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

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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 fo