Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis

Larry E Miller,1 Angela K Zimmermann,1 William G Herbert,1,2 1Miller Scientific Consulting, Inc., Asheville, NC, 2Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, VA, USA Background: Powered exoskeletons are designed to safely facilitate ambulation in patients with spi...

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Autores principales: Miller LE, Zimmermann AK, Herbert WG
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Publicado: Dove Medical Press 2016
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spelling oai:doaj.org-article:a364ac185ff44683bf88156e208f04b02021-12-02T08:17:25ZClinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis1179-1470https://doaj.org/article/a364ac185ff44683bf88156e208f04b02016-03-01T00:00:00Zhttps://www.dovepress.com/clinical-effectiveness-and-safety-of-powered-exoskeleton-assisted-walk-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Larry E Miller,1 Angela K Zimmermann,1 William G Herbert,1,2 1Miller Scientific Consulting, Inc., Asheville, NC, 2Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, VA, USA Background: Powered exoskeletons are designed to safely facilitate ambulation in patients with spinal cord injury (SCI). We conducted the first meta-analysis of the available published research on the clinical effectiveness and safety of powered exoskeletons in SCI patients. Methods: MEDLINE and EMBASE databases were searched for studies of powered exoskeleton-assisted walking in patients with SCI. Main outcomes were analyzed using fixed and random effects meta-analysis models. Results: A total of 14 studies (eight ReWalk™, three Ekso™, two Indego®, and one unspecified exoskeleton) representing 111 patients were included in the analysis. Training programs were typically conducted three times per week, 60–120 minutes per session, for 1–24 weeks. Ten studies utilized flat indoor surfaces for training and four studies incorporated complex training, including walking outdoors, navigating obstacles, climbing and descending stairs, and performing activities of daily living. Following the exoskeleton training program, 76% of patients were able to ambulate with no physical assistance. The weighted mean distance for the 6-minute walk test was 98 m. The physiologic demand of powered exoskeleton-assisted walking was 3.3 metabolic equivalents and rating of perceived exertion was 10 on the Borg 6–20 scale, comparable to self-reported exertion of an able-bodied person walking at 3 miles per hour. Improvements in spasticity and bowel movement regularity were reported in 38% and 61% of patients, respectively. No serious adverse events occurred. The incidence of fall at any time during training was 4.4%, all occurring while tethered using a first-generation exoskeleton and none resulting in injury. The incidence of bone fracture during training was 3.4%. These risks have since been mitigated with newer generation exoskeletons and refinements to patient eligibility criteria. Conclusion: Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to yield health benefits. Keywords: ambulation, Ekso, Indego, orthosis, ReWalk, SCIMiller LEZimmermann AKHerbert WGDove Medical PressarticleambulationEksoIndegoorthosispowered exoskeletonReWalkspinal cord injuryMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2016, Iss Issue 1, Pp 455-466 (2016)
institution DOAJ
collection DOAJ
language EN
topic ambulation
Ekso
Indego
orthosis
powered exoskeleton
ReWalk
spinal cord injury
Medical technology
R855-855.5
spellingShingle ambulation
Ekso
Indego
orthosis
powered exoskeleton
ReWalk
spinal cord injury
Medical technology
R855-855.5
Miller LE
Zimmermann AK
Herbert WG
Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis
description Larry E Miller,1 Angela K Zimmermann,1 William G Herbert,1,2 1Miller Scientific Consulting, Inc., Asheville, NC, 2Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, VA, USA Background: Powered exoskeletons are designed to safely facilitate ambulation in patients with spinal cord injury (SCI). We conducted the first meta-analysis of the available published research on the clinical effectiveness and safety of powered exoskeletons in SCI patients. Methods: MEDLINE and EMBASE databases were searched for studies of powered exoskeleton-assisted walking in patients with SCI. Main outcomes were analyzed using fixed and random effects meta-analysis models. Results: A total of 14 studies (eight ReWalk™, three Ekso™, two Indego®, and one unspecified exoskeleton) representing 111 patients were included in the analysis. Training programs were typically conducted three times per week, 60–120 minutes per session, for 1–24 weeks. Ten studies utilized flat indoor surfaces for training and four studies incorporated complex training, including walking outdoors, navigating obstacles, climbing and descending stairs, and performing activities of daily living. Following the exoskeleton training program, 76% of patients were able to ambulate with no physical assistance. The weighted mean distance for the 6-minute walk test was 98 m. The physiologic demand of powered exoskeleton-assisted walking was 3.3 metabolic equivalents and rating of perceived exertion was 10 on the Borg 6–20 scale, comparable to self-reported exertion of an able-bodied person walking at 3 miles per hour. Improvements in spasticity and bowel movement regularity were reported in 38% and 61% of patients, respectively. No serious adverse events occurred. The incidence of fall at any time during training was 4.4%, all occurring while tethered using a first-generation exoskeleton and none resulting in injury. The incidence of bone fracture during training was 3.4%. These risks have since been mitigated with newer generation exoskeletons and refinements to patient eligibility criteria. Conclusion: Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to yield health benefits. Keywords: ambulation, Ekso, Indego, orthosis, ReWalk, SCI
format article
author Miller LE
Zimmermann AK
Herbert WG
author_facet Miller LE
Zimmermann AK
Herbert WG
author_sort Miller LE
title Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis
title_short Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis
title_full Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis
title_fullStr Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis
title_full_unstemmed Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis
title_sort clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis
publisher Dove Medical Press
publishDate 2016
url https://doaj.org/article/a364ac185ff44683bf88156e208f04b0
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AT herbertwg clinicaleffectivenessandsafetyofpoweredexoskeletonassistedwalkinginpatientswithspinalcordinjurysystematicreviewwithmetaanalysis
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