A Standardized Approach to the Fugl-Meyer Assessment and Its Implications for Clinical Trials

Abstract

Training with the current method improved accuracy, and reduced variance, of FMA scoring; the 20% FMA variance reduction with training would decrease sample size requirements from 137 to 88 in a theoretical trial aiming to detect a 7-point FMA difference. Minimal detectable change was much smaller than FMA minimal clinically important difference. The variation in FMA gains in relation to baseline FMA suggests that future trials consider a sliding outcome approach when FMA is an outcome measure. The current training approach may be useful for assessing motor outcomes in restorative stroke trials.

The Test-Retest Reliability and Minimal Detectable Change of the Fugl-Meyer Assessment of the Upper Extremity and 9-Hole Pegboard Test in Individuals With Subacute Stroke

“…According to previous studies, this intraday and interday reliability had high confidence interval (95% CI) [27][28][29][30]. Stanford et al assessed within examiner reliability among 3 therapists in a day by using the original version of FMA and reported the ICC as 0.97 which is similar to the present study.…”

Standardized Measurement of Sensorimotor Recovery in Stroke Trials: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable

“…Assessor training is required for good clinical practice, and standardization of training and certification protocols has been shown to reduce variance in scoring, thereby increasing power and reducing trial costs. 54 We should note that this core set of measures may be insufficient to satisfy the needs for measuring outcomes for a specific stroke recovery or rehabilitation research question. Other outcomes may be added; however, we strongly recommend that researchers be judicious in their choice of additional measures, limit the number of outcomes assessed and identify, a priori, the primary outcome measure and power the trial accordingly.…”

Moving Rehabilitation Research Forward: Developing Consensus Statements for Rehabilitation and Recovery Research

“…Important achievements would be to standardise definitions for common terms (eg recovery), time-points of measurement and distinguish between different types of outcomes (47). Simply stated, our challenge is not just to agree a core set of measurements, but to consider what we need to measure and why, to improve rehabilitation and recovery trial methods (48,49).…”