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

Abstract

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.

Intrinsic Axonal Growth and the Drive for Regeneration

“…Interestingly, these studies revealed significant interspecies differences in the mechanisms of corticospinal tract regeneration during motor recovery when comparing rodents to primates and humans. Finally, combinatorial and holistic approaches that incorporate rehabilitation, pharmacology, neuromodulation (Moraud et al, 2016; Wenger et al, 2016) as well as emerging technologies like the exoskeleton (Gad et al, 2015; Miller et al, 2016) raise hopes that meaningful, functional recovery is achievable in the foreseeable future.…”

Варіативність Кореляції Рівня Функції Та Спастичності Паретичної Кінцівки За Різного Перебігу Відновного Процесу На Моделі Спінальної Травми

“…Незважаючи на значну біомедичну та соціально-економічну вагу про-блеми спінальної травми [1][2][3], тривалу зацікав-леність наукової спільноти питаннями віднов-лення функції ураженого спинного мозку [4][5][6][7], багато питань цього кола залишаються невивче-ними. Травма спинного мозку перебуває в аван-гарді сучасної біо технологічної галузі, до її вирі-шення залучаються найновіші розробки біонічно-го (нейропротезування, екзоскелетування) [8][9][10], біогенного (тканинна нейроінженерія) [11][12][13][14] та комплексного [15] характеру. Одними із най-складніших, з патофізіологічної точки зору, пи-тань є механізми формування синдрому спас-тичності, який виявляють у 45-78 % спінальних хворих [16][17][18][19].…”

Letter to the editor regarding "Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis"

“…In the article “Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis”, published in the March issue of Medical Devices: Evidence and Research , Miller et al1 present a meta-analysis of the clinical effectiveness and safety of powered exoskeletons for spinal cord injury (SCI) patients. A close examination of this article shows surprising coincidences, in that two primary studies (references 25 and 33 in the reference list) report the same proportions and 95% confidence intervals (CIs) of subjects able to ambulate with an exoskeleton without assistance (Figure 2 of the study), and two different primary studies (references 26 and 28) report the same mean and 95% CIs for the distance (in meters) walked in a 6-minute walk test (Figure 4 of the study).…”

“…In fact, nine of the 14 studies included in the meta-analysis by Miller et al1 can be assigned to three groups of studies that may contain duplicate patient information: New York City: references 23, 27, 32, and 34Philadelphia: references 25, 33, and 35Atlanta: references 26 and 27…”

“…Therefore, it is clear that the chances that these studies contain information on unique individuals are infinitesimally small. Miller et al1 should have noted the overlap in author names, investigated the uniqueness of each case series, and followed up with the investigators.…”