Objectives: To assess the longitudinal attainment of person-centered and function-related goals after one or more abobotulinumtoxinA injections in the lower limb over 16 months in a real-life clinical setting.
Design: The ABOLiSH study is a prospective, international, longitudinal real-life clinical observational study. Eligible participants are aged ≥18 years with unilateral adult lower limb nonprogressive spasticity, able to take ≥5 steps with or without assistance, and for whom the decision has already been made to inject abobotulinumtoxinA in accordance with local prescribing guidelines (maximum dose 1500U). Participants can be naive to botulinum toxin or previously treated and injection parameters will be documented at every visit where abobotulinumtoxinA is injected (including technique, injection intervals and rehabilitation interventions). At baseline, and all subsequent treatment cycles, participants (±caregiver) in consultation with the care provider will choose one primary goal and up to two secondary goals related to lower limb spasticity using SMART criteria. Adjustments in goal selection are permitted in different treatment cycles. Goal attainment will be assessed at a relevant time (determined by the investigator) within each injection cycle.
Results: The primary endpoint is
goal attainment as assessed using GAS-leg T score, for all cycles per subject (in predefined goal categories at every visit, from Visit 1 to study end). Correlations of patient-centered goals and related standardized rating scales will be assessed. Investigator and participant satisfaction with treatment (Global Assessment of Benefit) and quality of life will also be assessed.
Conclusions: Given the diversity of spasticity clinical presentation in practice, treatment management plans, trajectory of response post treatment and goals selected, it is important to collect longitudinal data to measure progression in treatment outcomes (specifically goal attainment) and evaluate the key factors influencing decision making for adult lower-limb spasticity management and the development of appropriate educational interventions to address the findings.
Alberto Esquenazi– Chief Medical Officer, MossRehab Gait and Motion Analysis Laboratory
Stephen Ashford– Senior Clinical Lecturer and Consultant Physiotherapist, King’s College London
Allison Brashear– Dean, University of California Davis School of Medicine
Pascal Maisonobe– Director of Biometrics, Ipsen Bioscience
Andreas Lysandropoulos– Medical Advisor, Ipsen Pharma