StrokeCRYOSTROKENCT06726434
Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke
A study testing Surgical neurotomy (SN) and Cryoneurotomy (CN) in people with Stroke and Equinovarus Foot, run by Poitiers University Hospital at 7 sites in France.
Trial summary
CRYOSTROKE study is designed : to compare the efficacy and safety of percutaneous CryoNeurotomie (CN) versus surgical neurotomy (SN) on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and, to ensure that potential clinical effect/safety remain stable within… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Equinovarus Foot, Refractory Lower Limb Spasticity
- What is being tested?
- Surgical neurotomy (SN) and Cryoneurotomy (CN)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 7 sitesFrance
- Study dates
- 9 Jul 2025to 9 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Hôpital Raymond Pointcarré
Garches, 92380
Marjorie SALGA, MD, +33 1 47 10 77 16, marjorie.salga@aphp.fr
- Recruiting
CHRU Montpellier
Montpellier, 34295
Flavia COROIAN, MD, +33 467338717, fo-coroian@chu-montpellier.fr
- Recruiting
C.H.U. Poitiers
Poitiers, 86000
Romain DAVID, MD, +33 5 49 44 44 54, romain.david@chu-poitiers.fr
- Recruiting
CHU Rennes
Rennes, 35000
Charles GUIGNANS, MD, +33 2 99 28 42 18, Charles.GUIGNANS@chu-rennes.fr
- Recruiting
Pôle Saint-Hélier
Rennes, 35000
Anne-Laure ROY, MD, +33 2 99 29 53 08, AnneLaure.ROY@fondationsainthelier.com
- Recruiting
CHU Saint-Etienne
Saint-Etienne, 44055
Etienne OJARDIAS, MD, +33 4 77 12 04 61, Etienne.Ojardias@chu-st-etienne.fr
- Not yet recruiting
Hôpital Purpan
Toulouse, 31059
Camille CORMIER, MD, +33 5 61 77 86 88, cormier.c@chu-toulouse.fr
About this study
Official title: Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke: a Multicenter, Randomized Controlled, Non-inferiority Trial
CRYOSTROKE study is designed :
- to compare the efficacy and safety of percutaneous CryoNeurotomie (CN) versus surgical neurotomy (SN) on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and,
- to ensure that potential clinical effect/safety remain stable within time, with a 12-month follow-up.
Read the detailed description
Stroke, arising from cerebral vascular hemorrhage or ischemia, represents a major health-care problem affecting more than 140,000 persons in France every year. One of the major concerns after stroke is impairment of the pyramidal tract and parapyramidal fibers, resulting in upper motor neuron syndrome and spasticity. Up to 20% to 40% of stroke survivors develop spasticity, which dramatically impacts health status, pain, functional capacity, and ultimately, quality of life. Spastic equinovarus foot (SEF) is the most common deformity due to lower limb spasticity and is defined as a combination of an abnormal plantar-flexion, inversion and adduction of the foot. Consequently, SEF severely impairs walking capability and mobility, impacting daily life activities and restricting social participation. In addition to therapeutical physical rehabilitation programs, two main treatments can be proposed. First, SEF can be initially treated with focal botulinum toxin injections that for reducing spasticity. However, botulinum toxin injections are effective for only a limited period of time, and iterative reinjections are required. Second, permanent treatment of spasticity can be achieved by surgical neurotomy. This procedure, variably combined with muscle and tendon lengthening in the event of associated retractions, can be considered as the long-term radical and effective gold standard, but at the price of surgical invasiveness and complications.
A recent alternative allowing for both permanent treatment and a minimally invasive approach has been introduced: "percutaneous cryoneurotomy". While this approach has provided promising results, as shown in multiple case reports, its efficacy has yet to be determined in a randomized control study.
CryoNeurotomy (CN) was first performed and developed in daily practice for the upper limb. Through a mentoring process, a feasibility study was performed on cadavers and transposed the technique to human procedures in a pilot study. The results from the first patients, with a 90-day follow-up period, are promising, with decreased spasticity and significantly increased walking capabilities. Major potential advantages of percutaneous CN compared to surgical neurotomy were identified, such as minimal skin incision, faster procedure, far less invasiveness of muscle tissue and adjacent neuro-vascular structures, particularly a decreased risk of post-operative sensory loss or neuropathic pain, no need for general anesthesia (local anesthesia) and possible performance on an outpatient basis. By enlarging Physical Medicine and Rehabilitation (PMR) therapeutical armamentarium, percutaneous CN could represent a new compromise between botulinum toxin iterative injections and radical surgery, in terms of invasiveness \& complications/long-term benefit ratio on spasticity and function.
