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

NCT06767631 | Recruiting

• 2 other identifiers: S68672Trial number 2024-513158-32-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Spasticity; Equinovarus Foot

Keywords

Botulinum Toxins; stroke; Medial Gastrocnemius Muscle; Skeletal muscle morphology; muscle composition

Outcome Measures

Primary Outcomes (1)

• sample size calculation

  To estimate the number of subjects to calculate an appropriate sample size for assessing changes in muscle, tendon and neural properties after BoNT treatment of spastic equinovarus in first-ever stroke patients by using 3DfUS and ISA in a future observational study. To calculate standard deviation and effect sizes of outcome measures obtained with 3DfUS and ISA in these patients.

  2 years

Secondary Outcomes (28)

• muscle changes

  2 years

• neural changes

  2 years

• functional changes

  2 years

• muscle changes

  2 years

• muscle changes

  2 years

Study Arms (1)

stroke patients treated with Botulinum toxine injections for spastic equinovarus

OTHER

This study involves a single-arm, exploratory, longitudinal design focusing on first-time stroke patients with spastic equinovarus deformity. Participants will receive Botulinum Neurotoxin Type A (BoNT-A) injections targeting medial and lateral gastrocnemius muscle as well ass soleus muscle. The intervention aims to assess changes in muscle, tendon, and neural properties before and after treatment by using instrumented spasticity assessment and threedimensional freehand ultrasound

Diagnostic Test: threedimensional freehand ultrasound and instrumented spasticity assessment

Interventions

threedimensional freehand ultrasound and instrumented spasticity assessment DIAGNOSTIC_TEST

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.

stroke patients treated with Botulinum toxine injections for spastic equinovarus

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Uz Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

• Hanssen B, De Beukelaer N, Schless SH, Cenni F, Bar-On L, Peeters N, Molenaers G, Van Campenhout A, Van den Broeck C, Desloovere K. Reliability of Processing 3-D Freehand Ultrasound Data to Define Muscle Volume and Echo-intensity in Pediatric Lower Limb Muscles with Typical Development or with Spasticity. Ultrasound Med Biol. 2021 Sep;47(9):2702-2712. doi: 10.1016/j.ultrasmedbio.2021.04.028. Epub 2021 Jun 8.

  PMID: 34112554 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabienne Schillebeeckx, MD

  UZ Leuven campus Pellenberg, secretariaat fysische geneeskunde en revalidatie blok 5

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabienne Schillebeeckx, MD, PI

CONTACT

0032 - 16338714; fabienne.schillebeeckx@uzleuven.be

Fabienne Schillebeeckx, MD,PI

CONTACT

0495100300; fabienne.schillebeeckx@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 10, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)