Clinical trial NCT05874154: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Stroke Seizure
Spastic Foot
Keywords: Tibial nerve selective neurotomy
botulinum toxin
spastic foot
post-stroke patient
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of the value of Goal Attainment Scaling
timeFrame: through study completion, 14 months
Secondary outcomes:
measure: Evolution of Functional outcomes
timeFrame: through study completion, 14 months
measure: Tardieu's scale
timeFrame: through study completion, 14 months
measure: Modified Ashworth scale
timeFrame: through study completion, 14 months
measure: Evolution of ankle motion range
timeFrame: through study completion, 14 months
measure: Proportion of patients with antispastic drug
timeFrame: through study completion, 14 months
measure: measure of pain level
timeFrame: through study completion, 14 months
measure: Proportion of patients with adverse event
timeFrame: through study completion, 14 months
measure: Psychometric qualities of the Consumer satisfaction questionnaire (named CSQ-8)
timeFrame: through study completion, 14 months
measure: 10 meter walk test - speed
timeFrame: through study completion, 14 months
measure: 10 meter walk test - distance
timeFrame: through study completion, 14 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
city: Clichy
country: France
facility: AP-HP
city: Nantes
country: France
facility: CHU de Nantes
city: Saint-Genis-Laval
country: France
facility: Hôpital Henry Gabrielle
Study officials:
References: