Abstract
BACKGROUND: Spinal cord injury (SCI) is a serious clinical condition that impacts a patient's physical, psychological, and socio-economic status. The aim of this pilot study was to evaluate the effects of training with a newly developed powered wearable exoskeleton (Hyundai Medical Exoskeleton [H-MEX]) on functional mobility, physiological health, and quality of life in non-ambulatory SCI patients. METHODS: Participants received 60 minutes of walking training with a powered exoskeleton 3 times per week for 10 weeks (total 30 sessions). The 6-minute walking test (6MWT) and timed-up-and-go test (TUGT) were performed to assess ambulatory function. The physiological outcomes of interest after exoskeleton-assisted walking training were spasticity, pulmonary function, bone mineral density, colon transit time, and serum inflammatory markers. Effects of walking training on subjective outcomes were estimated by the Korean version of the Falls Efficacy Scale-International and the 36-Item Short-Form Health Survey version 2. RESULTS: Ten participants finished 30 sessions of training and could ambulate independently. No severe adverse events were reported during the study. After training, the mean distance walked in the 6MWT (49.13 m) was significantly enhanced compared with baseline (20.65 m). The results of the TUGT also indicated a statistically significant improvement in the times required to stand up, walk 3 m and sit down. Although not statistically significant, clinically meaningful changes in some secondary physiological outcomes and/or quality of life were reported in some participants. CONCLUSION: In conclusion, this study demonstrated that the newly developed wearable exoskeleton, H-MEX is safe and feasible for non-ambulatory SCI patients, and may have potential to improve quality of life of patients by assisting bipedal ambulation. These results suggest that the H-MEX can be considered a beneficial device for chronic non-ambulatory SCI patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04055610.