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Results from the Upper Limb International Spasticity Study-II (ULIS-II): a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management
  1. Lynne Turner-Stokes1,
  2. Klemens Fheodoroff2,
  3. Jorge Jacinto3,
  4. Pascal Maisonobe4
  1. 1Department of Palliative Care, Policy and Rehabilitation, School of Medicine, King's College London, London, UK
  2. 2Neurorehabilitation, Gailtal-Klinik, Hermagor, Austria
  3. 3Centro de Medicina de Reabilitaçãode Alcoitão, Serviço de Reabilitação de adultos 3, Estoril, Portugal
  4. 4Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France
  1. Correspondence to Professor Lynne Turner-Stokes; lynne.turner-stokes{at}dial.pipex.com

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 ClinicalTrials.gov identifier: NCT01020500

  • botulinum toxin A
  • goal attainment scaling
  • post-stroke spasticity
  • stroke rehabilitation

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