while perceived exertion decreased significantly (p = 0.003). Donning time decreased from 790 [475-966] s during the first session to 223 [159-259] s during the final sessions, and doffing time from 242 [152-275] s to 55 [50-69] s, with familiarization plateau points observed after 14 and 18 sessions, respectively. Harness comfort improved over time, whereas perceived safety remained globally stable, except for transient decreases following fall-prone gait events or technical disengagements. CONCLUSIONS: Under supervised clinical conditions, the Atalante exoskeleton demonstrated acceptable safety and feasibility as an assistive locomotion device for individuals with complete paraplegia, enabling hands-free upright indoor walking with low metabolic demand. Severe osteoporosis emerged as a critical risk factor, supporting systematic bone densitometry and cautious exclusion criteria. These findings support the integration of self-balancing exoskeletons into compensatory rehabilitation programs and justify further studies in ecological settings to assess real-world autonomy and participation outcomes. Trial registration ClinicalTrials.gov Identifier: NCT06941896 (retrospective registration).