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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

RecruitingNAAges 18 Years - 100 YearsAllHospices Civils de Lyon
NCT05874154 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In France, more than 110.000 patients are hospitalized for stroke per year. It is the leading cause of sudden disabilities in adults. Incidence of spastic foot is evaluated at 1 year post stroke from 18% to 56% of hemiplegic patients. Spasticity, defined as an increase in the velocity-dependent response to muscle stretch measured at rest, is part of the upper motor neuron syndrome and is characterized by an increase in tonic stretch reflex. It has been proposed that upper motor neuro syndrome may induce not only spasticity but also other types of muscles overactivity such as spastic dystonia, co-contraction and clonus. In hemiplegic patients, lower limb spasticity within the posterior part of the leg frequently results in equino-varus foot and toes claw. These abnormal postures in hemiplegics may affect activities of daily living such as shoes fitting, balance, ambulation-walking, comfor

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📋 Eligibility rules (as published)
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
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What it tests

  • Tibial nerve selective neurotomy
  • Botulinum toxin injection
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Where

4 sites
Hôpital Pierre Wertheimer
Bron, France
AP-HP
Clichy, France
CHU de Nantes
Nantes, France
Hôpital Henry Gabrielle
Saint-Genis-Laval, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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