Klemens Fheodoroff

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

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 patients 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

Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice

Objectives This article provides an overview of the Upper Limb International Spasticity (ULIS) programme, which aims to develop a common core dataset for evaluation of real-life practice and outcomes in the treatment of upper-limb spasticity with botulinum toxin A (BoNT-A). Here we present the study protocol for ULIS-II, a large, international cohort study, to describe the rationale and steps to ensure the validity of goal attainment scaling (GAS) as the primary outcome measure. Methods and analysis design An international, multicentre, observational, prospective, before-and-after study, conducted at 84 centres in 22 countries across three continents. Participants 468 adults presenting with poststroke upper limb spasticity in whom a decision had already been made to inject BoNT-A (5–12 consecutive participants recruited per centre). Interventions Physicians were free to choose targeted muscles, BoNT-A preparation, injected doses/technique and timing of follow-up in accordance with their usual practice and the goals for treatment. Primary outcome measure: GAS. Secondary outcomes: Measurements of spasticity, standardised outcome measures and global benefits. Steps to ensure validity included: (1) targeted training of all investigators in the use of GAS; (2) within-study validation of goal statements and (3) establishment of an electronic case report form with an in-built tracking facility for separation of baseline/follow-up data. Analysis Efficacy population: all participants who had (1) BoNT-A injection and (2) subsequent assessment of GAS. Primary efficacy variable: percentage (95% CI) achievement of the primary goal from GAS following one BoNT-A injection cycle. Ethics and dissemination This non-interventional study is conducted in compliance with guidelines for good pharmacoepidemiology practices. Appropriate ethical approvals were obtained according to local regulations. ULIS-II will provide important information regarding treatment and outcomes from BoNT-A in real-life upper limb spasticity management. The results will be published separately. Registration ClinicalTrials.gov identifier: NCT01020500.

Common goal areas in the treatment of upper limb spasticity: a multicentre analysis

Objective: 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. Design: 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. Results: 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. Conclusions: Goals for management of upper limb spasticity, in worldwide clinical practice, fall into six main goal areas.

How Can We Improve Current Practice in Spastic Paresis

1. Department of Neurorehabilitation Gailtal-Klinik, Hermagor, Austria; 2. Serviço de Reabilitação de Adultos 3, Centro de Medicina de Reabilitação de Alcoitão, Estoril, Portugal; 3. Radboud University Medical Centre, Nijmegen, and Sint Maartenskliniek Rehabilitation Centre, Nijmegen, The Netherlands; 4. Hospital Valduce, Villa Beretta, Costa Masnaga, Italy; 5. National Institute of Neurology and Neurosurgery M.V.S., Mexico City, Mexico; 6. Hôpitaux Universitaires Henri Mondor, Université Paris-Est, Créteil, France; 7. Royal and Pontifical University of Santo Tomas, Manila, Philippines

Factors influencing goal attainment in patients with post-stroke upper limb spasticity following treatment with botulinum toxin A in real-life clinical practice: sub-analyses from the Upper Limb International Spasticity (ULIS)-II Study.

In this post-hoc analysis of the ULIS-II study, we investigated factors influencing person-centred goal setting and achievement following botulinum toxin-A (BoNT-A) treatment in 456 adults with post-stroke upper limb spasticity (ULS). Patients with primary goals categorised as passive function had greater motor impairment (p < 0.001), contractures (soft tissue shortening [STS]) (p = 0.006) and spasticity (p = 0.02) than those setting other goal types. Patients with goals categorised as active function had less motor impairment (0.0001), contracture (p < 0.0001), spasticity (p < 0.001) and shorter time since stroke (p = 0.001). Patients setting goals for pain were older (p = 0.01) with more contractures (p = 0.008). The proportion of patients achieving their primary goal was not impacted by timing of first-ever BoNT-A injection (medium-term (≤1 year) vs. longer-term (>1 year)) post-stroke (80.0% vs. 79.2%) or presence or absence of severe contractures (76.7% vs. 80.6%), although goal types differed. Earlier BoNT-A intervention was associated with greater achievement of active function goals. Severe contractures impacted negatively on goal achievement except in pain and passive function. Goal setting by patients with ULS is influenced by impairment severity, age and time since stroke. Our findings resonate with clinical experience and may assist patients and clinicians in selecting realistic, achievable goals for treatment.

Poster 52: Botulinum Toxin A in Upper Limb Spasticity Management: Baseline Data from the Upper Limb International Spasticity (ULIS)-III Study

worst pain, respectively. Between-group differences were significant in actual and least pain (P < .05). Significant treatment effect in favor of ITB was observed in EQ-5D utility score: mean change was 0.09 (0.26) for ITB compared to 0.01 (0.16) for CMM (P < .05). EQ-5D health status score increased by 9.68 (20.42) for ITB versus 4.40 (21.75) for CMM (P >.05). In total 17 (68%) ITB implanted patients reported at least one treatment-related adverse event versus 7 (20%) CMM patients. No patient discontinued ITB therapy due to a treatment-related adverse event. Conclusions: The study demonstrated superiority of ITB therapy versus conventional oral medication in decreasing muscle hypertonia in post-stroke patients with spasticity. This is associated with improvements in pain and quality of life in ITB patients. Level of Evidence: Level I

