Change from baseline to month 6* | P value† | Hodges-Lehmann estimate‡ | |||
ITB (n=31) | CMM (n=29) | ||||
Average AS score in the LE of the affected side | |||||
ITT | N | 25 | 26 | 0.0140 | −0.667 (95.1%CI −1.0000 to −0.1667) |
Mean (SD) | −0.99 (0.75) | −0.43 (0.72) | |||
Median (min, max) | −0.83 (−2.3, 0.7) | −0.25 (−2.2, 0.7) | |||
Per protocol | N | 15 | 20 | 0.0592 | −0.667 (95.1%CI −1.1667 to 0.0000) |
Mean (SD) | −1.09 (0.63) | −0.48 (0.82) | |||
Median (min, max) | −0.83 (−2.3, 0.0) | −0.42 (−2.2, 0.7) | |||
Modified ITT | N | 22 | 29 | 0.0019 | −0.667 (95.1%CI −1.1667 to −0.3333) |
Mean (SD) | −1.11 (0.68) | −0.39 (0.71) | |||
Median (min, max) | −0.92 (−2.3, 0.3) | −0.33 (−2.2, 0.7) | |||
ITT completers | N | 24 | 24 | 0.0240 | −0.667 (95.1%CI −1.0000 to −0.1667) |
Mean (SD) | −1.01 (0.75) | −0.47 (0.73) | |||
Median (min, max) | −0.83 (−2.3, 0.7) | −0.33 (−2.2, 0.7) | |||
Average AS score in the UE of the affected side | |||||
ITT | N | 25 | 26 | 0.0042 | −0.600 (95%CI−1.0000 to −0.2000) |
Mean (SD) | −0.66 (0.59) | −0.17 (0.70) | |||
Median (min, max) | −0.60 (−1.6, 0.6) | 0.00 (−2.4, 0.6) | |||
Per protocol | N | 15 | 20 | 0.0494 | −0.600 (95%CI −1.0000 to 0.0000) |
Mean (SD) | −0.64 (0.58) | −0.22 (0.78) | |||
Median (min, max) | −0.60 (−1.4, 0.6) | 0.00 (−2.4, 0.6) |
*For the ITT and modified-ITT populations, the 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.
†Wilcoxon Rank Sum test: comparison of the difference in the change of AS score from baseline to month 6 between groups.
‡Hodges-Lehmann estimate of the location shift (asymptotic method) between groups with 95.1% CI for average AS score in the LE and 95% CI for average AS score in the UE.
AS, Ashworth Scale; CMM, conventional medical management; ITB, intrathecal baclofen; ITT, intention-to-treat; LE, lower extremities; LOCF, last observation carried forward; UE, upper extremities.