Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton

Exclusion Criteria32

• Significant osteoporosis that may increase the risk of fracture
• Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years
• Spinal instability (or use of spinal orthoses, unless medically approved)
• Deterioration >3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor.
• Severe spasticity: Level 4 on the Modified Ashworth Scale
• Orthostatic hypotension: Inability to tolerate at least 10 minutes in an upright position
• Uncontrolled autonomic dysreflexia
• Medical instability
• Unstable cardiovascular condition, hemodynamic instability, untreated hypertension (SBP > 140 mmHg, DBP > 90 mmHg), deep vein thrombosis (DVT), or uncontrolled autonomic dysreflexia
• Severe comorbidities, including any condition deemed inappropriate by the investigator for using the ABLE Exoskeleton or for completing the study
• Pressure ulcers Grade I or higher (as defined by the European Pressure Ulcer Advisory Panel - EPUAP) in areas that will be in contact with the device
• Anthropometric measurements incompatible with the ABLE Exoskeleton, specifically height outside the 1.5-1.9 m range or weight exceeding 100 kg
• Anatomical constraints (such as leg length differences, users unable to position themselves inside the device) that are incompatible with the device
• Range of motion restrictions preventing normal gait or sit-to-stand transitions, including: Ankle: ability to achieve at least neutral (0°) position; Knee: ability to extend to at least -10°; Hip: bilateral hip flexion of at least 100° and extension of at least 0°
• Heterotopic ossification
• Pregnant or breastfeeding women
• 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
• Requires assisted ventilation.
• Scoliosis >40-50º Cobb angle.
• Presence of pacemakers, defibrillators, or other non-compatible electronic implants.
• Open wounds, infections, or active irritation at the electrode placement sites.
• Severe dermatological conditions in the stimulation area.
• Uncontrolled active epilepsy.
• Malignant tumors in the area of application.
• Severe loss of sensation in the areas where electrodes are to be placed.
• Medical conditions where electrical stimulation is contraindicated by physician recommendation.
• Inability to communicate pain, discomfort, or adverse reactions during stimulation.
• Venous thrombosis, thrombophlebitis, or severe arterial obstruction.
• Chronic venous insufficiency with significant varicosities.
• Hemophilia.
• Ongoing infectious process or fever.
• Presence of metallic implants in the flow area between the electrodes