The CRYOSTROKE study was designed:
- to compare the efficacy and safety of percutaneous CN versus surgical neurotomy on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and,
- to ensure that potential clinical effect/safety remain stable within time, with a 12-month follow-up.
- Conditions
- Stroke, Equinovarus Foot, Refractory Lower Limb Spasticity
- Being tested
- Surgical neurotomy (SN), Cryoneurotomy (CN)
- Keywords
- surgical neurotomy, CryoNeurotomy, spasticity, cryoneurolysis, percutaneous cryoneurolysis
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical neurotomy (SN)Procedure or surgery
Surgical neurotomy will be performed under general anesthesia according to the previous description. Muscle relaxant drugs will not be used in order to prevent any interference with the intraoperative electrical stimulation.
The patient will be placed in a prone position and a vertical cutaneous incision will be made at the popliteal fossa location.
The tibial nerve will be dissected and the motor nerve branches of the soleus, gastrocnemius, tibialis posterior and flexor hallucis longus will be identified with intraoperative tripolar electrical stimulation. The selected motor nerve branches will be partially sectioned over a 5mm length under the microscope. The extent of nerve section will be determined according to the degree of spasticity and to the intraoperative residual muscular contraction under electrical stimulation
Cryoneurotomy (CN)Procedure or surgery
After the use of an aseptic technique with 2% chlorhexidine, betadine application and a local anesthesia with lidocaine 1% (3ml), percutaneous cryoneurotomy will be performed with METRUM CRYOFLEX device guided by ultrasound with 1.2mm cryoprobe at -89°C placed through a #16 angio guide. Electrical stimulation will be performed to confirm tibial nerve contact at 0.8 mV.
The ice ball will be repositioned to two spots along the nerve. Each lesion will be treated for 2min cryoneurolysis at -89°C, followed by 2min without freezing (passive defreezing period) and 2min of cryoneurolysis at -89°C, based on cryotherapy for pain management.
| Study group | Role | What they receive |
|---|---|---|
| CryoNeurotomy (CN) | Experimental | Cryoneurotomy procedure Receives: Procedure: Cryoneurotomy (CN) |
| Surgical neurotomy (SN) | Active comparator | Surgical neurotomy procedure Receives: Procedure: Surgical neurotomy (SN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity).
Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity). This MAS will be quantified on a passive ankle dorsal flexion with knee extended (180°) movement.
Measured: Between baseline and 90-day follow-up
Secondary outcomes (19)
Mean absolute change in functional disability assessed using the Barthel Index (BI).
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in passive ankle dorsal flexion with knee flexed (90°) and extended (180°) movement spasticity assessed by the Modified Ashworth Scale (MAS)
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in muscle's response to stretch applied at given velocities assessed by the Tardieu Scale and the Modified Tardieu Scale (MTS)
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in maximal ankle range of motion (in degrees) assessed with a goniometer in slow and rapid movement
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in the Medical Research Council (MRC) scale of muscle strength of the impaired foot.
