Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ULIS-III Study.

Abstract

ObjectiveTo describe the utility of a structured approach to assessing effectiveness following injection with botulinum toxin-A alongside physical therapies, within the first cycle of the Upper Limb International Spasticity-III (ULIS-III) study.MethodsULIS-III (registered at clinicaltrials.gov as NCT02454803) is a large international, observational, longitudinal study of adults treated for upper-limb spasticity. It introduces novel methods for the structured evaluation of person-centred goal attainment alongside targeted standardized outcome measures: the Upper limb Spasticity Index, and the Upper Limb Spasticity Therapy Recording Schedule.ResultsA total of 953/1,004 enrolled patients (95%) completed cycle 1. Mean overall goal attainment scaling (GAS) T scores were 49.8 (95% confidence interval 49.2–50.3; 67.1% of patients met their primary goal, with highest achievement rates for goals related to involuntary movement, (75.6%) and range of movement (74.4%). Standardized measures of spasticity, pain, involuntary movements, active and passive function, all improved significantly over the treatment cycle. Overall, 59.7% of patients saw a therapist following botulinum toxin-A injection. Interventions varied, as expected, with the set treatment goals. After controlling for concomitant therapies using the upper limb spasticity therapy recording schedule, significant differences in injection intervals (p < 0.001) were seen between the commercially-available botulinum toxin-A agents.ConclusionThe results of this study confirm the utility of the Upper Limb Spasticity Index and Upper Limb Spasticity Therapy Recording Schedule as a structured approach to capturing goal-setting, therapy inputs and outcomes assessment.LAY ABSTRACTThis paper presents the first results from the ULIS-III study, a large international study which explores real life clinical practice in the integrated management of upperlimb spasticity, using Botulinum Toxin-A (BoNT-A) in conjunction with physical therapies. ULIS-III is the first study to use the Upper Limb Spasticity Index (ULS Index), a system for assessing the benefits of treatment that combines recording how well the intended goals for treatment were achieved, alongside standardized measures to improve the comparability of outcomes. The data confirm good overall response rates. Importantly, when standardized measures are appropriately targeted on the individual’s priority treatment goals, they demonstrate clear measurable improvements in daily function. It is also the first study to use the Upper Limb Spasticity Therapy Recording Schedule (ULSTR) to systematically record and describe the physical therapies provided. It shows how this information helped us to explore differences between BoNT-A products in the time that each injection lasts before the next one is needed.