Pilot Study on Muscle, Tendon, and Nerve Changes After Botulinum Neurotoxin-A Treatment for Spastic Equinovarus in First-Time Stroke Patients

What this Trial Is About

Researchers are studying post-stroke spasticity, focusing on the common complication called pes equinovarus, which greatly impairs movement. Botulinum toxin A BoNT injections into the medial gastrocnemius muscle are a common treatment, but patient responses can vary widely. This pilot study aims to better understand how muscle, tendon, and nerve properties change after BoNT treatment using advanced techniques. The study is designed to guide future larger observational research by providing essential data for sample size calculations. The study uses a single group of first-time stroke patients with spastic equinovarus who will receive BoNT injections into the medial and lateral gastrocnemius muscles as well as the soleus muscle. Researchers will assess changes in these muscles before and after treatment using Three Dimensional freehand Ultrasound 3DfUS and Instrumented Spasticity Assessment ISA. Four visits are planned a baseline at week 0, an injection visit at weeks 5-7, a follow-up at weeks 10-12, and an end-of-study visit between weeks 18 and 30, aligned with the expected timing of BoNT effects. Participants will undergo measurements of muscle and neural properties at each visit on both legs, focusing on the medial gastrocnemius and tibialis anterior muscles. A pregnancy test is done before BoNT injection to ensure safety. Each visit lasts about 1.5 to 2 hours and includes ultrasound and spasticity assessments. The study measures changes over time to inform future research and improve treatment strategies. All visits and assessments take place at the University Hospital Leuven, with careful monitoring of functional, muscular, and neural changes throughout the study period.

Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus