RecruitingNot ApplicableNCT06767631

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

Exploratory, Longitudinal Study to Define Changes in Muscle, Tendon and Neural Properties After Botuline Neurotoxin Type A (BoNT) Treatment of Spastic Equinovarus in First-ever Stroke Patients: a Pilot Study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

12 participants

Start Date

May 2, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke Spasticity Equinovarus Foot

Summary

Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Treatment outcomes and long-term responses to interventions can vary significantly between individual patients. Additionally, there is increasing concern about potential adverse effects on muscle morphology. Further research is essential to optimize treatment strategies and improve long-term outcomes in this population. Three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) are two recently developed techniques that enable the evaluation of changes in muscle, tendon, and neural properties following BoNT injections for post-stroke spastic equinovarus. These methods hold promise for providing new insights into treatment effects. Before implementing these techniques in large-scale studies, a pilot study is required for accurate sample size calculations for a prospective observational study. This study includes a protocol for a non-blinded, non-randomized open-label longitudinal pilot study. The study was approved by the European Medicines Agency ( EU CT Number 2024-513158-32) by the University Hospitals Leuven ethical committee (ID S68672). Standard deviations and effect sizes of outcome measures obtained longitudinally with 3DfUS and ISA before and after BoNT injection into MG will inform sample size calculations for future research.

Eligibility

Min Age: 40 YearsMax Age: 60 Years

Inclusion Criteria7

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
\. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
\. Pes equinovarus due to spasticity
\. Clinical need for BoNT injection at the lower leg
\. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago
\. First-ever, unilateral stroke

Exclusion Criteria9

Musculoskeletal or other neurological problems affecting the lower limb
Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
Cognitive problems that impede measurements
Severe co-morbidities
Irritated skin or open wounds where ultrasound will be placed
Pregnancy
Profound atrophy of the muscles in the target area(s) of injection
Participation in an interventional Trial with an investigational medicinal product (IMP) or device
The effect of botulinum toxin A can theoretically be potentiated by agents affecting neuromuscular transmission, such as aminoglycoside antibiotics (e.g., gentamicin, tobramycin), lithium salts, cholinesterase inhibitors and tubocurarine-like muscle relaxants ((cis)atracurium, rocuronium, suxamethonium, vecuronium). Therefore, patients on whom these medications are started during the course of the trail will be excluded.

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Interventions

DIAGNOSTIC_TESTthreedimensional freehand ultrasound and instrumented spasticity assessment

To conduct a pilot study as guidance for a future observational study to evaluate changes in muscle, tendon and neural properties after botulinum neurotoxin-A (BoNT) treatment of spastic equinovarus in first-ever stroke patients by using Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA) with the aim of optimizing treatment algorithms and long-term response in this population.