Guidelines and Recommendations to Investigate the Efficacy of a Lower-Limb Prosthetic Device: A Systematic Review

Introduction Evaluating the efficacy of a lower-limb prosthetic device (LLPD) is a crucial step in the iterative process of redesigning and product development of new generation prostheses. To date, no standardized experimental methodology for the evaluation of LLPDs is available which complicates the comparison of results. Objective This systematic review provides an overview of study designs, tests and outcome measures to evaluate a LLPD. Ultimately, guidelines and recommendations are formulated. Methods Two databases were screened on studies evaluating a LLPD, published between 2009 and 2019. Results 109 articles were eventually included. We identified 43 outcome measures in four main categories: 53% were biomechanical, 26% physiological, 14% physical performance and 7% psychological. Mainly walking tests were included (78%), of which 31% were performed on a slope, followed by stair climbing (15%) and other functional tasks (15%). Conclusion An overview of currently used study designs and experimental protocols is presented, which led to guidelines and recommendations for the evaluation of a LLPD. The main recommendation is to include daily activities in a case-report and in a later stage in a randomized controlled study design. Biomechanical, physiological, physical performance and psychological outcome measures are key for the evaluation of a LLPD.