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NCT05874154 | RECRUITING | Post Stroke Seizure

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
Sponsor:

Lyon Civilian Hospices

Brief 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.

Condition or disease

Post Stroke Seizure

Spastic Foot

Intervention/treatment

Tibial nerve selective neurotomy

Botulinum toxin injection

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : 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
Actual Study Start Date : 2024-01-02
Estimated Primary Completion Date : 2026-06-02
Estimated Study Completion Date : 2026-06-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
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

Location Details

NCT05874154

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

France,

Pierre Wertheimer Hospital

Bron, France, 69394

NOT YET RECRUITING

France,

AP-HP

Clichy, France, 92110

NOT YET RECRUITING

France,

Nantes of Chu

Nantes, France, 44093

RECRUITING

France,

Henry Gabrielle Hospital

Saint-Genis-Laval, France, 69230