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in time in seconds to complete the 10-meter walking test
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in the distance in meters covered in the 6-min walking test
Measured: Between baseline and 90, 180 and 365-day follow-ups
Physical activity intensities: Mean absolute change in the rate of high, moderate, light activities bet
Measured: Between baseline and 90, 180 and 365-day follow-ups for a period of 7 days before each visit
Physical activity intensities: mean absolute change in number of steps measured with accelerometer (ActiGraph GT9X)
Measured: Physical activity intensities: mean absolute change in number of steps measured with accelerometer (ActiGraph GT9X)
Mean absolute change in pain surface using a digital mapping tool converting pain drawings to cm²
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in pain intensity and interference using the Brief Pain Inventory (BPI) questionnaire
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in quality of life: EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in fatigue: Brief Fatigue Inventory (BFI) questionnaire
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean goal attainment assessed with the Goal Attainment Scale (GAS) consisting in 3 main goals provided by the patient before intervention
Measured: Between baseline and 90, 180 and 365-day follow-ups
Mean patient satisfaction assessed with Patient Global Impression of Change Patient satisfaction (PGIC)
Measured: Between baseline and 90, 180 and 365-day follow-ups
Medico-economic impact measured with Health Care Utilization (HCU) costs
Measured: From baseline to 365-day post intervention in terms
Medico-economic impact measured with Employment status
Measured: From baseline to 365-day post intervention in terms
Medico-economic impact measured with medication intake
Measured: From baseline to 365-day post intervention in terms
Rates of adverse events & serious adverse events
Measured: From baseline to 365-day post intervention in terms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start9 Jul 2025
- Primary completion9 Apr 2029 (estimated)
- Study completion9 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726434
- Sponsor's protocol ID
- CRYOSTROKE
- Acronym
- CRYOSTROKE
- Status last verified
- Feb 2026
- First submitted
- 22 Nov 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke: a Multicenter, Randomized Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06726434
- Acronym / sponsor ID
- CRYOSTROKE / CRYOSTROKE
- Conditions
- Stroke, Equinovarus Foot, Refractory Lower Limb Spasticity
- Keywords
- surgical neurotomy, CryoNeurotomy, spasticity, cryoneurolysis, percutaneous cryoneurolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 9 Apr 2029 (estimated)
- Study completion
- 9 Jun 2029 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CRYOSTROKE study is designed :
- to compare the efficacy and safety of percutaneous CryoNeurotomie (CN) versus surgical neurotomy (SN) on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and,
- to ensure that potential clinical effect/safety remain stable within time, with a 12-month follow-up.
Detailed description
Stroke, arising from cerebral vascular hemorrhage or ischemia, represents a major health-care problem affecting more than 140,000 persons in France every year. One of the major concerns after stroke is impairment of the pyramidal tract and parapyramidal fibers, resulting in upper motor neuron syndrome and spasticity. Up to 20% to 40% of stroke survivors develop spasticity, which dramatically impacts health status, pain, functional capacity, and ultimately, quality of life. Spastic equinovarus foot (SEF) is the most common deformity due to lower limb spasticity and is defined as a combination of an abnormal plantar-flexion, inversion and adduction of the foot. Consequently, SEF severely impairs walking capability and mobility, impacting daily life activities and restricting social participation. In addition to therapeutical physical rehabilitation programs, two main treatments can be proposed. First, SEF can be initially treated with focal botulinum toxin injections that for reducing spasticity. However, botulinum toxin injections are effective for only a limited period of time, and iterative reinjections are required. Second, permanent treatment of spasticity can be achieved by surgical neurotomy. This procedure, variably combined with muscle and tendon lengthening in the event of associated retractions, can be considered as the long-term radical and effective gold standard, but at the price of surgical invasiveness and complications.
A recent alternative allowing for both permanent treatment and a minimally invasive approach has been introduced: "percutaneous cryoneurotomy". While this approach has provided promising results, as shown in multiple case reports, its efficacy has yet to be determined in a randomized control study.
CryoNeurotomy (CN) was first performed and developed in daily practice for the upper limb. Through a mentoring process, a feasibility study was performed on cadavers and transposed the technique to human procedures in a pilot study. The results from the first patients, with a 90-day follow-up period, are promising, with decreased spasticity and significantly increased walking capabilities. Major potential advantages of percutaneous CN compared to surgical neurotomy were identified, such as minimal skin incision, faster procedure, far less invasiveness of muscle tissue and adjacent neuro-vascular structures, particularly a decreased risk of post-operative sensory loss or neuropathic pain, no need for general anesthesia (local anesthesia) and possible performance on an outpatient basis. By enlarging Physical Medicine and Rehabilitation (PMR) therapeutical armamentarium, percutaneous CN could represent a new compromise between botulinum toxin iterative injections and radical surgery, in terms of invasiveness \& complications/long-term benefit ratio on spasticity and function.
