Motl Robert W, Cohen Jeffrey A, Benedict Ralph, Phillips Glenn, LaRocca Nicholas, Hudson Lynn D, Rudick Richard
Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.
Mellen Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Mult Scler. 2017 Apr;23(5):704-710. doi: 10.1177/1352458517690823. Epub 2017 Feb 16.
The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with multiple sclerosis (MS). One of the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful in MS. This article addresses the history, application, and psychometric properties of one such MSOAC metric of ambulation or walking namely, the timed 25-foot walk (T25FW). The T25FW has strong reliability over both brief and long periods of time in MS across a large range of disability levels. The outcome of walking speed from the T25FW has obvious real-world relevance and has correlated strongly with other measures of walking and lower extremity function. The T25FW is responsive for capturing intervention effects in pharmacological and rehabilitation trials and has an established value for capturing clinically meaningful change in ambulation. Directions for future research involve validating clinically meaningful improvements on the T25FW as well as determining whether 20% change is clinically meaningful across the disability spectrum. Researchers might further consider synchronizing accelerometers and motion sensors with the T25FW for capturing walking speed in everyday life and the patient's real environment.
多发性硬化症疗效评估联盟(MSOAC)包括来自倡导组织、美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)、国立神经疾病与中风研究所(NINDS)、学术机构、行业合作伙伴的代表,以及多发性硬化症(MS)患者。MSOAC的目标之一是让监管机构认可并鉴定出在MS中高度可靠、有效、实用、具有成本效益且有意义的性能指标。本文探讨了一种MSOAC步行或行走指标,即25英尺计时步行(T25FW)的历史、应用和心理测量特性。T25FW在MS患者中,无论残疾程度如何,在短时间和长时间内都具有很强的可靠性。T25FW得出的步行速度结果具有明显的现实意义,并且与其他步行和下肢功能测量指标密切相关。T25FW在药理学和康复试验中能够有效捕捉干预效果,并且在捕捉步行方面具有临床意义的变化方面具有既定价值。未来的研究方向包括验证T25FW在临床上有意义的改善情况,以及确定20%的变化在整个残疾范围内是否具有临床意义。研究人员可能还会进一步考虑将加速度计和运动传感器与T25FW同步,以捕捉日常生活和患者真实环境中的步行速度。