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

Inclusion Criteria: * 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 Exclusion Criteria: * Significant osteoporosis that may increase the risk of fracture * Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years * 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 * 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 * Skin integrity problems on the contact surfaces of the device or that would prevent sitting * Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton * 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 diffe…