Scoping review to evaluate existing measurement parameters and clinical outcomes of transtibial prosthetic alignment and socket fit

Abstract

Introduction: Fit and alignment are observable objectives of the prosthesis rendering process for individuals with lower limb amputation. Nevertheless, there is a dearth of validated measures to directly assess the quality of this clinical procedure.Objectives: The objectives of this scoping review are to evaluate existing measurement parameters and clinical outcomes used in investigations of transtibial socket fit or prosthetic alignment and to identify gaps in the literature regarding tools for evaluation of prosthetic fitting. Study design: Scoping literature review. Methods: A comprehensive search was conducted in the following databases: MEDLINE (through PubMed), Embase (through Elsevier), Scopus (through Elsevier), and Engineering Village (through Elsevier), resulting in 6107 studies to be screened. Results: Sixty-three studies were included in the review. When measuring fit, studies most frequently reported on patient-reported comfort (n 5 22) and socket size compared with the residual limb volume (n 5 9). Alignment was most frequently measured by the prosthetists' judgment and/or use of an alignment jig (n 5 34). The measurement parameters used to determine alignment or fit varied greatly among the included studies. Conclusion: This review demonstrated that most measures of socket fit rely on a patient's self-report and may vary with biopsychosocial factors unrelated to the socket fitting process. Meanwhile, alignment is determined mostly by the prosthetist's judgment, paired with objective measurements, such as alignment jigs and gait analysis. Efforts to standardize and validate measures of these parameters of prosthetic fitting are vital to improving clinical practice and reporting outcomes.

Development of a prosthetic fit and alignment assessment (ProFit) in persons with post-traumatic transtibial amputation

“…The findings of a recent scoping review of clinical studies concerned with transtibial socket fit and/or prosthesis alignment highlighted a lack of consensus on conventions used in measuring these parameters. 14 There was a heavy reliance on patient feedback and the experience of a prosthetist. Sixteen of 30 studies that mentioned alignment measurement conducted by prosthetists did not specify the tools or parameters that were used, and only 8 paired the prosthetist's Six CPOs rated each item regarding the importance to assessing prosthetic fit and alignment on a scale of 0 (not important at all) to 4 (very important).…”

“…Alignment is defined as the placement and orientation of the prosthetic components in relation to the weight-bearing axis during stance and gait. According to our previously described conceptual model (Figure 1), 14 fit and alignment are outcomes of prosthesis rendering, which are influenced by baseline patient, injury, and surgical factors; and that influence downstream function, performance, or other patient-reported outcomes. The instrument was developed using commonly used clinical assessments that could also be scored remotely by prosthetists using images and video data that can be captured during a follow-up research encounter.…”

“…A recent scoping review of studies that included clinical outcomes of people with transtibial amputation where socket fit and prosthetic alignment were measured reported that many studies failed to describe the parameters used to make these measurements and those that did most often used patient-reported instruments assessing self-perception, satisfaction, and comfort, or prosthetist judgment supplemented by patient feedback or gait analysis. 14 Current published methods to measure socket fit and prosthetic alignment are rarely standardized, validated, or quantitative.…”

Inertial Measuring System to Evaluate Gait Parameters and Dynamic Alignments for Lower-Limb Amputation Subjects

“…To judge if the prosthesis fits is, however, a challenge. Until now, the appropriateness of a prosthesis is subjectively reported by amputees; meanwhile, how well-aligned a prosthesis is is always observed by a prosthetist [ 11 ]. The definition of alignment for a prosthesis user is the relative motion between the socket and the other parts of a prosthesis [ 12 ].…”

“…The definition of alignment for a prosthesis user is the relative motion between the socket and the other parts of a prosthesis [ 12 ]. With good feasibility, the alignments after wearing a prosthesis have been always subjectively clarified by a prosthetist [ 11 ]. To handle this issue, the alignments, gait parameters, and the symmetry of gaits have been taken as objective variables to show a good fit for a prosthesis [ 11 , 12 ].…”