Informations générales (source: ClinicalTrials.gov)
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 (FOOTNEUROTOX)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2024
mars 2027
15 juillet 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - 92110 - Clichy - France | Pjilippe ² DECQ, MD,PhD | Contact (sur clinicalTrials) | |||
| CHU de Nantes - 44093 - Nantes - France | Kevin BUFFENOIR, MD,PhD | Contact (sur clinicalTrials) | |||
| Hôpital Henry Gabrielle - 69230 - Saint-Genis-Laval - France | Jacques LUAUTE, MD,PhD | Contact (sur clinicalTrials) | |||
| Hôpital Pierre Wertheimer - 69394 - Bron - France | Patrick MERTENS, MD,PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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