Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Background

Robotic lower-limb exoskeletons have the potential to provide additional clinical benefits for persons with spinal cord injury (SCI). However, high variability between protocols does not allow the comparison of study results on safety and feasibility between different exoskeletons. We therefore incorporated key aspects from previous studies into our study protocol and accordingly conducted a multicentre study investigating the safety, feasibility and usability of the ABLE Exoskeleton in clinical settings.

Methods

In this prospective pretest-posttest quasi-experimental study across two SCI centres in Germany and Spain, in- and outpatients with SCI were recruited into a 12-session training and assessment protocol, utilising the ABLE Exoskeleton. A follow-up visit after 4 weeks was included to assess after-training outcomes. Safety outcomes (device-related adverse events (AEs), number of drop-outs), feasibility and usability measures (level of assistance, donning/doffing-time) were recorded at every session together with changes in gait parameters and function. Patient-reported outcome measures including the rate of perceived exertion (RPE) and the psychosocial impact of the device were performed. Satisfaction with the device was evaluated in both participants and therapists.

Results

All 24 participants (45 ± 12 years), with mainly subacute SCI (< 1 year after injury) from C5 to L3, (ASIA Impairment Scale A to D) completed the follow-up. In 242 training sessions, 8 device-related AEs (pain and skin lesions) were reported. Total time for don and doff was 6:50 ± 2:50 min. Improvements in level of assistance and gait parameters (time, steps, distance and speed, p < 0.05) were observed in all participants. Walking function and RPE improved in participants able to complete walking tests with (n = 9) and without (n = 6) the device at study start (p < 0.05). A positive psychosocial impact of the exoskeleton was reported and the satisfaction with the device was good, with best ratings in safety (participants), weight (therapists), durability and dimensions (both).

Conclusions

Our study results prove the feasibility of safe gait training with the ABLE Exoskeleton in hospital settings for persons with SCI, with improved clinical outcomes after training. Our study protocol allowed for consistent comparison of the results with other exoskeleton trials and can serve as a future framework towards the standardisation of early clinical evaluations.

Trial Registration https://trialsearch.who.int/, DRKS00023503, retrospectively registered on November 18, 2020.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12984-023-01165-0.

Related collections

Most cited references 31

Record: found
Abstract: found
Article: found

Is Open Access

Global prevalence and incidence of traumatic spinal cord injury

Anoushka Singh, Lindsay Tetreault, Suhkvinder Kalsi-Ryan … (2014)

Background Spinal cord injury (SCI) is a traumatic event that impacts a patient’s physical, psychological, and social well-being and places substantial financial burden on health care systems. To determine the true impact of SCI, this systematic review aims to summarize literature reporting on either the incidence or prevalence of SCI. Methods A systematic search was conducted using PubMed, MEDLINE, MEDLINE in process, EMBASE, Cochrane Controlled Trial Register, and Cochrane Database of Systematic Reviews to identify relevant literature published through June 2013. We sought studies that provided regional, provincial/state, or national data on the incidence of SCI or reported estimates of disease prevalence. The level of evidence of each study was rated using a scale that evaluated study design, methodology, sampling bias, and precision of estimates. Results The initial search yielded 5,874 articles, 48 of which met the inclusion criteria. Forty-four studies estimated the incidence of SCI and nine reported the prevalence, with five discussing both. Of the incidence studies, 14 provided figures at a regional, ten at a state or provincial level and 21 at a national level. The prevalence of SCI was highest in the United States of America (906 per million) and lowest in the Rhone-Alpes region, France (250 per million) and Helsinki, Finland (280 per million). With respect to states and provinces in North America, the crude annual incidence of SCI was highest in Alaska (83 per million) and Mississippi (77 per million) and lowest in Alabama (29.4 per million), despite a large percentage of violence injuries (21.2%). Annual incidences were above 50 per million in the Hualien County in Taiwan (56.1 per million), the central Portugal region (58 per million), and Olmsted County in Minnesota (54.8 per million) and were lower than 20 per million in Taipei, Taiwan (14.6 per million), the Rhone-Alpes region in France (12.7 per million), Aragon, Spain (12.1 per million), Southeast Turkey (16.9 per million), and Stockholm, Sweden (19.5 per million). The highest national incidence was 49.1 per million in New Zealand, and the lowest incidences were in Fiji (10.0 per million) and Spain (8.0 per million). The majority of studies showed a high male-to-female ratio and an age of peak incidence of younger than 30 years old. Traffic accidents were typically the most common cause of SCI, followed by falls in the elderly population. Conclusion This review demonstrates that the incidence, prevalence, and causation of SCI differs between developing and developed countries and suggests that management and preventative strategies need to be tailored to regional trends. The rising aging population in westernized countries also indicates that traumatic SCI secondary to falls may become an increasing public health challenge and that incidence among the elderly may rise with increasing life expectancy.

