Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia

Measured through all reported adverse device effects (ADEs). ADEs are categorized into the following categories: musculoskeletal, cutaneous (skin abrasion), cardiovascular (orthostatic hypotension), pain, falls, and fractures and are further characterized as minor or serious based on the nature and the severity of the adverse event (AE).

This may involve the use of the Modified Ashworth Scale or a general description of spasticity recorded in the medical file.

This may involve Walking Index for Spinal Cord Injury, version II (WISCI II) assessing the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI. It ranges from 0 (unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters).

This may involve 10 meters walk test (10MWT) measuring gait speed during a 10-meter walk during comfortable and rapid pace.

This may involve Time Up and Go (TUG), a timed task where the patient is asked to stand up from the chair, walk 3 meters, turn around, walk and sit again.

This may involve 6-minutes' walk test (6MWT) and 2-minutes' walk test (2MWT) measuring the walked distance during a 6- or 2-minutes' walk.

This may involve Berg Balance Scale (BBS) including items include static and dynamic activities of varying difficulty.

This may involve Spinal Cord Independence Measure (SCIM III) including items assessing self-care, respiration and sphincter management.

The assessment of the usability will be asked to the operators in charge of the rehabilitation of the patients included in this study. It includes a usability questionnaire and session data collection.

To characterize the population, for each patient, the age will be collected when available (years).

To characterize the population, for each patient, the gender will be collected when available (male, female).

To characterize the population, for each patient, the cause of injury or pathology, the time since injury or diagnosis (years) will be collected when available.

To characterize the population, for each patient, the urinary status will be collected when available:

• Intermittent catherization
• Indwelling catherization
• External collection device
• Other

To characterize the population, for each patient, the bowel status will be collected when available:

• Digital stimulation
• Manual evacuation
• Colostomy
• Other

To characterize the population, for each patient, the following descriptive data will be collected when available:

• ASIA impairement scale: A (complete), B (sensory incomplete), C and D (motor incomplete), E (normal).
• Neurological Level of Injury

To characterize the population, for each patient, cardiorespiratory parameters including Heart Rate (HR) in Beats per minute and Blood Pressure (BP) in mmHg will be collected when available.

To characterize the population, for each patient, intensity of the pain using the subjective Numeric Pain Rating Scale (NPRS) will be collected when available: from 0 (no pain) to 10 (worst possible pain).

To characterize the study population, bone health data will be collected for each patient, when available, including:

• T-score values ranging from 0 (normal) to below -2.5 (indicative of osteoporosis)
• Bone Mineral Density (BMD) measurements expressed in g/cm²

The reason(s) for discontinuing sessions may include hospital discharge, patient's decision, pain or discomfort, achievement of goals set by the therapeutic team, etc.