Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study.

Context/objective: Information on the safety and feasibility of lower extremity powered exoskeletons for persons with acute/sub-acute spinal cord injury (SCI) is limited. Understanding the safety and feasibility of employing powered exoskeletons in acute/sub-acute (<6 months post injury) at a SCI acute inpatient rehabilitation (SCI-AIR) facility could guide clinical practice and provide a basis for larger clinical trials on efficacy and effectiveness. Design: Single group observational study. Setting: SCI-AIR. Participants: Participants (n = 12; age: 28-71 years; 58% AIS D; 58% male) with neurological levels of injuries ranging from C2 to L3. Interventions: Up to 90 min of exoskeleton-assisted locomotor training was provided up to three times per week during SCI-AIR. Outcome measures: Safety of device use during inpatient locomotor training was quantified as the number of adverse events (AE) per device exposure hour. Feasibility of device use was defined in terms of protocol compliance, intensity, and proficiency. Results: Concerning safety, symptomatic hypotension was the most common AE reported at 111-events/exoskeleton-hours. Protocol compliance had a mean (SD) of 54% (30%). For intensity, 77% of participants incorporated variable assistance into at least 1 walking session; 70% of participants' sessions were completed with a higher RPE than the physical therapist. In proficiency, 58% achieved at least minimal assistance when walking with the device. Conclusion: Exoskeleton training in SCI-AIR can be safe and feasible for newly injured individuals with SCI who have clinically defined ambulatory goals. Nonetheless, sufficient controls to minimize risks for AEs, such as hypotensive events, are required.