Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS).

Functional independence An improvement in FIM total score from baseline to month 6 occurred in the ITB arm (+2.68 (10.31)), while a worsening occurred in the CMM arm (−2.58 (11.00)) ( table 3 and figure 3 ); the analysis showed a trend towards a treatment effect in favour of ITB over CMM (P=0.0540).

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9 12 For the FIM total score, a positive trend for improvement with ITB therapy versus CMM was observed, despite the relatively short follow-up period.

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The robustness of the treatment effect was confirmed by sensitivity analyses which all showed the same magnitude of effect, although the between-group difference did not reach statistical significance in the PP population, likely due to the reduced sample size.

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