Botuloscope: 1-year follow-up of upper limb post-stroke spasticity treated with botulinum toxin

Background: Botuloscope is a cohort study supported by a French public grant and aiming to evaluate a 1-year treatment of the post-stroke spastic upper limb with botulinum toxin type A (BoNT-A) in terms of individual satisfaction with respect to personalized goals and quality of life.

Methods: This was an open-label prospective, multicentric study (11 French centres) that followed 330 adults [mean (SD) age 53.7 (13.7) years] over 1 year; participants had ranked 5 therapeutic goals at inclusion [mean (SD) 5.1 (7.3) years post-stroke], had severe hemiparesis [median motricity index (MI) 40 (Q1-Q3 24 to 60)], and were assessed at inclusion (M0) and at month 3 (M3) and M12. Outcome criteria were: spasticity, range of motion, pain [visual analog scale (VAS)], motor function [Modified Ashworth Scale (MAS)] and activities (MI; Frenchay Arm Test), and overall satisfaction with the achievement of each goal (VAS) and quality of life (Reintegration to Normal Life Index). Criteria at M0 and M12 were compared. Adverse effects were also collected, as were medication changes.

Results: The primary goal was comfort and activities for 63% of participants and motor function for 36%. Participants underwent a mean of 2.4 injection sessions, 19% causing adverse effects. The greatest spasticity attenuation occurred with wrist flexors (median decrease in MAS -2 [Q1-Q3; -2 to -1], P<10^-3). Fewer individuals took oral anti-spastic drugs (56% at M12 vs 50% at M0; P<10^-2). Range of motion increased by 16°, on average (13 to 19; P<10^-3) for wrist extension. Pain prevalence decreases at rest (29% at M0 vs. 19% at M12; P<10^-4) and during mobilization (64% vs. 43%; P<10^-4), and fewer participants took analgesics (25% vs. 17%; P<10^-3). Satisfaction was high for the goals "hand hygiene" and "pain release" and moderate for "improvement in upper limb function". However, function was more improved for participants who selected this goal as the first priority than others (P<10^-2). Overall, 22% had the goal "improving gait and balance", which was reasonably achieved at M12. Quality of life improved markedly [median 8 (4 to 11) vs. 6 (3 to 10); P<10^-4]. Prevalence of complete dissatisfaction with the first objective was 10% to 15%.

Conclusion: This is the first long-term follow-up of BoNT-A treatment for upper limb spasticity involving a large cohort independent of industry. Quality of life was improved by treating upper limb spasticity with BoNT-A, even at 5 years post-stroke. Personalizing objectives of the treatment amplified its efficacy. BoNT-A was a powerful analgesic when pain was spasticity-related. Treating the spastic upper limb also improved balance and gait abilities.