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

Last updated: March 11, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Limb Spasticity

Treatment

Tibial nerve selective neurotomy

Botulinum toxin injection

Clinical Study ID

NCT05874154
69HCL22_0905
  • Ages 18-100
  • All Genders

Study Summary

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, comfort (pain) and may become irreducible (tendon shortening) if not treated.

The purpose of this study is to compare the interest of each treatment (BoNT-A versus STN) in order to specify both techniques indications and up-date current guidelines of lower-limb spasticity for hemiplegic patients.

This study aims to confirm a greater reduction of calf muscles spasticity after STN as compared to BoNT-A, as observed in the only published monocentric randomized controlled trial. Our study originality is to perform a multi-center RCT with a pre-established sample size. This study will also quantify progress towards personal goals using the goal attainment scaling (GAS) and will assess other components related to the consequences of carve muscle spasticity on balance, ambulation, self-care and quality of life.

Eligibility Criteria

Inclusion

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 thetriceps surae and /or one of the following muscles: tibialis posterior, flexordigitorum and hallucis longus muscles.

  • Spasticity confirmed with no isolated tendon shortening diagnosed using tibialisnerve block under local anesthesia with at least a 5 degrees gain in passive oractive 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 ortrusted person of the patient

Exclusion

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 investigatoror supported by a family member

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Tibial nerve selective neurotomy
Phase:
Study Start date:
January 02, 2024
Estimated Completion Date:
June 02, 2026

Connect with a study center

  • Hôpital Pierre Wertheimer

    Bron, 69394
    France

    Site Not Available

  • AP-HP

    Clichy, 92110
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • Hôpital Henry Gabrielle

    Saint-Genis-Laval, 69230
    France

    Active - Recruiting

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