Clinical presentation of patients with lower limb spasticity undergoing routine treatment with botulinum toxin: baseline findings from an international observational study

Objective: Describe how people with lower limb spasticity present for treatment in routine clinical practice. Methods: Prospective, observational study (Clinicaltrials.gov: NCT04050527) of ambulatory adult patients (>= 18 years) with unilateral lower limb spasticity (able to take >= 5 steps with or without assistance) presenting for routine spasticity management, including treatment with abobotulinumtoxinA. Results: The study population included 430 adults with lower limb spasticity. Despite their relatively young age (mean +/- standard deviation 53.7 +/- 13.9 years), only 20% of patients were employed. Most patients had an acquired brain injury due to cerebrovascular disease; 84.1% reported having concomitant upper limb spasticity. Using the Leg Activity Measure, most patients reported no or only mild difficulties in performing hygiene/positioning tasks, while 80.7% had at least mild difficulty with indoor ambulation and 90.5% had at least mild difficulty with walking outdoors. Sensory, communication and/or cognitive impairments were also common. At the first treatment cycle, 50.7% of patients set active function primary goals, including locomotion transferring or standing. Conclusion: These observations highlight the complexity of presentation that must be considered when setting treatment goals for lower limb spasticity and emphasize the types of impairment and activity (functional) limitations that treating teams may expect to encounter in their patients and should cover in their initial and follow-up assessments.