Sensitivity to change and responsiveness of the Fugl-Meyer Assessment - Upper Extremity in individuals with moderate to severe acute stroke

Research

Objectives: The aims of this study were to determine the responsiveness and sensitivity of the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) in severe post-stroke individuals from the acute to subacute phase after stroke with standard clinical care.

Design: Secondary analysis of data from the Stroke Motor Rehabilitation and Recovery Study (SMaHRT), a natural history longitudinal cohort study (www.clinicaltrials.gov, NCR03485040). Data from the acute hospitalization and 6-week follow-up were included. Sensitivity to change was measured using Cohen’s effect size, standardized response means (SRM), standard error of measurement (SEM), and minimal detectable change (MDC). Responsiveness, or minimal clinically important difference (MCID), was estimated using receiver operating characteristic (ROC) curves.Setting: Inpatient stroke service at Massachusetts General Hospital (MGH)

Participants: Participants were included if they were admitted to the inpatient stroke service and had an FMA-UE score < 47 and complete data at 6-week follow-up (n=52).Interventions: n/aMain Outcome Measures: FMA-UE, Global Rating of Change Scale (GROC) - Arm Weakness, GROC - Overall Recovery, Modified Rankin Scale (mRS)

Results: Analysis using Cohen’s d and the SRM revealed large effect sizes, indicating high sensitivity to change, d = 0.90, 95%CI [0.58, 1.23], SRM = 1.10. Results for the SEM and MDC were 2.45 and 6.78, respectively. ROC analysis indicated that the change in FMA-UE scores was able to distinguish between participants who experience clinically meaningful change from those who did not based on participant-reported GROC scores and clinician-reported mRS scores. The AUC values were statistically significant at a p<0.05 level for the GROC Arm Weakness, GROC Recovery, and mRS anchors. The MCID estimates for the total sample were 13, 12, and 9 anchored to the GROC Arm Weakness, GROC recovery, and mRS, respectively.

Conclusions: The results of our study indicate that the estimated MCID for the FMA-UE in the acute to subacute phase for individuals with moderate to severe impairment is 13, supported by several anchors. These estimates will guide clinical decision-making in the care for acute stroke patients by helping to identify meaningful change in motor impairment that is both beyond measurement error and clinically meaningful. Author(s) Disclosures: n/a