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

To document the current practice in relation with the treatment of patients with upper limb spasticity with botulinum toxin type A to inform future research in this area. We designed an international, cross-sectional, noninterventional survey of current practice. Nine hundred and seventy-four patients from 122 investigational centres in 31 countries were studied. Most patients were over 40 years old and had a stroke. Improvement of active function was the most frequent treatment goal in the first 3 months after the onset of upper limb spasticity, but was less common than passive function in the chronic stage. Pain relief was a common goal in both the stages. As a rule, clinicians intended to assess the effectiveness of treatment with impairment level scales. Functional outcome measures seem to be rarely used in clinical practice. The use of these measures should be encouraged to assess whether the reduction in muscle tone translates into functional benefit to patients and their caregivers.

We aimed to develop a goal classification of individualised goals for spasticity treatment incorporating botulinum toxin intervention for upper limb spasticity to under-pin a more structured approach to future goal setting. Individualised goals for spasticity treatment incorporating botulinum toxin intervention for upper limb spasticity (n=696) were analysed initially from four studies published in 2008-2012, spanning a total of 18 centres (12 in the UK and 6 in Australia). Goals were categorised and mapped onto the closest matching domains of the WHO International Classification of Functioning. Confirmatory analysis included a further 927 goals from a large international cohort study spanning 22 countries published in 2013. Goal categories could be assigned into two domains, each subdivided into three key goal areas: Domain 1: symptoms/impairment n=322 (46%): a. pain/discomfort n=78 (11%), b. involuntary movements n=75 (11%), c. range of movement/contracture prevention n=162 (23%). Domain 2: Activities/function n=374 (54%): a. passive function (ease of caring for the affected limb) n=242 (35%), b active function (using the affected limb in active tasks) n=84 (12%), c. mobility n=11 (2%). Over 99% of the goals from the large international cohort fell into the same six areas, confirming the international applicability of the classification. Goals for management of upper limb spasticity, in worldwide clinical practice, fall into six main goal areas.

Off-the-shelf orthoses used in rehabilitation medicine present challenges in the lack of individual comfort offered and in the support of the different motor conditions of the affected individuals. Although custom-made orthoses address these issues, their current fabrication method consists of a laborious and material wasteful process performed by skilled orthotists. Combining 3D scanning, 3D modelling and 3D printing, this paper proposes and assesses a method for the fabrication of custom-made products for rehabilitation medicine. In collaboration with CMRA, a Hospital dedicated to rehabilitation, the method is applied to the design of a customised knee positioning orthosis for a patient with cerebral palsy. This project is exploratory on the capabilities of the use of 3D printing in patient specific customisation of orthoses. Having developed, prototyped and tested four different concepts with the patient, from which one was successfully accepted, it is possible to demonstrate the potential of industrialisation of these technologies.