Published evidence regarding Atalante X and Eve, and the supporting documents
Clinical evidence
Rehabilitation using Atalante X may support patients' physical improvement—including endurance, walking ability, balance, and trunk postural control.1
Atalante X is safe for use in diverse populations and patients living with stroke and spinal cord injury.1
Patients who used Atalante X report extremely high satisfaction rates, up to 100%.1
Key Takeaways, Benefits of Atalante X One-Pager, December 2024
After a stroke
After 5 sessions of Atalante training, patients showed an improvement in gait speed of 0.05 ± 0.08 m/s (p=0.002), their endurance by 11.6 ± 18 meters (p=0.001), their ambulatory capacity (FAC score) by 0.6 ± 1.0 points (p=0.002), and their balance (BBS score) by 6.2 ± 8.1 points (p=0.0001).1
87% of patients were satisfied with the program and would recommend it to other stroke patients.1 The peer-reviewed INSPIRE safety study provides a full account of the same program.2
INSPIRE — 31 patients, 6 centers. Results measured without the device.
What Patients Report
The satisfaction rate at the end of the program was 86%.1
Patients with paraplegia also reported improved sitting balance, psychological well-being, and endurance.4
Post-Market Clinical Follow-up Report — 18 patients, 16 centers
Tetraplegia and high paraplegia
We can conclude that the use of the Atalante X exoskeleton is safe and feasible for this population.5
One adverse event occurred during 547 Atalante sessions.6 The peer-reviewed retrospective study adds: following an individual benefit-risk assessment, the Atalante exoskeleton can be safely used in a clinical setting for patients with high-level spinal cord injuries.7
QUATRO — 33 patients with spinal cord injury, 3 centers
In the intensive care unit
Physiotherapy using Atalante in the acute neurosurgery setting is safe and feasible. Staff organization is a key factor in success.18
The average time to stand was 16 minutes, and 100% of patients were satisfied and expressed a desire to repeat exoskeleton sessions.1 ICU-acquired weakness is equivalent to a 40% loss of muscle strength after one week of immobility.9
17 patients, 1 center. The newest area of application, and the smallest body of evidence to date.
Outside a trial
Registry and program data from centers running Atalante X as part of their regular clinical practice, rather than under study conditions.
patients at 34 rehabilitation centers in Europe and the United States, February 2021 through November202310
number of steps walked in one year by more than 60 patients at a single rehabilitationinstitute11
of weekly sessions in ALERT, with both sitting balance and walking distanceshowing improvement12
An exoskeleton is not intended to replace the work of a physical therapist; it is a tool that can be used to improve patient outcomes through a high-tech, innovative collaboration between physical therapists and patients.
13
Franco Molteni, Villa Beretta Rehabilitation Research and Innovation Institute
Real human expertise, every step of the way.
Gait training exoskeletons, such as the Atalante X, are innovative tools for managing people with walking impairments. They maximize rehabilitation training in the hope of improving recovery following a neurological injury and preventing complications resulting from prolonged immobilization.
