A powered exoskeleton consists of an exoskeleton-like framework worn by an individual and a power source that supplies the energy for limb movement. The goal of the powered exoskeleton is to enable people who do not have volitional (i.e., willing) movement of their lower extremities to be able to fully bear weight while standing, to walk and to navigate stairs. The devices reportedly have the potential to restore mobility and, thus, may lead to improvements in functional status, quality of life and health status for individuals with spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, Guillain-Barre syndrome and spina bifida.
Two powered exoskeleton devices have received marketing clearance by the FDA for personal use. They are the Rewalk™ Personal and the Indego®.
Use of a powered exoskeleton for ambulation in individuals with lower-limb disabilities is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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The evidence for the powered exoskeleton in individuals who have lower-limb disabilities is limited to small studies performed in the laboratory setting under close supervision. Further study is required to evaluate the effectiveness and safety of lower limb exoskeletons in the community.
Asselin, P., Knezevic, S., Kornfeld, S., Cirnigliaro, C., Agranova-Breyter, I., Bauman, W., & Spungen,A. (2015). Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. Journal of Rehabilitation Research & Development, 52 (2), 147-158. (Level 4 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (3:2017). Powered Exoskeleton for Ambulation in Patients with Lower-Limb Disabilities (1.03.04). Retrieved October 30, 2018 from http://www.evidencepositioningsystem.com. (7 articles and/or guidelines reviewed)
ECRI Institute. Emerging Technology Evidence Report. (2016, April). Wearable Powered Exoskeleton use after Spinal Cord Injury. Retrieved April 28, 2016 from ECRI Institute. (148 articles and/or guidelines reviewed)
Federici, S., Meloni, F., Bracalenti, M., & DeFilippis, M.L. (2015). The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation: a systematic review. NeuroRehabilitation, 37 (3), 321-340. Abstract retrieved January 24, 208 from PubMed database.
Hartigan, C., Kandilakis, C., Dalley,S., Clausen, M., Wilson, E., Morrison, S., et al. (2015). Mobility outcomes following five training sessions with a powered exoskeleton. Topics in Spinal Cord Injury Rehabilitation, 21 (2), 93-99. (Level 4 evidence)
Lajeunesse, V., Vincent, C., Routhier, F., Careau, E., & Michaud, F. (2016). Exoskeletons’ design and usefulness evidence according to a systemic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. Disability Rehabilitation. Assistive Technology, 11 (7), 535-547. Abstract retrieved January 24, 2018 from PubMed database.
Lonini, L., Shawen, N., Scanlan, K., Rymer, W., Kording, K., and Jayaraman, A. (2016). Accelerometry-enabled measurement of walking performance with a robotic exoskeleton: a pilot study. Journal of NeuroEngineering and Rehabilitation, (2016) 13:35. (Level 4 evidence)
Miller, L., Zimmermann, A., & Herbert, W. (2016). Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. Medical Devices: Evidence and Research, 2016: 9, 455-466. (Level 2 evidence)
National Institute for Health and Care Excellence (2017, January). Medtech innovation briefing: Ekso exoskeleton for rehabilitation in people with neurological weakness or paralysis. Retrieved February 2, 2017 from http://nice.org.uk/guideance/mib93.
U. S. Food and Drug Administration. (2013, June). De Novo Summary (K131798). Evaluation of Automatic Class III Designation (De Novo) for ARGO ReWalk™. Retrieved March 17, 2015 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2016, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K152416. Retrieved May 2, 2016 from http://www.accessdata.fda.gov.
Yang, A., Asselin, P., Knezevic, S., Kornfeld, S., & Spungen, A. (2015). Assessment of in-hospital walking velocity and level of assistance in a powered exoskeleton in persons with spinal cord injury. Topics in Spinal Cord Injury Rehabilitation, 21 (2), 100-109. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 8/8/2015
MOST RECENT REVIEW DATE: 1/10/2019
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