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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 2, 2024

Primary Completion Date

March 2, 2027

Study Completion Date

March 2, 2027

Conditions
Post Stroke SeizureSpastic Foot
Interventions
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.

Trial Locations (4)

44093

NOT_YET_RECRUITING

CHU de Nantes, Nantes

69230

RECRUITING

Hôpital Henry Gabrielle, Saint-Genis-Laval

69394

NOT_YET_RECRUITING

Hôpital Pierre Wertheimer, Bron

92110

NOT_YET_RECRUITING

AP-HP, Clichy

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER