Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.

Exclusion Criteria

• •Any medical contraindication for standing or walking.
• •Presence of non-reducible contractures or heterotopic ossification above the degrees allowed by the device and/or outside the trajectory imposed by the device.
• •Spasticity (MAS) = 4 in lower limbs at the time of device use.
• •Structured hip and/or knee contracture greater than 20 degrees.
• •Inability to stand or walk with more than 5 degrees of hip abduction.
• •Inability to achieve 5 degrees of dorsal ankle flexion from the neutral position with or without orthosis.
• •Tibial leg length discrepancy that cannot be mitigated with the use of a foot wedge.
• •Skin alterations in areas of contact with the device.
• •History of fracture without trauma.
• •Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe pulmonary disease).
• •Behavioral disorders that interfere with proper use of the device, such as impulsivity.
• •Allergy to any of the materials of the EXPLORER CLÍNICO: cotton, nylon, polyester, PPS, PEEK, or ABS. The materials used in EXPLORER CLÍNICO that were not previously used in ATLAS 2030, a medical device certified by the AEMPS, are PPS, PEEK, and ABS.