A Standardized Approach to the Fugl-Meyer Assessment and Its Implications for Clinical Trials
A Standardized Approach to the Fugl-Meyer Assessment and Its Implications for Clinical Trials
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DOI：
10.1177/1545968313491000
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发表时间：
2013-10-01
影响因子：
4.2
通讯作者：
Cramer, Steven C.
中科院分区：
文献类型：
--
作者：
See, Jill;Dodakian, Lucy;Cramer, Steven C.
背景。标准化评分可减少变异性并提高准确性。描述和评估了 Fugl-Meyer 运动评估 (FMA) 的详细评分和训练方法，并考虑了对临床试验的影响。方法。制定了标准化的 FMA 评分方法和培训材料，包括手册、评分表、教学视频和患者视频。该方法的性能针对上肢部分进行了评估。结果。 31 名患者的评估者间和评估者内信度非常出色（组内相关系数 = 0.98-0.99），有效性非常出色（r = 0.74-0.93，P < .0001），并且最小可检测变化较低（3.2 分）。培训需要 1.5 小时，显着减少了 50 名学生之间的错误和方差，训练前 Arm FMA 分数与答案的偏差为 3.8 +/- 6.2 分，而训练后为 0.9 +/- 4.9 分。目前的方法已在第二阶段试验的培训中顺利实施。在接受机器人治疗的 66 名患者中，基线 FMA 评分高端和低端的 FMA 变化较小 (P < .01)。结论。使用当前方法进行训练提高了 FMA 评分的准确性并减少了方差；在旨在检测 7 点 FMA 差异的理论试验中，通过训练将 FMA 方差减少 20%，将样本量要求从 137 减少到 88。最小可检测变化远小于 FMA 最小临床重要差异。 FMA 增益相对于基线 FMA 的变化表明，当 FMA 是结果衡量指标时，未来的试验应考虑采用滑动结果方法。当前的训练方法可能有助于评估恢复性中风试验中的运动结果。
Background. 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.