Freezing nerve treatment could replace surgery for stroke foot deformity
NCT ID NCT06726434
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a less invasive freezing technique (cryoneurotomy) works as well as surgery to reduce foot stiffness in people who had a stroke. About 114 adults with chronic foot spasticity will be randomly assigned to one of the two treatments. The goal is to see if the freezing method can ease symptoms and improve walking without the need for open surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2025
- Expected to finish
-
Jun 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Equinovarus foot are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
7 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
C.H.U. Poitiers
RECRUITINGPoitiers, 86000, France
-
CHRU Montpellier
RECRUITINGMontpellier, 34295, France
-
CHU Rennes
RECRUITINGRennes, 35000, France
-
CHU Saint-Etienne
RECRUITINGSaint-Etienne, 44055, France
-
Hôpital Purpan
NOT_YET_RECRUITINGToulouse, 31059, France
-
Hôpital Raymond Pointcarré
RECRUITINGGarches, 92380, France
-
Pôle Saint-Hélier
RECRUITINGRennes, 35000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Robot could let stroke patients rehab their hands at home without a therapist
- Moving patterns may help stroke survivors read faster
- Vibrating wearables put stroke walking to the test
- Robot plus electrical stimulation aims to rebuild arm movement after stroke
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next