0 comments Cited 312 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Inter- and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-analysis.

Ana-Belén Meseguer-Henarejos, Julio Sánchez-Meca, José-Antonio López-Pina … (2018)

The Modified Ashworth Scale is the most widely clinical scale used to measure the increase of muscle tone. Reliability is not an immutable property of a scale and can vary as a function of the variability and composition of the sample to which it is administered. The best method to examine how the reliability of a test scores varies is by conducting a systematic review and meta-analysis of the reliability coefficients obtained in different applications of the test with the data at hand. The objectives of this systematic revision are: what is the mean inter- and intra-rater reliability of the Modified Ashworth Scale's scores in upper and lower extremities? Which study characteristics affect the reliability of the scores in this scale?

0 comments Cited 116 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: not found
Article: not found

International Standards for Neurological Classification of Spinal Cord Injury

Rüdiger Rupp, Fin Biering-Sørensen, Stephen Burns … (2021)

0 comments Cited 68 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Rüdiger Rupp: ruediger.rupp@med.uni-heidelberg.de

Journal

Journal ID (nlm-ta): J Neuroeng Rehabil

Journal ID (iso-abbrev): J Neuroeng Rehabil

Title: Journal of NeuroEngineering and Rehabilitation

Publisher: BioMed Central (London )

ISSN (Electronic): 1743-0003

Publication date (Electronic): 12 April 2023

Publication date PMC-release: 12 April 2023

Publication date Collection: 2023

Volume: 20

Electronic Location Identifier: 45

Affiliations

[1 ]GRID grid.7080.f, ISNI 0000 0001 2296 0625, Institut Guttmann, , University Institute attached to the Universitat Autònoma de Barcelona, ; Badalona, Barcelona Spain

[2 ]GRID grid.7080.f, ISNI 0000 0001 2296 0625, Universitat Autònoma de Barcelona, ; Bellaterra, Cerdanyola del Vallès, Spain

[3 ]GRID grid.429186.0, ISNI 0000 0004 1756 6852, Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol, ; Badalona, Barcelona Spain

[4 ]GRID grid.5253.1, ISNI 0000 0001 0328 4908, Spinal Cord Injury Center, , Heidelberg University Hospital, ; Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany

[5 ]ABLE Human Motion S.L., Barcelona, Spain

Article

Publisher ID: 1165

DOI: 10.1186/s12984-023-01165-0

PMC ID: 10091314

PubMed ID: 37046307

SO-VID: e9ea3bc4-135d-4ece-b764-1ca1754ec21d

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 7 June 2022

Date accepted : 30 March 2023

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100014419, EIT Health;

Award ID: 20121 ABLE Exoskeleton

Funded by: Universitätsklinikum Heidelberg (8914)

Custom metadata

ScienceOpen disciplines: Neurosciences

Keywords: spinal cord injury,spinal cord disorder,exoskeleton,rehabilitation,robotics,safety,feasibility,usability,gait,study protocol,standardisation

Data availability:

ScienceOpen disciplines: Neurosciences

Keywords: spinal cord injury, spinal cord disorder, exoskeleton, rehabilitation, robotics, safety, feasibility, usability, gait, study protocol, standardisation

Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations

Read this article at

Abstract

Background

Methods

Results

Conclusions

Supplementary Information

Related collections

Behavioral phenotypization of a mouse model for Alzheimer's: PDAPP = Tg(APPV717F)109Ili

Most cited references 31

Global prevalence and incidence of traumatic spinal cord injury

Inter- and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-analysis.

International Standards for Neurological Classification of Spinal Cord Injury

Author and article information

Contributors

Journal

Affiliations

Article

History

Funding

Categories

Custom metadata

Comments

Comment on this article

Similar content 699

Most referenced authors 368