Safety and tolerance of the ReWalk^™exoskeleton suit for ambulation by people with complete spinal cord injury: A pilot study

Abstract

Objectives: The objective of the study was to evaluate the safety and tolerance of use of the ReWalk ™ exoskeleton ambulation system in people with spinal cord injury. Measures of functional ambulation were also assessed and correlated to neurological spinal cord level, age, and duration since injury. Study design: Case series observational study. Setting: A national spinal cord injury centre. Methods: Six volunteer participants were recruited from the follow-up outpatient clinic. Safety was assessed with regard to falls, status of the skin, status of the spine and joints, blood pressure, pulse, and electrocardiography (ECG). Pain and fatigue were graded by the participants using a visual analogue scale pre-and post-training. Participants completed a 10-statement questionnaire regarding safety, comfort, and secondary medical effects. After being able to walk 100 m, timed up and go, distance walked in 6 minutes and 10-m timed walk were measured. Results: There were no adverse safety events. Use of the system was generally well tolerated, with no increase in pain and a moderate level of fatigue after use. Individuals with lower level of spinal cord injury performed walking more efficiently. Conclusion: Volunteer participants were able to ambulate with the ReWalk ™ for a distance of 100 m, with no adverse effects during the course of an average of 13-14 training sessions. The participants were generally positive regarding the use of the system.

Effects of training with the ReWalk exoskeleton on quality of life in incomplete spinal cord injury: a single case study

“…The study of Zeilig et al, 17 with the help of a satisfaction questionnaire, subjectively pointed to a positive influence on the quality of life, too, which supports the result of this study.…”

“…1,17 This is only one result in accordance to other results which helps to reduce the risk factors of SCI patients.…”

“…1,17 The intervention was free of complications in the study phase. There were no falls, no skin injury or technical problems.…”

Role of Gait Training in Recovery of Standing and Walking in Subjects with Spinal Cord Injury

“…In the evaluation of Rewalk exoskeleton on safety and tolerance in SCI patients, Zeilig et al reported that mean time to walk 10 m was 47 seconds following training when using the Rewalk [45]. In another study, distance walked for 50-100 m announced between 5 and 10 minutes continually.…”

The influence of orthosis options on walking parameters in spinal cord-injured patients: a literature review

“…Nine studies analyzed gait parameters in SCI patients as powered orthoses and exoskeleton. [41][42][43][44][45][46][47][48][49] These studies had a low level of evidence according to the PEDro score (2/10). Powered lower limb orthoses such as the HAL-5 Type-C (hybrid assistive limb), which has five electric motors 45,50 the ReWalk powered orthosis (Argo Medical Technologies), 42,43 the wearable power assist locomotor (WPAL) 41 and the e LEGS powered orthosis (Berkeley Bionics) are all examples of commercially developed powered orthoses designed for walking by individuals with paraplegia.…”