Testing and evaluation of lower limb prosthesis prototypes in people with a transfemoral amputation: a scoping review on research protocols

Journal of NeuroEngineering and Rehabilitation

Review

Vivian Weerdesteyn¹  Nico Verdonschot²  Vera G. M. Kooiman³  Ruud A. Leijendekkers⁴  Eline S. van Staveren⁵  Erik C. Prinsen⁶  Jaap H. Buurke⁷ 

[1]Department of Rehabilitation, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

[2]Sint Maartenskliniek, Research & Rehabilitation, P.O. Box 9011, 6500 GM, Nijmegen, The Netherlands

[3]Orthopedic Research Laboratory, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

[4]Department of Biomechanical Engineering, Faculty of Engineering Technology, University of Twente, P.O. Box 217, 7500 AE, Enschede, The Netherlands

[5]Orthopedic Research Laboratory, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

[6]Department of Rehabilitation, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

[7]Orthopedic Research Laboratory, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

[8]Department of Rehabilitation, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

[9]Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

[10]Roessingh Research and Development, PO Box 310, 7500 AH, Enschede, The Netherlands

[11]Roessingh Research and Development, PO Box 310, 7500 AH, Enschede, The Netherlands

[12]Department of Biomechanical Engineering, Faculty of Engineering Technology, University of Twente, P.O. Box 217, 7500 AE, Enschede, The Netherlands

[13]Roessingh Research and Development, PO Box 310, 7500 AH, Enschede, The Netherlands

[14]Roessingh Center for Rehabilitation, Postbus 310, 7500 AH, Enschede, The Netherlands

[15]Department of Biomechanical Engineering, Faculty of Engineering Technology, University of Twente, P.O. Box 217, 7500 AE, Enschede, The Netherlands

关键词: Prosthetics;    Development;    Prototype;    Testing;    Protocol;    Transfemoral;    Evaluation;    Design;   

DOI  :  10.1186/s12984-023-01125-8

 received in 2022-05-27, accepted in 2023-01-07,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundWhen 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.ObjectiveThis 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.MethodsA 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.ResultsFrom 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.ConclusionsThe 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.

【 授权许可】

CC BY   
© The Author(s) 2023

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Fig. 4