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

NCT05874154 | Recruiting

• 1 other identifier: 69HCL22_0905
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Keywords

Tibial nerve selective neurotomy; botulinum toxin; spastic foot; post-stroke patient

Outcome Measures

Primary Outcomes (1)

• Evolution of the value of Goal Attainment Scaling

  Primary endpoint will be assessed using the Goal Attainment Scaling before treatment and the evaluation at the endpoint. Goals are defined before initiation of treatment, and attainment at study end is scored using a 5-point scale (-2, -1, 0, 1, 2); -2: pretreatment level, -1: less than expected; 0: expected goal; +1: somewhat more than expected; +2: best possible outcome expected

  through study completion, 14 months

Secondary Outcomes (10)

• Evolution of Functional outcomes

  through study completion, 14 months

• Tardieu's scale

  through study completion, 14 months

• Modified Ashworth scale

  through study completion, 14 months

• Evolution of ankle motion range

  through study completion, 14 months

• Proportion of patients with antispastic drug

  through study completion, 14 months

Study Arms (2)

Tibial nerve selective neurotomy

EXPERIMENTAL

Procedure: Tibial nerve selective neurotomy

Botulinum toxin injection

ACTIVE COMPARATOR

Drug: Botulinum toxin injection

Interventions

Tibial nerve selective neurotomy 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.

Tibial nerve selective neurotomy

Botulinum toxin injection 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.

Botulinum toxin injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

Hôpital Pierre Wertheimer

Bron, 69394, France

NOT YET RECRUITING

AP-HP

Clichy, 92110, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44093, France

NOT YET RECRUITING

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Jacques LUAUTE, MD,PhD

CONTACT

04 72 35 71 69; jacques.luaute@chu-lyon.fr

Anne-Laure CHARLOIS

CONTACT

0472355837; anne-laure.charlois@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 24, 2023
• Study Start: January 2, 2024
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): March 2, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)