Botulinum Toxin Type A Improves Function According to Goal Attainment in Adults with Poststroke Lower Limb Spasticity...

Botulinum toxin type A (BoNT-A) is an effective and well-tolerated treatment for adult lower limb spasticity. However, data are inadequate to determine BoNT-A efficacy for active function. This study evaluated functional goal achievement (measured by goal attainment scaling [GAS]) following lower limb BoNT-A injection in clinical practice.

Phase 4, postmarketing, multicenter, prospective, observational study (NCT01444794) in adults with poststroke lower limb spasticity receiving one BoNT-A injection cycle. Assessments were at baseline (pretreatment), 1 month ±7 days (visit 1), and 3-5 months posttreatment (visit 2). Primary outcome measure was GAS; additional assessments included Modified Ashworth Scale, Demeurisse Motricity Index, 10-meter walk test, and Disability Assessment Scale.

Of 100 enrolled patients, 94 completed the study. Most common primary treatment goals at baseline were improving mobility (57.5%) and positioning (18.1%). At visit 2, 88.3% achieved their primary goal; 87.0% (n = 47/54) for mobility, and 100.0% (n = 17/17) for positioning. In total, 79.1% of patients achieved their secondary goals. Two factors were predictive of primary goal achievement: time since stroke onset (OR 0.907; 95% CI 0.827-0.995; p = 0.038); and absence of stiff knee spasticity pattern (OR 0.228; 95% CI 0.057-0.911; p = 0.036). All functional scales showed improvements; walking speed (mean [SD]) improved by 0.06 (0.13) and 0.05 (0.20) m/s at visits 1 and 2, respectively.

BoNT-A injection for lower limb spasticity led to high goal achievement rates in patient-centered GAS evaluation and functional and symptomatic improvements. BoNT-A may therefore deliver clinically meaningful functional improvements in real-life practice.