Testing and evaluation of lower limb prosthesis prototypes in people with a transfemoral amputation: a scoping review on research protocols.
Design
Development
Evaluation
Prosthetics
Protocol
Prototype
Testing
Transfemoral
Journal
Journal of neuroengineering and rehabilitation
ISSN: 1743-0003
Titre abrégé: J Neuroeng Rehabil
Pays: England
ID NLM: 101232233
Informations de publication
Date de publication:
12 01 2023
12 01 2023
Historique:
received:
27
05
2022
accepted:
07
01
2023
entrez:
12
1
2023
pubmed:
13
1
2023
medline:
17
1
2023
Statut:
epublish
Résumé
When developing new lower limb prostheses, prototypes are tested to obtain insights into the performance. However, large variations between research protocols may complicate establishing the potential added value of newly developed prototypes over other prostheses. This review aims at identifying participant characteristics, research protocols, reference values, aims, and corresponding outcome measures used during prosthesis prototype testing on people with a transfemoral amputation. A systematic search was done on PubMed and Scopus from 2000 to December 2020. Articles were included if testing was done on adults with transfemoral or knee disarticulation amputation; testing involved walking with a non-commercially available prototype leg prosthesis consisting of at least a knee component; and included evaluations of the participants' functioning with the prosthesis prototype. From the initial search of 2027 articles, 48 articles were included in this review. 20 studies were single-subject studies and 4 studies included a cohort of 10 or more persons with a transfemoral amputation. Only 5 articles reported all the pre-defined participant characteristics that were deemed relevant. The familiarization time with the prosthesis prototype prior to testing ranged from 5 to 10 min to 3 months; in 25% of the articles did not mention the extent of the familiarization period. Mobility was most often mentioned as the development or testing aim. A total of 270 outcome measures were identified, kinetic/kinematic gait parameters were most often reported. The majority of outcome measures corresponded to the mobility aim. For 48% of the stated development aims and 4% of the testing aims, no corresponding outcome measure could be assigned. Results indicated large inconsistencies in research protocols and outcome measures used to validate pre-determined aims. The large variation in prosthesis prototype testing and reporting calls for the development of a core set of reported participant characteristics, testing protocols, and specific and well-founded outcome measures, tailored to the various aims and development phases. The use of such a core set can give greater insights into progress of developments and determine which developments have additional benefits over the state-of-the-art. This review may contribute as initial input towards the development of such a core set.
Sections du résumé
BACKGROUND
When developing new lower limb prostheses, prototypes are tested to obtain insights into the performance. However, large variations between research protocols may complicate establishing the potential added value of newly developed prototypes over other prostheses.
OBJECTIVE
This review aims at identifying participant characteristics, research protocols, reference values, aims, and corresponding outcome measures used during prosthesis prototype testing on people with a transfemoral amputation.
METHODS
A systematic search was done on PubMed and Scopus from 2000 to December 2020. Articles were included if testing was done on adults with transfemoral or knee disarticulation amputation; testing involved walking with a non-commercially available prototype leg prosthesis consisting of at least a knee component; and included evaluations of the participants' functioning with the prosthesis prototype.
RESULTS
From the initial search of 2027 articles, 48 articles were included in this review. 20 studies were single-subject studies and 4 studies included a cohort of 10 or more persons with a transfemoral amputation. Only 5 articles reported all the pre-defined participant characteristics that were deemed relevant. The familiarization time with the prosthesis prototype prior to testing ranged from 5 to 10 min to 3 months; in 25% of the articles did not mention the extent of the familiarization period. Mobility was most often mentioned as the development or testing aim. A total of 270 outcome measures were identified, kinetic/kinematic gait parameters were most often reported. The majority of outcome measures corresponded to the mobility aim. For 48% of the stated development aims and 4% of the testing aims, no corresponding outcome measure could be assigned. Results indicated large inconsistencies in research protocols and outcome measures used to validate pre-determined aims.
