alexa Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management.


International Journal of Neurorehabilitation

Author(s): TurnerStokes L, Fheodoroff K, Jacinto J, Maisonobe P

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Abstract OBJECTIVE: To describe real-life practice and person-centred outcomes in the treatment of poststroke upper limb spasticity with botulinum toxin A (BoNT-A). DESIGN: Observational, prospective study. SETTING: 84 secondary care centres in 22 countries. PARTICIPANTS: 456 adults (≥18 years) with poststroke upper limb spasticity treated with one cycle of BoNT-A. METHODS/OUTCOMES: Muscle selection, BoNT-A preparation, injection technique and timing of follow-up were conducted according to routine practice for each centre. PRIMARY OUTCOME: achievement of the patient's primary goal for treatment using goal-attainment scaling (GAS). Measurements of spasticity, standardised outcome measures and global benefits were also recorded. RESULTS: The median number of injected muscles was 5 (range 1-15) and the most frequently injected muscles were the long finger flexors, followed by biceps and brachioradialis. The median (range) follow-up time was 14 (2.6 to 32.3) weeks. The common primary treatment goals were passive function (132 (28.9\%)), active function (104 (22.8\%)), pain (61 (13.4\%)), impairment (105 (23\%)), involuntary movement (41 (9\%)) and mobility (10 (2.2\%)). Overall, 363 (79.6\%) (95\% CI 75.6\% to 83.2\%) patients achieved (or overachieved) their primary goal and 355 (75.4\%) (95\% CI 71.2\% to 79.2\%) achieved their secondary goal. Mean (SD) change from baseline in GAS T-scores was 17.6 (11.0) (95\% CI 16.4 to 18.8; p<0.001). GAS T-scores were strongly correlated with global benefit and other standard measures (correlations of 0.38 and 0.63, respectively; p<0.001). CONCLUSIONS: BoNT-A demonstrated a clinically significant effect on goal attainment for the real-life management of upper-limb spasticity following stroke. The study confirms the feasibility of a common international data set to collect systematic prospective data, and of using GAS to capture person-centred outcomes relating to passive and active functions and to pain. REGISTRATION: identifier: NCT01020500.
This article was published in BMJ Open and referenced in International Journal of Neurorehabilitation

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