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
| NCT ID | NCT05874154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Post Stroke Seizure |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2027-03-02 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-01-02 with a primary completion date of 2027-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05874154 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Post Stroke Seizure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05874154 currently recruiting?
Yes, NCT05874154 is actively recruiting participants. Contact the research team at jacques.luaute@chu-lyon.fr for enrollment information.
Where is the NCT05874154 trial being conducted?
This trial is being conducted at Bron, France, Clichy, France, Nantes, France, Saint-Genis-Laval, France.
Who is sponsoring the NCT05874154 clinical trial?
NCT05874154 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 60 participants.
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