A Scoping Review of Minimal Important Change and Minimal Detectable Change of the Fugl-Meyer Assessment Lower Extremity Scale in Patients with Stroke.

Objectives: In stroke rehabilitation, the Fugl-Meyer Assessment Lower Extremity (FMA-LE) motor scale is widely used to assess consecutive recovery steps from motor paralysis and predict prognosis after stroke. However, there has been limited opportunity to refer to the useful yet few studies that evaluated the minimal important change (MIC) and the minimal detectable change (MDC) of the FMA-LE motor scale. The aims of this review were to: (1) identify studies that have estimated the MIC and MDC, (2) identify the calculated MIC and MDC values and disease phases in previous studies, and (3) assess the methodological quality of the MIC and MDC studies of the FMA-LE motor scale.

Methods: A scoping review was undertaken following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) recommendations. 3 databases (PubMed, CINAHL, and Web of Science) were used for the literature search. Reports of the MIC and MDC of the FMA-LE motor scale in patients with stroke were selected.

Results: 6 studies were included after confirming their eligibility. In the acute phase, inter-rater MDC was 3.23 points. In the early subacute phase, intra-rater MDC was 1.24 points. In the chronic phase, intra-rater MDC was 3.80, 4.87, and 7.98 points, inter-rater MDC was 3.57 and 5.96 points, and MIC was 6.00 points.

Conclusion: No late subacute threshold was identified for the MDC, and no acute or subacute threshold was identified for the MIC. Compared with the quality of the MIC study, there is room for improvement in the quality of the MDC studies with respect to study design.