FIM total score and FIM motor and cognition subscores (ITT population)
| FIM total | FIM motor subscore | FIM cognition subscore | |||||
| ITB | CMM | ITB | CMM | ITB | CMM | ||
| Baseline | N | 31 | 29 | 31 | 29 | 31 | 29 |
| Mean (SD) | 89.23 (28.76) | 96.10 (19.45) | 59.77 (24.96) | 66.45 (14.96) | 29.45 (7.66) | 29.66 (7.41) | |
| Median (min, max) | 101.00 (25.0, 126.0) | 103.00 (47.0, 124.0) | 72.00 (13.0, 91.0) | 71.00 (41.0, 89.0) | 34.00 (11.0, 35.0) | 33.00 (6.0, 35.0) | |
| Change from baseline to month 6* | N | 25 | 26 | 25 | 26 | 25 | 26 |
| Mean (SD) | 2.68 (10.31) | −2.58 (11.00) | 2.20 (8.90) | −0.96 (8.14) | 0.48 (3.92) | −1.62 (4.92) | |
| Median (min, max) | 0.00 (−21.0, 27.0) | −2.00 (−26.0, 33.0) | 0.00 (−21.0, 22.0) | −3.00 (−18.0, 26.0) | 0.00 (−6.0, 15.0) | 0.00 (−15.0, 8.0) | |
| P value† | 0.0540 | 0.0964 | 0.2569 | ||||
*Calculation was based on LOCF imputation using data for month 3 assessment in patients for whom month 6 data were not available. Patients with data missing for both months 3 and 6 were excluded from the analysis.
†Comparison of the change from baseline to month 6 between groups using the Wilcoxon test.
CMM, conventional medical management; FIM, Functional Independence Measure; ITB, intrathecal baclofen; ITT, intention-to-treat; LOCF, last observation carried forward.