Poster 57: Time to Retreatment with Botulinum Toxin A in Upper Limb Spasticity Management: Initial Data from the Upper Limb International Spasticity (ULIS)-III Study: 2016 AAPM&R Annual Assembly Abstracts

were fall resulting in landing with head on the ground (4; two got tackled by another player, one somersaulted for goal-celebration and one collided with another player), heading the ball (2) and direct head collision with another player (1). Thoracic SCI occurred due to fall on upper back while stretching to intercept ball and SCI symptoms only arose after 20 minutes of continuous play after the impact. Lumbar SCI was due to fall on lower back after colliding with another player. The player who performed goal-celebration somersault died instantaneously. 8/9 sustained acute SCIs during game time, whereas one had chronic cervical SCI due to repeated heading of the ball. 7/8 acute cases got SCI symptoms immediately after the impact. Less than a quarter of players could have continued playing soccer after recovering from SCI. More details, including management and outcomes of the SCIs suffered by most soccer players could not be studied due to unavailability of related records. Conclusions: Soccer players sustain SCI very rarely during a game or training session. However, SCI has potential to cause career-ending and catastrophic tragedy. Further studies need to be done for detailed understanding on prevention, patterns, management and outcomes of SCI in soccer players. Level of Evidence: Level IV

Neurological Rehabilitation Poster Hall: Original ResearchPoster 57: Time to Retreatment with Botulinum Toxin A in Upper Limb Spasticity Management: Initial Data from the Upper Limb International Spasticity (ULIS)-III Study

were fall resulting in landing with head on the ground (4; two got tackled by another player, one somersaulted for goal-celebration and one collided with another player), heading the ball (2) and direct head collision with another player (1). Thoracic SCI occurred due to fall on upper back while stretching to intercept ball and SCI symptoms only arose after 20 minutes of continuous play after the impact. Lumbar SCI was due to fall on lower back after colliding with another player. The player who performed goal-celebration somersault died instantaneously. 8/9 sustained acute SCIs during game time, whereas one had chronic cervical SCI due to repeated heading of the ball. 7/8 acute cases got SCI symptoms immediately after the impact. Less than a quarter of players could have continued playing soccer after recovering from SCI. More details, including management and outcomes of the SCIs suffered by most soccer players could not be studied due to unavailability of related records. Conclusions: Soccer players sustain SCI very rarely during a game or training session. However, SCI has potential to cause career-ending and catastrophic tragedy. Further studies need to be done for detailed understanding on prevention, patterns, management and outcomes of SCI in soccer players. Level of Evidence: Level IV

Poster 57: Time to Retreatment with Botulinum Toxin A in Upper Limb Spasticity Management: Initial Data from the Upper Limb International Spasticity (ULIS)-III Study

were fall resulting in landing with head on the ground (4; two got tackled by another player, one somersaulted for goal-celebration and one collided with another player), heading the ball (2) and direct head collision with another player (1). Thoracic SCI occurred due to fall on upper back while stretching to intercept ball and SCI symptoms only arose after 20 minutes of continuous play after the impact. Lumbar SCI was due to fall on lower back after colliding with another player. The player who performed goal-celebration somersault died instantaneously. 8/9 sustained acute SCIs during game time, whereas one had chronic cervical SCI due to repeated heading of the ball. 7/8 acute cases got SCI symptoms immediately after the impact. Less than a quarter of players could have continued playing soccer after recovering from SCI. More details, including management and outcomes of the SCIs suffered by most soccer players could not be studied due to unavailability of related records. Conclusions: Soccer players sustain SCI very rarely during a game or training session. However, SCI has potential to cause career-ending and catastrophic tragedy. Further studies need to be done for detailed understanding on prevention, patterns, management and outcomes of SCI in soccer players. Level of Evidence: Level IV

An international survey of patients living with spasticity.

Abstract Purpose: To better understand patient perspectives on the life impact of spasticity. Methods: Global Internet survey (April 2014–May 2015) of 281 people living with spasticity. Results: Respondents indicated that spasticity has a broad impact on their daily-life: 72% reported impact on quality of life, 44% reported loss of independence and 44% reported depression. Most respondents (64%) were cared for by family members, of whom half had stopped working or reduced their hours. Overall, 45% reported dissatisfaction with the information provided at diagnosis; main reasons were “not enough information” (67%) and “technical terminology” (36%). Respondents had high treatment expectations; 63% expected to be free of muscle spasm, 41% to take care of themselves and 36% to return to a normal routine. However, 33% of respondents had not discussed these expectations with their physician. The most common treatments were physiotherapy (75%), botulinum neurotoxin (BoNT, 73%) and oral spasmolytics (57%). Of those treated with BoNT, 47% waited >1 year from spasticity onset to treatment. Conclusions: This survey emphasises the broad impact of spasticity and highlights unmet needs in the patient journey. Improvements with regards to communication and the therapeutic relationship would be especially welcomed by patients, and would help manage treatment expectations. Implications of Rehabilitation Spasticity has broad impact on the lives of patients and their families that extends beyond the direct physical disability. Patients with spasticity need to be well informed about their condition and treatments available and should be given the opportunity to discuss their expectations. Physicians need to be aware of the patient’s individual needs and expectations in order to better help them achieve their therapeutic goals.