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

NCT ID: NCT05874154

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2027-03-02

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.

Conditions

Post Stroke Seizure; Spastic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tibial nerve selective neurotomy

Group Type: EXPERIMENTAL

Tibial nerve selective neurotomy

Intervention Type: PROCEDURE

Patients in the STN group will undergo a pre-anaesthetic visit before surgery to validate the possibility of general anesthesia. The surgery will be performed at maximum 3 months after inclusion. The muscles that have been defined pre-randomization will be targeted by the surgery. The duration of the surgery is about 1 hour and 30 minutes.

Botulinum toxin injection

Group Type: ACTIVE_COMPARATOR

Botulinum toxin injection

Intervention Type: DRUG

Patients in the BoNT group will be treated with BoNT A under electromyography, electrical stimulation and/or ultrasound guidance (V0). In the absence of scientific evidence between the efficacy of onabotulinumtoxin A and abobotulinumtoxin A, physician will be free to choose between these two BoNT formulation which are both authorized for the treatment of lower limb spasticity. The physician will determine the muscles targeted by the BoNT (gastrocnemius and soleus for equinus, posterior tibialis for varus, and long flexor digitorum and flexor hallucis for claw toes), the appropriate dose and dilution based on his experience, following a semi-guided table of equivalence for respective doses of onabotulinumtoxin A and abobotulinumtoxin A. A delay superior to 3 months will be respected after the last injection and the muscles that have been defined pre-randomization will be targeted by injections.

Interventions

Tibial nerve selective neurotomy

Patients in the STN group will undergo a pre-anaesthetic visit before surgery to validate the possibility of general anesthesia. The surgery will be performed at maximum 3 months after inclusion. The muscles that have been defined pre-randomization will be targeted by the surgery. The duration of the surgery is about 1 hour and 30 minutes.

Intervention Type: PROCEDURE

Botulinum toxin injection

Patients in the BoNT group will be treated with BoNT A under electromyography, electrical stimulation and/or ultrasound guidance (V0). In the absence of scientific evidence between the efficacy of onabotulinumtoxin A and abobotulinumtoxin A, physician will be free to choose between these two BoNT formulation which are both authorized for the treatment of lower limb spasticity. The physician will determine the muscles targeted by the BoNT (gastrocnemius and soleus for equinus, posterior tibialis for varus, and long flexor digitorum and flexor hallucis for claw toes), the appropriate dose and dilution based on his experience, following a semi-guided table of equivalence for respective doses of onabotulinumtoxin A and abobotulinumtoxin A. A delay superior to 3 months will be respected after the last injection and the muscles that have been defined pre-randomization will be targeted by injections.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Pierre Wertheimer

Bron, , France

Site Status: NOT_YET_RECRUITING

AP-HP

Clichy, , France

Site Status: NOT_YET_RECRUITING

CHU de Nantes

Nantes, , France

Site Status: NOT_YET_RECRUITING

Hôpital Henry Gabrielle

Saint-Genis-Laval, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jacques LUAUTE, MD,PhD

Role: CONTACT

jacques.luaute@chu-lyon.fr

04 72 35 71 69

Anne-Laure CHARLOIS

Role: CONTACT

anne-laure.charlois@chu-lyon.fr

0472355837

Facility Contacts

Patrick MERTENS, MD,PhD

Role: primary

Pjilippe ² DECQ, MD,PhD

Role: primary

Kevin BUFFENOIR, MD,PhD

Role: primary

Jacques LUAUTE, MD,PhD

Role: primary

Other Identifiers

69HCL22_0905

Identifier Type: -

Identifier Source: org_study_id