Comparing nerve surgery and botulinum toxin for treating spastic foot after stroke
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
This study is testing whether surgery on a nerve or botulinum toxin injections work better to help adults who had a stroke and have a stiff foot move more easily and comfortably.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Bron and 3 other locations) |
| Trial ID | NCT05874154 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of tibial nerve selective neurotomy versus botulinum toxin injections for treating spastic foot in post-stroke patients. The study focuses on adults with hemiparesis who experience spasticity affecting their lower limbs, leading to difficulties in daily activities. Participants will be assessed for spasticity and must meet specific inclusion criteria to ensure they are suitable candidates for either intervention. The goal is to determine which treatment provides better outcomes for improving mobility and comfort.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with hemiparesis due to stroke, experiencing spasticity in their lower limbs.
Not a fit: Patients with known sensitivities to botulinum toxin or contraindications to surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients suffering from spastic foot, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown promising results with botulinum toxin for spasticity, but the tibial nerve selective neurotomy approach is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bron and 3 other locations
- Hôpital Pierre Wertheimer — Bron, France (Not_yet_recruiting)
- Ap-Hp — Clichy, France (Not_yet_recruiting)
- CHU de Nantes — Nantes, France (Not_yet_recruiting)
- Hôpital Henry Gabrielle — Saint-Genis-Laval, France (Recruiting)
Study contacts
- Study coordinator: Jacques LUAUTE, MD,PhD
- Email: jacques.luaute@chu-lyon.fr
- Phone: 04 72 35 71 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.