Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT06726434
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old.
* Patient with spastic equinovarus foot as a result of stroke in chronic phase (\>6 months).
* Patient with positive perineural motor block test with or without complete correction of spastic equinus and non-persistence of 40° equinus.
* Patient eligible for surgical neurotomy for varus equinus foot.
* Patient presenting no cognitive impairment or major depression (Mini Mental State Examination\>20, Hospital Anxiety and Depression (HAD\<11)).
* Absence of active psychosis or history of serious psychotic illness requiring hospitalization
* Patient understanding and accepting the constraints of the study.
* Patient covered by French national health insurance.
* Patient who has given their written consent to the study after having received clear information.
Exclusion Criteria:
* Patient with previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery at the same anatomical site.
* Patient with any neurological pathology different from the one responsible for the spasticity.
* Patient with botulinum toxin in lower limb injection during the last 90 days before intervention.
* Patient with anti-spastic treatment (baclofene) up 3 days before block test.
* Patient with total deficit of valgus muscles.
* Patient with equinus foot \> 40° (retractions/ankylosis).
* Surgical and anesthetic contra-indications (severe uncontrolled coagulation disorder, active infection).
* Cryoneurotomy contra-indications (cold intolerance, cryoglobulinemia, cryofibrinogenemia, Raynaud's phenomena, venous thromboemolism (\< 3 months if superficial, \< 6 months if deep), hypothyreosis, cold urticari, local disorders of blood supply, considerable anemia, cachexia, hypothermia, cancer disease, infection, coagulopathy…).).
* Subject requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection (temporary or permanent guardianship and, subject to subordination), and finally patients in an emergency setting.
* Pregnant woman, nursing mother, woman of childbearing potential not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06726434
Study Brief:
Protocol Section:
NCT06726434