Publication of an independent, investigator-initiated peer-reviewed study which provides long-term real-world evidence on the safety, utilization and user experience of the ReWalk® Personal Exoskeleton in individuals with chronic paraplegia.
The study titled "Long-term availability of powered exoskeleton for ambulation in domestic context: A cross-sectional study to assess safety, usage pattern, and satisfaction after long-term use," was published in Spinal Cord Series and Cases, an official journal of the International Spinal Cord Society published by Springer Nature. The study evaluated seven individuals with chronic paraplegia who used a ReWalk 6.0 Personal Exoskeleton at home following structured training. Participants used the ReWalk Personal Exoskeleton for a median of 33 months, with individual periods ranging from 20 to 45 months.
ReWalk, FDA- cleared in the U.S. and CE Marked in Europe, is a wearable robotic exoskeleton that enables individuals with spinal cord injury to stand and walk in their homes and communities, including navigating stairs and curbs. The system is covered by Medicare for eligible beneficiaries and is supported by a growing body of clinical and real-world evidence.
The authors of the independent study noted that existing literature has largely focused on shorter-term exoskeleton use in controlled settings and therefore designed this study to examine longer-term use outside the clinic. The study provides evidence that appropriately selected and trained individuals with chronic paraplegia can maintain long-term use of a personal exoskeleton over a period of years in a real-world home environment.
Highlights from the study include:
No reported falls or exoskeleton-related fractures during the median 33-month observation period.
Sustained utilization, with 6 of 7 participants recording more than 3,000 steps per month. Across participants, use ranged from 446 to 12,822 steps per month. One participant with limited caregiver availability had substantially lower utilization, and the authors identified the availability of a qualified caregiver as a key factor affecting continued use.
High user satisfaction, with a median QUEST satisfaction score of 4.2 out of 5, and a median System Usability Scale score of 70 out of 100.
Patient-reported improvements in bowel and bladder management and pain. Participants reported median improvements of 3 points on a 5-point Likert scale for both bowel and bladder management and a median 4-point reduction in pain on the Visual Analogue Scale.
Measurable walking performance after prolonged home use. Participants walked a median 129 meters during the six-minute walk test without stopping to rest and achieved a median walking speed of 0.43 meters per second (i.e., modified community ambulation) during the 10-meter walk test.
All 7 participants reported that walking with ReWalk improved their quality of life and mental health, with median depression and anxiety scores below thresholds for mild symptoms.