CONCLUSIONS
The large variation in prosthesis prototype testing and reporting calls for the development of a core set of reported participant characteristics, testing protocols, and specific and well-founded outcome measures, tailored to the various aims and development phases. The use of such a core set can give greater insights into progress of developments and determine which developments have additional benefits over the state-of-the-art. This review may contribute as initial input towards the development of such a core set.
Identifiants
pubmed: 36635703
doi: 10.1186/s12984-023-01125-8
pii: 10.1186/s12984-023-01125-8
pmc: PMC9835280
doi:
Types de publication
Journal Article
Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1Informations de copyright
© 2023. The Author(s).
Références
Proc IEEE RAS EMBS Int Conf Biomed Robot Biomechatron. 2008 Oct 19;2008:523-528
pubmed: 20648239
South Med J. 2002 Aug;95(8):875-83
pubmed: 12190225
Sensors (Basel). 2018 Feb 27;18(3):
pubmed: 29495495
Technol Health Care. 2018;26(4):581-592
pubmed: 29710741
Prosthet Orthot Int. 2011 Jun;35(2):163-70
pubmed: 21697198
Acta Bioeng Biomech. 2019;21(3):135-142
pubmed: 31798017
Disabil Rehabil. 2021 Jul;43(14):1982-1988
pubmed: 31724882
Prosthet Orthot Int. 2013 Aug;37(4):305-10
pubmed: 23327835
IEEE Trans Biomed Eng. 2011 Aug;58(8):
pubmed: 21592917
Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:3198-3201
pubmed: 30441073
Front Neurosci. 2018 Mar 22;12:134
pubmed: 29623025
Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:8519-22
pubmed: 22256326
Prosthet Orthot Int. 2016 Aug;40(4):490-6
pubmed: 26209423
Clin Biomech (Bristol, Avon). 2014 Mar;29(3):235-42
pubmed: 24393361
Proc Inst Mech Eng H. 2009 Feb;223(2):263-71
pubmed: 19278201
Arch Phys Med Rehabil. 2017 Jul;98(7):1389-1399
pubmed: 27865845
J Neuroeng Rehabil. 2016 Jun 10;13(1):54
pubmed: 27283318
Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:1821-1824
pubmed: 30440749
J Rehabil Res Dev. 2014;51(4):623-34
pubmed: 25144175
Front Neurorobot. 2018 Dec 04;12:80
pubmed: 30564111
IEEE Int Conf Rehabil Robot. 2017 Jul;2017:1160-1164
pubmed: 28813978
J Rehabil Res Dev. 2016;53(6):1079-1088
pubmed: 28355031
IEEE ASME Trans Mechatron. 2020 Feb;25(1):175-184
pubmed: 33746502
Ann Intern Med. 2018 Oct 2;169(7):467-473
pubmed: 30178033
IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650352
pubmed: 24187171
Phys Ther. 2016 Dec;96(12):1896-1904
pubmed: 27277497
J Neurosci. 2014 Oct 1;34(40):13411-21
pubmed: 25274819
Arch Phys Med Rehabil. 2005 Nov;86(11):2119-25
pubmed: 16271558
IEEE ASME Trans Mechatron. 2009;14(6):667-676
pubmed: 20054424
Prosthet Orthot Int. 2018 Apr;42(2):214-222
pubmed: 28655287
Acta Bioeng Biomech. 2018;20(4):33-40
pubmed: 30821287
IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650406
pubmed: 24187225
J Neuroeng Rehabil. 2018 Jan 03;15(1):3
pubmed: 29298695
IEEE Trans Neural Syst Rehabil Eng. 2009 Aug;17(4):390-6
pubmed: 19497830
Disabil Rehabil. 2017 Jan;39(2):143-151
pubmed: 26458225
J Rehabil Res Dev. 2015;52(1):1-19
pubmed: 26186283
Gait Posture. 2017 Oct;58:41-45
pubmed: 28711652
Disabil Rehabil Assist Technol. 2018 Feb;13(2):157-165
pubmed: 28399722
Disabil Rehabil Assist Technol. 2021 Jan;16(1):40-48
pubmed: 31349766
J Rehabil Res Dev. 2004 Sep;41(5):675-82
pubmed: 15558397