Disclosures: Alberto Esquenazi, MD: Allergan (Products/Services: Yes) (Consultant/Advisory Board, Research Grant or Support, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received)

Objective: 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: Ongoing prospective, international, longitudinal real-life clinical observational study. Setting : International, multicenter study at specialist sites. Participants : Eligible participants are aged ≥18 years with unilateral adult lower limb 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.

Interventions: Participants are treated as per routine practice 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.

Main Outcome Measures: The primary endpoint is goal attainment as assessed using the cumulated GAS-leg T score, across all cycles for each subject. 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.

Results: Recruitment began November 1st 2019 and is expected to complete in Q1 2022. 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.

Level of Evidence: Level II

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/an-international-multicenter-observational-longitudinal-study-to-assess-the-effectiveness-of-abobotulinumtoxina-injections-for-adult-lower-limb-spasticity-the-abolish-study/