Evaluation of Tibial Nerve Selective Neurotomy Compared to Botulinum Toxin Injections for Spastic Foot Treatment in Post-stroke Patients According to a Goal-centered Approach

Launched by HOSPICES CIVILS DE LYON · May 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for managing spastic foot, which is a common issue for patients who have had a stroke. Spastic foot happens when the muscles in the leg become stiff or rigid, making it difficult to walk and perform daily activities. The trial will compare two treatment options: **Botulinum Toxin A (BoNT-A)** injections, which help relax the muscles, and **Selective Tibial Nerve Neurotomy (STN)**, a surgical procedure that targets specific nerves to reduce muscle tightness. The goal is to see which treatment works better in improving patients' mobility and overall quality of life.

To participate in the trial, individuals must be adults over 18 years old who have had a stroke and experience spastic foot. They should have noticeable muscle tightness in their legs but not severe tendon shortening. Participants will be able to share their personal goals for treatment, and the study will measure how well each method helps them achieve those goals. The trial is currently recruiting participants and is open to both men and women. It's important for potential participants to understand the purpose of the study and to provide consent, either personally or through a trusted family member. This research aims to improve treatment guidelines for spastic foot in stroke patients, which can lead to better care and outcomes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients (older than 18 years)
• • Man and woman
• • Hemiparesis secondary to stroke (delay from stroke \> 1 year)
• • Foot with equinovarus with or without toe claw due to spasticity of at least the triceps surae and /or one of the following muscles: tibialis posterior, flexor digitorum and hallucis longus muscles.
• • Spasticity confirmed with no isolated tendon shortening diagnosed using tibialis nerve block under local anesthesia with at least a 5 degrees gain in passive or active ankle dorsal flexion.
• • Covered by National French insurance
• • Able to understand French and the purpose of the study
• • Informed consent signed by the patient or consent obtained from a relative or trusted person of the patient
• Exclusion Criteria:
• • Known sensitivity to BoNT or botulinum toxin A excipients
• • Contraindication to surgery under general anesthesia
• • History of myasthenia
• • Pregnant woman (confirmed by urinary test) or breastfeeding
• • Patient under legal protection
• • Patients unable to follow the requirement of the study according to the investigator or supported by a family member