Article

Standardizing scoring reduces variability and increases accuracy. A
detailed scoring and training method for the Fugl-Meyer motor assessment (FMA) is
described and assessed, and implications for clinical trials considered. METHODS:
A standardized FMA scoring approach and training materials were assembled,
including a manual, scoring sheets, and instructional video plus patient videos.
Performance of this approach was evaluated for the upper extremity portion.
RESULTS: Inter- and intrarater reliability in 31 patients were excellent
(intraclass correlation coefficient = 0.98-0.99), validity was excellent (r =
0.74-0.93, P < .0001), and minimal detectable change was low (3.2 points).
Training required 1.5 hours and significantly reduced error and variance among 50
students, with arm FMA scores deviating from the answer key by 3.8 +/- 6.2 points
pretraining versus 0.9 +/- 4.9 points posttraining. The current approach was
implemented without incident into training for a phase II trial. Among 66
patients treated with robotic therapy, change in FMA was smaller (P </= .01) at
the high and low ends of baseline FMA scores. CONCLUSIONS: 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.

Langue : ANGLAIS