NCT05874154: FOOTNEUROTOX

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

Recruiting now NA Last updated 14 July 2025

What this trial tests

NA trial testing Tibial nerve selective neurotomy in Post Stroke Seizure in 60 participants. Currently enrolling.

Timeline

2 January 2024

Primary endpoint
2 March 2027

2 March 2027

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	60
Start date	2 January 2024
Primary completion	2 March 2027
Estimated completion	2 March 2027
Sites	4 locations across France

Drugs / interventions tested

• Tibial nerve selective neurotomy
• Botulinum toxin injection

Conditions studied

• Post Stroke Seizure — all drugs for Post Stroke Seizure →
• Spastic Foot — all drugs for Spastic Foot →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 100, any sex, with Post Stroke Seizure or Spastic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.