Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting

Other illness

• Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years
• Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP\>140, DBP\>90 mmHg), unresolved deep venous thrombosis (DVT), uncontrolled autonomic dysreflexia
• Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study
• Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton
• Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures

Other

• Significant osteoporosis that may increase the risk of fracture
• Spinal instability (or spinal orthoses, unless authorized by a physician)
• Severe spasticity: Level 4 on the Modified Ashworth Scale
• Orthostatic hypotension. Inability to tolerate a minimum of 10 minutes standing
• Uncontrolled autonomic dysreflexia
• Medical instability
• Skin integrity problems on the contact surfaces of the device or that would prevent sitting
• Colostomy
• Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg
• Anatomical constraints (such as leg length differences, users unable to position themselves inside the device) that are incompatible with the device
• Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting
• Heterotopic ossification
• Known pregnancy or breastfeeding
• Requires assisted ventilation.
• Scoliosis \>40-50º Cobb angle.

• 18 to 80 years old
• Diagnosed with acquired brain injury (ABI)
• Currently undergoing outpatient physical therapy treatment in one of the investigation sites
• Ability to give informed consent