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

Prior treatment

• 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.

Other illness

• 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.

Other

• 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.

• Age between 2 and 17 years.
• Consent from the participant or legal guardian to participate in the study.
• No diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria for Phase 1
• Age between 2 and 17 years.
• Consent from the participant or legal guardian to participate in the study.
• Diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria Related to the EXPLORER CLINICAL Device Characteristics
• Medical authorization to stand upright and perform weight-bearing gait training.
• Weight less than or equal to 60 kg.
• Hip width less than or equal to 40 cm.
• Distance from the hip joint center to the knee joint center: 21 cm - 36 cm.
• Distance from the knee joint center to the ankle joint center: 20 - 35 cm.
• EU shoe size less than or equal to 40.