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

Spastic Foot Clinical Trial

— FOOTNEUROTOX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874154
• Other study ID #: 69HCL22_0905
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: June 2, 2026

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Jacques LUAUTE, MD,PhD
• Phone: 04 72 35 71 69
• Email: jacques.luaute[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2, 2026
• Est. primary completion date: June 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Post Stroke Seizure
• Seizures
• Spastic Foot
• Stroke

Intervention

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
France	Hôpital Pierre Wertheimer	Bron
France	AP-HP	Clichy
France	CHU de Nantes	Nantes
France	Hôpital Henry Gabrielle	Saint-Genis-Laval

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evolution of Functional outcomes	Functional outcomes before treatment, at 5 weeks and 3 months using Goal Attainment Scaling primary outcome scoring	through study completion, 14 months
Secondary	Tardieu's scale	Tardieu's scale assesses spasticity with movement velocity, muscle reaction angle and quality.	through study completion, 14 months
Secondary	Modified Ashworth scale	-Modified Ashworth scale, measures spasticity level according to a level scale (0,1,1+,2,3,4), 0=absence of muscle tone increase and 4=rigidity in flexion or extension of affected part(s)	through study completion, 14 months
Secondary	Evolution of ankle motion range	Active and/or passive ankle motion range Improvement at 5 weeks, 3 months and endpoint	through study completion, 14 months
Secondary	Proportion of patients with antispastic drug		through study completion, 14 months
Secondary	measure of pain level	Pain type using a self-rating scale for estimating the likelihood of neuropathic painscale before treatment (named DN4), at 5 weeks, 3 months and endpoint using a 0 to 10 visual analogic scale	through study completion, 14 months
Secondary	Proportion of patients with adverse event	Adverse effects by systematic assessment at 5 weeks, 3 months and endpoint.	through study completion, 14 months
Secondary	Psychometric qualities of the Consumer satisfaction questionnaire (named CSQ-8)	Patient reported Experience Measures will be assessed at endpoint with the CSQ-8 questionnaire	through study completion, 14 months
Secondary	10 meter walk test - speed	Walking speed with the 10 meter walk test (10MWT)	through study completion, 14 months
Secondary	10 meter walk test - distance	distance improvement assessed using the 6 minutes walking test (6MWT)	through study completion, 14 months