Examining outcome measures in a clinical study of stroke.

Abstract

We investigated the relation between outcome and sample size for six selected stroke outcome measures to assist investigators in selecting end points for stroke studies. Data from a clinical trial of 167 stroke patients assessed shortly after admission to the hospital and 5 weeks later provided information on clinical, motor, and functional outcomes measured using a neurologic status scale, a stroke severity scale, the Fugl-Meyer Scale, the Barthel Index, and the activities of daily living and cognition subscales of the Level of Rehabilitation Scale. Data were examined using Pearson correlation coefficients and power analyses. All measures were significantly correlated. There was also substantial congruency between the subscales of a measure and its total score. The measures had variable efficiencies; the Barthel Index was the most efficient and therefore required the fewest subjects to identify a significant effect. These data suggest that careful consideration must be given to the choice of stroke outcome measures in terms of their numbers, interrelationships, and statistical properties, as these factors have important implications for the design, analysis, and conduct of clinical stroke studies. (Stroke 1990:21:731-739)

Validation of a Standardized Assessment of Postural Control in Stroke Patients

“…1 Content validity, ie, the extent to which the sampling of items reflects the aim of the index, had already been widely documented in studies referring to the Fugl-Meyer scale (see Sanford et al 20 for a review). As in the study by Dettman et al 36 or that by Wood-Dauphinee et al, 19 we noted a strong correlation between PASS score and functional indexes involving equilibrium or motricity, and this is an argument for criterion validity. In the present study, the clinical postural scale (PASS) was also related to plantar foot sensitivity, muscular weakness, and hemispatial neglect, for which the relation with postural abilities is well known.…”

“…On many occasions, this scale has proved to be a valid and reliable tool, both as a whole and particularly with regard to the mobility and balance sections that assess postural abilities. 19,20 The major drawback of the Fugl-Meyer scale is that most items (including mobility and balance items) have only 3 levels of assessment, so that many hemiplegic patients score the intermediate level and remain at this stage for quite a long time. For this reason, Lindmark and colleagues proposed a revised version of the Fugl-Meyer assessment.…”

Muscle strength is a determinant of bone mineral content in the hemiparetic upper extremity: Implications for stroke rehabilitation

“…A score from 0 to 2 was given to each task, with a higher score indicating better performance (maximum score=66). It is a reliable and valid measure of multijoint upper extremity function in stroke [29][30][31].…”

Does Acupuncture Have Additional Value to Standard Poststroke Motor Rehabilitation?

“…FMA 18 is a well-validated instrument assessing motor recovery after stroke, [22][23][24] and has been widely used for both clinical and research purposes. 25,26 FMA is a 3-point ordinal scale and has a maximum score of 226 points in 5 subsections, namely the motor (100 points), balance (14 points), range-of-movement (44 points), sensation (24 points), and pain (44 points) subsections.…”