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).