Jovita Balcaitiene

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.

Effect of early use of AbobotulinumtoxinA after stroke on spasticity progression: Protocol for a randomised controlled pilot study in adult subjects with moderate to severe upper limb spasticity (ONTIME pilot)

Introduction Approximately 15 million people suffer a stroke annually, up to 40% of which may develop spasticity, which can result in impaired limb function, pain and associated involuntary movements affecting motor control. Robust clinical data on spasticity progression, associated symptoms development and functional impairment is scarce. Additionally, maximal duration of muscle tone reduction following botulinum toxin type A (BoNT-A) injections remains undetermined. The ONTIME pilot study aims to explore these issues and evaluate whether abobotulinumtoxinA 500 U (Dysport®; Ipsen) administered intramuscularly within 12 weeks following stroke delays the appearance or progression of symptomatic (disabling) upper limb spasticity (ULS). Methods ONTIME is a 28-week, phase 4, randomised, double-blind, placebo-controlled, exploratory pilot study initiated at four centres across Malaysia, the Philippines, Singapore and Thailand. Subjects (n = 42) with moderate to severe ULS (modified Ashworth scale [MAS] score ≥2) in elbow flexors or pronators, wrist flexors, or finger flexors will be recruited. Subjects will be randomised 2:1 to abobotulinumtoxinA 500 U or placebo (single dose 2–12 weeks after first-ever stroke). Primary efficacy will be measured by time between initial injection and visit at which reinjection criteria (MAS score ≥2 in the primary targeted muscle group and appearance or reappearance of symptomatic ULS) are met. Follow-up visits will be 4-weekly to a maximum of 28 weeks. Discussion This pilot study will facilitate the design and sample size calculation of further confirmatory studies, and is expected to provide insights into the optimal management of post-stroke patients, including timing of BoNT-A therapy and follow-up duration.

Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study

The ONTIME study investigated whether early post-stroke abobotulinumtoxinA injection delays appearance or progression of upper limb spasticity (ULS) symptoms. ONTIME (NCT02321436) was a 28-week, exploratory, double-blind, randomized, placebo-controlled study of abobotulinumtoxinA 500U in patients with ULS (Modified Ashworth Scale [MAS] score ≥ 2) 2–12 weeks post-stroke. Patients were either symptomatic or asymptomatic (only increased MAS) at baseline. Primary efficacy outcome measure: time between injection and visit at which re-injection criteria were met (MAS ≥ 2 and ≥1, sign of symptomatic spasticity: pain, involuntary movements, impaired active or passive function). Forty-two patients were randomized (abobotulinumtoxinA 500U: n = 28; placebo: n = 14) with median 5.86 weeks since stroke. Median time to reach re-injection criteria was significantly longer for abobotulinumtoxinA (156 days) than placebo (32 days; log-rank: p = 0.0176; Wilcoxon: p = 0.0480). Eleven (39.3%) patients receiving abobotulinumtoxinA did not require re-injection for ≥28 weeks versus two (14.3%) in placebo group. In this exploratory study, early abobotulinumtoxinA treatment significantly delayed time to reach re-injection criteria compared with placebo in patients with post-stroke ULS. These findings suggest an optimal time for post-stroke spasticity management and help determine the design and sample sizes for larger confirmatory studies.

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

Poster 62: Effect on Voluntary Movements of Simultaneous Upper and Lower Limb AbobotulinumtoxinA Injections in Conjunction with Guided Self-Rehabilitation Contracts in Adults with Spastic Hemiparesis: Methodology of the ENGAGE Study

(76%). In bivariate analysis, disposition was associated with initial NIHSS (P<.05) but not age, sex, or race. In multivariate analysis, only initial NIHSS was associated with disposition. Conclusions: Patients with a NIHSS>4 are more likely to be discharged to a rehabilitation facility. Early PM&R consultation for patients with a NIHSS score>4 may enable patients who are candidates for acute rehabilitation to enter rehabilitation at the most appropriate facility at the correct timing. Level of Evidence: Level III

Poster 64: AbobotulinumtoxinA Injections in the Upper and Lower Limb in Patients with Spastic Paresis and Impaired Function Following Stroke or Traumatic Brain Injury

(76%). In bivariate analysis, disposition was associated with initial NIHSS (P<.05) but not age, sex, or race. In multivariate analysis, only initial NIHSS was associated with disposition. Conclusions: Patients with a NIHSS>4 are more likely to be discharged to a rehabilitation facility. Early PM&R consultation for patients with a NIHSS score>4 may enable patients who are candidates for acute rehabilitation to enter rehabilitation at the most appropriate facility at the correct timing. Level of Evidence: Level III

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.