Combined Effects of Botulinum Toxin Therapy and Splint Therapy on Upper Limb Spasticity in Chronic Stroke Patients: A Pilot Randomized Controlled Trial

BackgroundCurrent guidelines recommend combining botulinum toxin type A (BoNT-A) with adjunctive therapies for upper limb spasticity management, but evidence for individualized splinting remains limited and inconsistent. ObjectiveThis pilot randomized controlled trial investigated whether adding individualized splint therapy to BoNT-A enhances therapeutic outcomes compared to BoNT-A alone in chronic stroke patients with upper limb spasticity. MethodsTwenty-six chronic stroke patients with upper limb spasticity were randomized to receive either BoNT-A plus custom-made thermoplastic splint therapy (n=13) or BoNT-A alone (n=13). Both groups received standardized self-training instructions. Primary outcomes were passive range of motion (ROM) for wrist dorsiflexion and middle finger extension. Secondary outcomes included Modified Ashworth Scale (MAS) scores and Disability Assessment Scale (DAS) scores. Assessments were conducted at six time points over 3 months using mixed-effects models for analysis. ResultsBoth groups demonstrated substantial improvements in wrist dorsiflexion ROM (partial 2 = 0.455) and middle finger extension ROM (partial 2 = 0.306), significant reductions in MAS scores and improvements in DAS scores. No significant group effects or group x time interactions were observed for ROM, MAS, or DAS measures, indicating equivalent treatment responses. ConclusionsAdding individualized splint therapy to BoNT-A did not provide significant additional benefits for managing upper limb spasticity in chronic stroke patients. Both treatment approaches achieved similar improvements in plasticity and functional outcomes. These findings suggest that for patients who can engage in regular self-training, the addition of a static splint may not offer significant clinical advantages over a 3-month period.