The CRYOSTROKE study was designed:
- to compare the efficacy and safety of percutaneous CN versus surgical neurotomy on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and,
- to ensure that potential clinical effect/safety remain stable within time, with a 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CryoNeurotomy (CN) | Experimental | Procedure: Cryoneurotomy (CN)Cryoneurotomy procedure |
| Surgical neurotomy (SN) | Active comparator | Procedure: Surgical neurotomy (SN)Surgical neurotomy procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical neurotomy (SN)Surgical neurotomy will be performed under general anesthesia according to the previous description. Muscle relaxant drugs will not be used in order to prevent any interference with the intraoperative electrical stimulation. The patient will be placed in a prone position and a vertical cutaneous incision will be made at the popliteal fossa location. The tibial nerve will be dissected and the motor nerve branches of the soleus, gastrocnemius, tibialis posterior and flexor hallucis longus will be identified with intraoperative tripolar electrical stimulation. The selected motor nerve branches will be partially sectioned over a 5mm length under the microscope. The extent of nerve section will be determined according to the degree of spasticity and to the intraoperative residual muscular contraction under electrical stimulation | Procedure or surgery | Surgical neurotomy (SN) |
| Cryoneurotomy (CN)After the use of an aseptic technique with 2% chlorhexidine, betadine application and a local anesthesia with lidocaine 1% (3ml), percutaneous cryoneurotomy will be performed with METRUM CRYOFLEX device guided by ultrasound with 1.2mm cryoprobe at -89°C placed through a #16 angio guide. Electrical stimulation will be performed to confirm tibial nerve contact at 0.8 mV. The ice ball will be repositioned to two spots along the nerve. Each lesion will be treated for 2min cryoneurolysis at -89°C, followed by 2min without freezing (passive defreezing period) and 2min of cryoneurolysis at -89°C, based on cryotherapy for pain management. | Procedure or surgery | CryoNeurotomy (CN) |
Primary outcome
Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity).
Time frame: Between baseline and 90-day follow-up
Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity). This MAS will be quantified on a passive ankle dorsal flexion with knee extended (180°) movement.
19 secondary outcomes
Mean absolute change in functional disability assessed using the Barthel Index (BI).
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in passive ankle dorsal flexion with knee flexed (90°) and extended (180°) movement spasticity assessed by the Modified Ashworth Scale (MAS)
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in muscle's response to stretch applied at given velocities assessed by the Tardieu Scale and the Modified Tardieu Scale (MTS)
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in maximal ankle range of motion (in degrees) assessed with a goniometer in slow and rapid movement
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in the Medical Research Council (MRC) scale of muscle strength of the impaired foot.
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in time in seconds to complete the 10-meter walking test
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in the distance in meters covered in the 6-min walking test
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Physical activity intensities: Mean absolute change in the rate of high, moderate, light activities bet
Time frame: Between baseline and 90, 180 and 365-day follow-ups for a period of 7 days before each visit
Physical activity intensities: mean absolute change in number of steps measured with accelerometer (ActiGraph GT9X)
Time frame: Physical activity intensities: mean absolute change in number of steps measured with accelerometer (ActiGraph GT9X)
Mean absolute change in pain surface using a digital mapping tool converting pain drawings to cm²
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in pain intensity and interference using the Brief Pain Inventory (BPI) questionnaire
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in quality of life: EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean absolute change in fatigue: Brief Fatigue Inventory (BFI) questionnaire
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean goal attainment assessed with the Goal Attainment Scale (GAS) consisting in 3 main goals provided by the patient before intervention
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Mean patient satisfaction assessed with Patient Global Impression of Change Patient satisfaction (PGIC)
Time frame: Between baseline and 90, 180 and 365-day follow-ups
Medico-economic impact measured with Health Care Utilization (HCU) costs
Time frame: From baseline to 365-day post intervention in terms
Medico-economic impact measured with Employment status
Time frame: From baseline to 365-day post intervention in terms
Medico-economic impact measured with medication intake
Time frame: From baseline to 365-day post intervention in terms
Rates of adverse events & serious adverse events
Time frame: From baseline to 365-day post intervention in terms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical neurotomy (SN) and Cryoneurotomy (CN) in people with Stroke and Equinovarus Foot, run by Poitiers University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain DAVID, MD (+33 5 49 44 44 54, romain.david@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity). (time frame: Between baseline and 90-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.